Changes in the Oral-Health-Related Quality of Life of Thai patients with oral lichen planus after topical corticosteroid treatment: a 1-month longitudinal study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Changes in the Oral-Health-Related Quality of Life of Thai patients with oral lichen planus after topical corticosteroid treatment: a 1-month longitudinal study Witchapat Kengtong, Pornpan Piboonratanakit, Sudaduang Krisdapong This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3153939/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 21 Nov, 2023 Read the published version in BMC Oral Health → Version 1 posted 10 You are reading this latest preprint version Abstract Background Oral lichen planus (OLP) is a common chronic inflammatory disease of the oral cavity that affects many patients’ daily living activities. The goal of treating OLP is to relieve symptomatic pain, and reduce inflammation. Topical corticosteroids are the first-line drug for treating OLP. OLP clinical trials should use a tripartite approach comprising clinical signs, symptoms, and quality of life. The Oral Impact on Daily Performances index (OIDP) is an Oral-Health-Related Quality of Life (OHRQoL) measure developed to assess the ultimate impacts. The aims of this study were to evaluate the clinical, pain and OHRQoL responses after treating OLP patients with topical corticosteroids for 1 month, and secondly to assess the relationships of changes in the clinical sign score, pain score, and OHRQoL. Methods Seventy-two OLP patients were recruited to assess their clinical outcomes and patient-based outcomes after treating them with topical corticosteroids for 1 month. The clinical outcomes were evaluated by the highest and total Thongprasom sign score. The patient-based outcomes were evaluated by a pain rating scale using a numeric rating scale (NRS), and OIDP. The self-rated overall changes in quality of life during the 1-month treatment period using the Patient Global Impression of Change (PGIC) were also recorded at the follow-up visit. Results This study comprised 59 women (81.9%) and 13 men (18.1%). The total OIDP percentage score was 19.1 ± 10.5 at baseline. The most commonly affected activities were Emotional stability (94.4%), followed by Eating (86.1%) and Cleaning the oral cavity (65.3%). At the 1-month follow-up visit, the highest Thongprasom sign score, total Thongprasom sign score, pain score and total OIDP percentage score were significantly reduced after treatment with topical corticosteroids ( P < 0.01). None of the patients reported a lower quality of life. Forty-six percent reported the same or up to moderately improved, while 54% had a greatly improved quality of life as assessed by PGIC. There were no significant differences in the improvement of clinical and patient-based outcomes between these outcome groups. There were significant relationships between the difference in the highest Thongprasom sign score and the difference in total Thongprasom sign score (r = 0.293; P < 0.05), and the differences in total OIDP percentage score and the difference in pain score (r = 0.427; P < 0.001). The differences in the total Thongprasom sign score also significantly related to the difference in the total OIDP percentage score (r = 0.335; P < 0.01). However, no significant relationship was found between the difference in the highest Thongprasom sign score and the difference in patient-based outcomes. Conclusion Topical corticosteroids were significantly effective after 1-month treatment of OLP based on the clinical and patient-based outcomes. The OHRQoL improvement was significantly related to the reductions in pain and clinical severity. Trial registration The trial was registered at the Thai Clinical Trials Registry (TCTR identifier: TCTR 20221110001). Oral lichen planus Quality of life Oral health related quality of life Oral impact on daily performances index OIDP Topical corticosteroid treatment Background Oral lichen planus (OLP) is a common chronic inflammatory disease of the oral cavity that affects the daily living activities in many patients. Most OLP patients are middle-aged women; the most common lesion sites are the buccal mucosa followed by the tongue, and gingiva [1]. OLP occurs in several forms, with the classic forms being white lesions presenting as reticular, papular, or plaque-like patterns and red lesions presenting as atrophic and ulcerative areas [2]. The main symptoms of OLP are a burning sensation when eating hot and spicy foods or severe chronic pain in the oral cavity [3]. The goal of treating OLP is to relieve symptomatic pain and reduce inflammation. The first-line drugs for treating OLP are corticosteroids taken in topical forms that can be used in various types and preparations, such as fluocinolone acetonide oral paste and dexamethasone mouthwash [4–6]. The advantages of topical corticosteroids are the lower risk of systemic steroid effects, such as hypertension, gastric ulcers, bone mineral loss, or adrenal suppression, however, they have an increased risk of oral candidiasis when used over a prolonged period [7]. Currently, OLP clinical trials should use a tripartite approach comprising clinical signs, symptoms, and quality of life [8]. Chainani-Wu et al. [9] recommended using an instrument that was sensitive and easy to apply when evaluating the signs of OLP. For clinical evaluation, several OLP studies applied the Thongprasom sign scoring system [5, 10–12]. This scoring system takes the size and clinical severity of each OLP lesion into account, however, only the highest score is assigned for a patient regardless of the number of lesions. Unlike the Thongprasom sign scoring system, some systems take into account the number of lesions and the severity of each lesion [8, 9]. Because OLP was a chronic inflammatory disease that is very difficult to completely cure, patients suffer from a burning sensation, pain, and discomfort [13]. Pain rating scales, e.g. numeric rating scale (NRS) and visual analog scale (VAS), are widely accepted and are more useful for assessing OLP symptoms [9]. Several OLP longitudinal studies used these scales for assessing OLP symptoms [11, 14–16]. Moreover, the concept of patient-based outcome measures has been used to determine impaired oral health from the patient's perspective using the Oral-Health-Related Quality of Life (OHRQoL) [17]. These perspectives can be measured by several indices, such as the Oral Health Impact Profile (OHIP), Oral Health-related Quality of Life (OHQoL) and Chronic Oral Mucosal Disease Questionnaire (COMDQ) [18]. Several OLP longitudinal studies chose OHIP or OHQoL as instruments to determine the patient-centered outcomes along with the efficacy of the drugs after treatment [12, 15, 16]. Furthermore, COMDQ was one of the measurements used in a phase II study of clobetasol patches for treating OLP [14]. The Oral Impact on Daily Performances Index (OIDP) [19] is another OHRQoL measure developed to assess the ultimate impacts, i.e. difficulties in daily life performances that are the consequences of intermediate impacts, e.g. pain, discomfort, functional limitations, and dissatisfaction with appearance, thus, avoiding repetition in measuring the impacts. If pain as the intermediate impact leads to difficulty in eating as the ultimate impact, OIDP will consider only difficulty in eating. In oral medicine, OIDP was used to assess the oral impacts attributed to angular cheilitis, and geographic tongue in the Portuguese version [20]. The Arabic OIDP version was applied to assess the relationship between OHRQoL and oral lesions related to skin lesions [21]. In Thailand, this index has been validated in all age groups and widely applied in several dental specialties’ clinical research and in Thailand national health surveys [22–25]. There was also an investigation of OHRQoL attributed to recurrent aphthous stomatitis in Thai children in a national oral health survey using OIDP [26]. Yiemstan et al. [27] also used the Thai OIDP version for investigating the associations of OHRQoL and pain with clinical signs based on the Thongprasom sign scoring system in OLP patients. The previous studies about oral mucosal lesions that used OIDP were cross-sectional and case-control studies, whereas most OLP longitudinal studies used OHIP and OHQoL for OHRQoL evaluation. None of the OLP longitudinal studies used OIDP to measure OHRQoL. Therefore, the aim of this study was to evaluate the clinical, pain and OHRQoL responses after a 1-month treatment with topical corticosteroid in OLP patients. Secondly, to assess the relationships of the changes in the clinical sign score, pain score, and OHRQoL. Methods Study subjects The sample size was calculated using 80% power and 95% confidence level according to data from McGrath et al. [15]. They assessed the OHRQoL in patients with OLP treated with topical betamethasone using OHQoL-UK and OHIP-14 questionnaires. The effect size (ρ) was 0.31, thus, the estimated total sample size was 66. To compensate for error or loss of participants during follow up, the sample size was increased by 10%, resulting in 72 patients. The patients were recruited from the Oral Medicine clinic, Faculty of Dentistry, Chulalongkorn University. The inclusion criteria were being over 18 years old, patients diagnosed with OLP or compatible with OLP following clinical and histopathological criteria [28], oral lichenoid drug reaction (OLDR) patients with a history of taking a related medication, patients receiving topical corticosteroid for OLP treatment, follow-up patients requiring follow-up appointment for 1 month, and patients with written informed consent. The exclusion criteria were pregnant patients, patients with a history of smoking within six months, patients who were treated with other modalities or had other types of oral mucosal lesions, or oral lichenoid contact lesion patients. The interviewer was trained and calibrated with an expert in using the OIDP index. The inter-rater agreement was good with an intraclass correlation coefficient (ICC) of 0.877. Data collection Demographic data Age, sex, systemic condition, medication taking and OLP duration since the first diagnosis were collected from the history taking at the first visit. In addition, the OLP locations (e.g. lips, labial mucosa, buccal mucosa, gingiva, tongue, floor of the mouth, and palate), experience with OLP treatment (i.e., new or follow-up patient) and prescribed topical corticosteroids were also recorded. Clinical outcomes Regarding the clinical data collection, the highest Thongprasom sign score was based on the original Thongprasom sign scoring system, i.e., "0" indicated no lesions; "1" indicated white striae only, "2" indicated white striae with an atrophic area of less than 1 cm 2 , "3" indicated white striae with an atrophic area of 1 cm 2 or more, "4" indicated white striae with an erosive area of less than 1 cm 2 and "5" indicated white striae with an erosive area of 1 cm 2 or more ( 5 ). The highest Thongprasom sign score obtained from the most severe lesion ranging from 0–5, was assigned to the patient. The total Thongprasom sign score, which was the sum of all lesions’ Thongprasom sign scores, was calculated. The OLP distribution was recorded as the outer and inner lips, right and left buccal mucosa, upper right, upper central, upper left, lower left, lower central, and lower right gingiva, dorsal, left and right ventrolateral tongue, floor of the mouth, hard palate, and soft palate [9]. Because the possible maximum number of OLP oral lesions was 16, the total Thongprasom sign scores ranged from 0–80. The highest and total Thongprasom sign scores were recorded at baseline and the follow-up visit Patient-based outcomes The patients were asked about the chief symptoms of OLP that made them visit the dentist at baseline, such as a burning sensation, ulceration, and roughness. The patients could have more than 1 symptom or have no symptoms. In the aspect of pain, the OLP patients reported their NRS score for their worst pain during 1 month at baseline and the follow-up visit [29], ranging from 0–10: "0" meant no pain at all, and "10" meant the worst pain imaginable. The patients’ OHRQoL was assessed using the Thai version of the OIDP [22]. The patients were asked about the OLP that limited their eight daily activities at baseline and the 1-month follow-up visit. The eight activities consisted of Eating, Speaking, Cleaning the oral cavity, Relaxing including sleeping, Smiling, laughing without embarrassment, Emotional stability, Carrying out major work and Social contact. The frequency and severity scores of difficulties, if any, on performing each activity were recorded. Due to the chronic nature of OLP, frequency scores on a regular basis was used: "0" meant never affected, "1" meant once a month, "2" meant twice a month, "3" meant once or twice a week "4" meant three to four times a week and "5" meant every or almost every day. The severity scores were scored as: "0" meant never affected daily life, "1" meant very low impact, "2" meant low impact, "3" meant moderate impact, "4" meant high impact, and "5" meant very high impact. The frequency and severity scores of difficulties on performing each activity were multiplied, resulting in a performance score ranging from 0–25. The sum of the eight performance scores ranging from 0–200 was divided by 2 to get a total OIDP percentage score ranging from 0–100. The higher scores indicated a poorer OHRQoL [19]. At the 1-month follow-up visit, the differences in each outcome were calculated by subtracting the follow-up data from the baseline data. Negative values represented a worsened effect, whereas positive values represented an improved effect. The differences in the mean values were determined. In addition, the OLP patients were asked to self-rate the overall changes in quality of life during the 4-week treatment period. The rating criteria from the Patient Global Impression of Change (PGIC) measure [30] were used. The PGIC was categorized on a 7-point scale as "severely worsened", "moderately worsened", "minimally worsened", "no change", "minimally improved", "moderately improved", and "greatly improved”. Data analysis Statistical calculations were performed with SPSS software (SPSS 22.0 for Windows; SPSS, Chicago, IL, USA). Descriptive statistics were used for the demographic and clinical data. The Kolomogonov-Smirnov normality tests were performed to determine the normal data distribution in each outcome. The pain score and total Thongprasom sign score between baseline and after the 1-month treatment were assessed using the paired t-test. The highest Thongprasom sign score, total OIDP percentage score, and performance scores of each daily activity between baseline and after the 1-month treatment were analyzed by the Wilcoxon signed-rank test. The differences in the highest Thongprasom sign score, total Thongprasom sign score, pain score and total OIDP percentage score between two groups of patients who reported no changes to moderately-improved and greatly-improved PGIC were tested using the Mann-Whitney U test. Pearson’s correlation was used to assess the relationship between the differences in the total OIDP percentage score, highest Thongprasom sign score, total Thongprasom sign score and pain score. The significance level was set at P < 0.05. Results OLP patient characteristics The 72 patients (100% response rate) in this study consisted of 59 women (81.9%) and 13 men (18.1%). The mean age of the patients in this study was 53.3 ± 12.4 years old (range 22–81 years old). Forty-six patients (63.9%) were between 30 and 60 years old. Twenty-three patients (31.9%) were more than 60 years old and 3 patients (4.2%) were less than 30 years old. Sixty patients (83.3%) in this study were new patients and 12 patients (16.7%) were follow-up patients. (Table 1.) Concerning the patients’ systemic condition, 40 patients (55.6%) reported no medical problems and were not taking any medications. Twenty-two patients (30.6%) were diagnosed with dyslipidemia and took anti-dyslipidemia drugs. Furthermore, 20 (27.8%) of the patients had hypertension and 9 (12.5%) had diabetes mellitus. Both diseases can require more than one group of drugs to treat them as 27 drugs (37.5%) for hypertension patients and 13 drugs (18.1%) for diabetic patients were reported. There were also 4 patients (5.6%) with thyroid disease and 2 patients (2.8%) with gout taking levothyroxine and allopurinol, respectively. (Table 1.) Fifty-one patients (70.8%) had their OLP less than 1 year before seeing the dentist, however, 14 patients (19.4%) were diagnosed 1–3 years earlier. Seven patients (9.8%) had their lesions for more than 3 years. The mean duration of OLP was 21.3 ± 30.1 months (range 1–120 months). OLP occurred in various sites in the oral cavity, with the most commonly afflicted area being the buccal mucosa (80.6%) followed by gingiva (76.4%), tongue (18.1%), lips (16.7%), and floor of the mouth (11.1%). Less than 10% of the patients demonstrated OLP at the palate (6.9%) and labial mucosa (5.6%). (Table 1.) The most frequently prescribed topical corticosteroids were 0.1% fluocinolone acetonide in orabase (37.5%), followed by 0.05% dexamethasone mouthwash (31.9%), 0.1% triamcinolone mouthwash (16.6%) and 0.05% fluocinolone mouthwash (15.3%). Other topical corticosteroids, 0.05% clobetasol propionate in orabase (2.8%) and 0.1% fluocinolone solution (1.4%), were infrequently prescribed. (Table 1.) Clinical and patient-based outcomes at baseline Some patients reported more than one complaint at the first visit. Common patients’ chief complaints were a burning sensation in the oral cavity (80.6%), having an ulceration (65.3%), and a rough oral mucosal surface (19.4%), however, 1 patient had no symptoms (1.4%). (Table 1.) At baseline, the average highest Thongprasom sign score was 3.9 ± 2.9 (range 2–5) and the average total Thongprasom sign score was 13.7 ± 6.8 (range 2–30). (Table 2.) At baseline, the mean pain score was 6.7 ± 2.6 (range 0–10) and the total OIDP percentage score was 19.1 ± 10.5 (range 1.5–48). (Table 2.) The three most commonly affected activities were Emotional stability (94.4%), Eating (86.1%) and Cleaning the oral cavity (65.3%). Fewer patients had problems in Social contact (20.8%), Carrying out major work (13.9%), Speaking (12.5%) and Smiling, laughing without embarrassment (12.5%). No patient reported relaxing disturbance due to OLP. (Table 3.) At baseline, the activity with the highest performance score was Eating (mean ± SD; 14.6 ± 6.1), followed by Emotional stability (mean ± SD; 13.6 ± 7.5), Cleaning the oral cavity (mean ± SD; 12.5 ± 6.1), and Smiling without embarrassment (mean ± SD; 11.4 ± 6.4). The performance scores of 3 other activities, i.e., Speaking, Social contact, and Carrying out major work, were less than 10. (Table 3.) Clinical and patient-based outcomes after 1-month treatment At the 1-month follow-up visit, the mean highest Thongprasom sign score was 2.1 ± 0.8 (range 1–4), thus, the difference in score from baseline was 1.1 ± 0.8 (range -1 to 3). The total Thongprasom sign score was 8.7 ± 5.2 (range 0–26), thus, the difference from baseline was 5.2 ± 4.1 (range-1 to 16). Both clinical outcomes significantly improved after 1-month treatment with topical corticosteroids ( P < 0.01). (Table 2.)At the 1-month follow-up visit, the pain score was 2.9 ± 2.2 (range 0–10) and the reduced pain score was 3.8 ± 2.5 (range 0–10). The pain score also significantly reduced after 1-month treatment ( P < 0.01). The total OIDP percentage score after 1-month treatment was 3.9 ± 4.8 (range 0–31) and its difference in total OIDP percentage score was 15.2 ± 8.9 (range 1.5–47), which was significantly lower compared with that at baseline ( P < 0.01). (Table 2.) At the follow-up visit, the OIDP performance scores of Eating (mean ± SD; 3.9 ± 4.3), Emotional stability (mean ± SD; 3.3 ± 4.6), and Cleaning the oral cavity (mean ± SD; 1.0 ± 2.6) were significantly decreased compared with those at baseline ( P < 0.01). In addition, the OIDP performance scores of the other 4 activities; Social contact (mean ± SD; 2.9 ± 1.7), Carrying out major work (mean ± SD; 1.9 ± 2.8), Speaking (mean ± SD; 1.3 ± 2.8), and Smiling, laughing without embarrassment (mean ± SD; 1.9 ± 2.9), were also significantly decreased compared with those at baseline ( P < 0.05). (Table 3.) The differences in the mean of each performance are also presented in Table 3. The mean ± SD of differences in Cleaning was 11.5 ± 6.0, followed by Eating (11.0 ± 6.3), Emotional stability (10.1 ± 7.3), Smiling without embarrassment (9.9 ± 6.4), Speaking (6.1 ± 7.6), Social contact (6.1 ± 4.8) and Working (3.5 ± 2.4). Patient global impression of change (PGIC) After 1-month treatment with topical corticosteroid, none of the patients reported severely worsened, moderately worsened or minimally worsened quality of life. One patient (1.4%) reported no changes after treatment. Four patients (5.6%) described themselves as minimally improved, 28 patients (38.9%) felt moderately improved, and 39 patients (54.2%) felt greatly improved. Therefore, we made 2 groups of patients that were the same or up to moderately improved (45.8%) and greatly improved (54.2%) quality of life groups to compare the reduced clinical and patient-based outcomes. The differences in total OIDP percentage score were 12.9 ± 7.0 in the same or up to moderately improved group and 17.2 ± 10.0 in the greatly improved group ( P = 0.079). In contrast, the differences in the mean of other outcomes, consisting of the highest Thongprasom sign score, total Thongprasom sign score, and pain scores demonstrated similar values or slight differences between the groups ( P = 0.528, P = 0.820, and P = 0.233, respectively). (Table 4.) Relationships between the differences in the mean clinical and patient-based outcomes The difference in total OIDP percentage score and difference in pain score demonstrated a significant relationship (r = 0.427; P < 0.001) and the difference in total OIDP percentage score and difference in total Thongprasom sign score was significantly related (r = 0.335; P < 0.01). There was a significant relationship between the difference in the highest Thongprasom sign score and the difference in total Thongprasom sign score (r = 0.293; P = 0.012). No significant relationship was found between the difference in the highest Thongprasom sign score and the difference in total OIDP percentage score (r = 0.198; P = 0.096), or between the differences in the highest Thongprasom sign score or total Thongprasom score and the difference in pain score (r = 0.109; P = 0.362 and r = 0.118; P = 0.324, respectively). (Table 5.) Discussion This was the first longitudinal study to assess OHRQoL using OIDP in patients treated for OLP. Moreover, this was also the first study using a total scoring system based on the Thongprasom sign scoring system for the severity due to OLP. Most of the patients participating in this study benefited from using topical corticosteroids, as demonstrated by the improvement in the clinical and patient-based outcomes. We found that the highest and total Thongprasom sign scores for OLP were significantly decreased after 1-month treatment with topical corticosteroids compared with baseline. Several reviews revealed that topical corticosteroids are clinically effective and are considered the treatment of choice for OLP [31, 32]. Thongprasom et al. [5] found no significant clinical improvement in 2 weeks, however, after 4 weeks, more than 60% of OLP patients who used 0.1% fluocinolone acetonide in orabase had the highest Thongprasom sign score of less than 2. Furthermore, there have been multiple clinical trials supporting that improvement in clinical sign scores and OLP symptoms can be detected after at least 4 weeks [10, 33]. Hegarty et al. [16] found that topical corticosteroids reduced the signs and symptoms of OLP within 3–4 weeks, thus, these drugs were effective in the early treatment of symptomatic OLP. OLP affects patient’s quality of life, however, effective treatment can improve their ability to perform everyday activities [16]. One of the goals of OLP treatment with topical corticosteroids is to have the patients recover their ability to perform the basic activities of daily life, such as eating, drinking, or tooth brushing [34]. In the present study, the three activities with the highest prevalence were Emotional stability followed by Eating, and Cleaning the oral cavity. The total OIDP percentage score was also significantly decreased. Moreover, all performances, except for Relaxing including sleeping, in which no patient reported difficulty before receiving treatment, improved by more than 80% after 1 month. These results indicate that the OLP patients achieved a better quality of life in every important domain after 1-month treatment with topical corticosteroids. Our results corresponded to those of a previous study in which OLP patients had a significant negative impact on OHIP (e.g. functional limitation, physical disability, physical pain and psychological discomfort) and all these impacts were improved after topical corticosteroid treatment [12]. Previous longitudinal OLP studies using OHIP and OHQoL as OHRQoL assessment tools also found a significant improvement in OHRQoL in OLP patients after treating them with topical corticosteroids by 3–6 weeks [15, 16]. Hambly et al. [6] reported that their patients could consume spicy foods or felt more confident after using topical corticosteroids to treat their OLP. The PGIC, the patients’ perception on their changing OHRQoL, results revealed that most patients reported improvement in various scales. However, the difference in the reduced clinical, pain and OIDP scores between those reporting up to moderately improved and greatly improved were not significant. Feine et al. [35] demonstrated that patients’ reports of relief following treatment were often inaccurate. Errors in remembering symptoms increased over longer durations. These results corresponded with those in Santonocito et al. [11] where more than half of the OLP patients felt well, even though the erosive areas had not changed much. Thus, patient’s perception on relief or change after treatment might be less reliable due to the distortions in their memory, compared with measuring OHRQoL at two time points and calculating the change in the score. However, it should be noticed that the difference in OIDP score between the up to moderately improved and greatly improved quality of life groups was marked (17.2 vs. 12.9), while those of the other 3 parameters (highest Thongprasom sign score, total Thongprasom sign score and pain score) were similar. The reason for this is that evaluating quality of life by different instruments should obtain similar results, which agreed with a report that changes in OHIP scores correlated with changes in OHQoL scores after topical corticosteroid treatment [15]. When considering the relationships between the changes in the clinical and patient-based outcomes after 1 month treatment with topical corticosteroids, we found significant relationships for the differences in patient-based outcomes (pain score and OIDP) and the differences in clinical outcomes (highest Thongprasom sign score and total Thongprasom sign scores). These findings were as expected and confirmed the abovementioned discussion on the close relationship between outcomes assessed by different instruments belonging to the same concepts, either clinical or patient-based. Regarding the relationships between the difference in clinical outcomes and the difference in patient-based outcomes, the total Thongprasom sign score better correlated with patient-based outcomes, compared with the highest Thongprasom sign score. A possible explanation might relate to the different impacts from different OLP locations. A study reported that OLP occurring at different locations cause different degrees of symptoms, minor symptoms could be expected for lesions occurring at the buccal/labial mucosa, gingiva and palate, while the symptoms could be greater for tongue lesions [9]. In our study, many patients experienced multiple lesions because the sum of the location percentages was much higher than 100. The assessment of the patient-based outcomes was for a person whose perception was derived from all the existing lesions, while lesions located at different locations cause different impacts. Therefore, the total Thongprasom sign score conceptually corresponds to the patient-based outcome assessment. This might explain the better relationship of the total Thongprasom sign score with the patient-based outcomes than the highest Thongprasom sign score as found in our study Our study’s weak point was the various types and forms of topical corticosteroids with different potencies used in the clinic. Most of our patients received 0.1% fluocinolone acetonide in orabase and 0.05% dexamethasone mouthwash for treating OLP. Thongprasom et al. [5] compared the efficacy of 0.1% fluocinolone acetonide in orabase versus 0.1% triamcinolone acetonide in orabase and found that the clinical OLP improvement in the 0.1% fluocinolone acetonide in orabase treatment group was better than the 0.1% triamcinolone acetonide in orabase treatment group after 4 weeks. Several clinical trials demonstrated that the OLP treatment response from topical corticosteroids in various types and forms relieved pain or burning sensation and reduced the extent and severity of the OLP [8, 10, 11]. Although the clinical and patient-based outcomes from using these topical corticosteroids demonstrated improvements, many previous clinical trials found that each type and concentration of each corticosteroid can result in different clinical outcomes [5, 6, 10, 14, 16]. These factors may impact the relationship between the clinical outcomes and patient-based outcomes. Another weak point was the different characteristics of the patients in this study, such as age, sex, duration of OLP and experience in OLP treatment. Moreover, different numbers and locations of OLP in the oral cavity may have impacted the patient-based results and relationship between the clinical outcomes and patient-based outcomes as discussed above. Additional studies using a larger sample size would allow for the multivariate analysis of which confounding factors could be adjusted to get a better understanding of the clinical and patient-based outcomes in OLP treatment. Conclusion After a 1-month OLP treatment with topical corticosteroids, the highest Thongprasom sign score, total Thongprasom sign score, and pain score were significantly reduced. The patients’ overall OHRQoL and daily performances were significantly improved, except for Relaxing including sleeping of which none of the patients reported a problem before treatment. The differences in the clinical and patient-based outcomes in the group reporting up to moderately improved did not significantly differ from those in the group reporting a greatly improved quality of life. There were significant relationships between the improvement in two clinical outcomes and the improvement in two patient-based outcomes. The decrease in the total Thongprasom sign score was also significantly related to the improvement in OHRQoL. Abbreviations OLP Oral lichen planus NRS Numeric rating scale VAS Visual analog scale OHRQoL Oral-Health-Related Quality of Life OHIP Oral Health Impact Profile OHQoL Oral Health-Related Quality of Life COMDQ Chronic Oral Mucosal Disease Questionnaire OIDP Oral Impact on Daily Performances Index OLDR Oral lichenoid drug reaction ICC Intraclass correlation coefficient PGIC Patient Global Impression of Change Declarations Acknowledgements The authors thank the participants in this study. We appreciate the staff of the Department of Oral Medicine and the Research Unit in Oral Diseases, Faculty of Dentistry, Chulalongkorn University for their assistance. We also express our thanks to Dr. Kevin Tompkins for English language editing. Authors’ contributions PP, SK contributed to the study conception and design, methodology, project administration, supervision, and writing-review & re-editing. WK contributed to the data collection, formal analysis and interpretation of the data, and writing-original draft. PP contributed in the funding acquisition. All authors read and approved the final manuscript. Funding This research was supported by the Faculty Research grant (DRF 65043), Faculty of Dentistry, Chulalongkorn University and the Royal College of Dental Surgeons of Thailand grant. Availability of data and materials All data generated or analyzed during this study are included in this published article. Ethics approval and consent to participate The present study was performed with informed consent following protocols approved by the Human Research Ethics Committee of the Faculty of Dentistry, Chulalongkorn University (certificate number HREC-DCU 2021-090 approved on 3 December 2021). All methods were performed in accordance with the Declaration of Helsinki. Consent for publication Not applicable. Competing interests The authors declare no competing interests. Author details 1 Maharat Nakhon Ratchasima Hospital, Nakhon Ratchasima 30000, Thailand. 2 Department of Oral Medicine, Chulalongkorn University, Bangkok 10330, Thailand. 3 Research Unit in Oral Diseases, Chulalongkorn University, Bangkok 10330, Thailand. 4 Dental Public Health Researcher (Freelance), Bangkok, Thailand. References Lodi G, Scully C, Carrozzo M, Griffiths M, Sugerman PB, Thongprasom K. Current controversies in oral lichen planus: report of an international consensus meeting. Part 2. Clinical management and malignant transformation. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005;100(2):164–78. https://doi.org/10.1016/j.tripleo.2004.06.076 . Lodi G, Scully C, Carrozzo M, Griffiths M, Sugerman PB, Thongprasom K. Current controversies in oral lichen planus: report of an international consensus meeting. Part 1. Viral infections and etiopathogenesis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005;100(1):40–51. https://doi.org/10.1016/j.tripleo.2004.06.077 . Gorouhi F, Davari P, Fazel N. Cutaneous and mucosal lichen planus: a comprehensive review of clinical subtypes, risk factors, diagnosis, and prognosis. Sci World J. 2014;742826. https://doi.org/10.1155/2014/742826 . Eisen D, Carrozzo M, Bagan Sebastian JV, Thongprasom K. Number V Oral lichen planus: clinical features and management. Oral Dis. 2005;11(6):338–49. https://doi.org/10.1111/j.1601-0825.2005.01142.x . Thongprasom K, Luangjarmekorn L, Sererat T, Taweesap W. Relative efficacy of fluocinolone acetonide compared with triamcinolone acetonide in treatment of oral lichen planus. J Oral Pathol Med. 1992;21(10):456–8. https://doi.org/10.1111/j.1600-0714.1992.tb00974.x . Hambly JL, Haywood A, Hattingh L, Nair RG. Comparison between self-formulation and compounded‐formulation dexamethasone mouth rinse for oral lichen planus: a pilot, randomized, cross‐over trial. J Investig Clin Dent. 2017;8(3):e12225. https://doi.org/10.1111/jicd.12225 . García-Pola MJ, González-Álvarez L, Garcia-Martin JM. Treatment of oral lichen planus. Systematic review and therapeutic guide. Med Clin (Barc). 2017;149(8):351–62. https://doi.org/10.1016/j.medcli.2017.06.024 . Escudier M, Ahmed N, Shirlaw P, Setterfield J, Tappuni A, Black M, Challacombe S. A scoring system for mucosal disease severity with special reference to oral lichen planus. Br J Dermatol. 2007;157(4):765–70. https://doi.org/10.1111/j.1365-2133.2007.08106.x . Chainani-Wu N, Silverman S Jr, Reingold A, Bostrom A, Lozada-Nur F, Weintraub J. Validation of instruments to measure the symptoms and signs of oral lichen planus. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008;105(1):51–8. https://doi.org/10.1016/j.tripleo.2007.06.022 . Buajeeb W, Pobrurksa C, Kraivaphan P. Efficacy of fluocinolone acetonide gel in the treatment of oral lichen planus. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000;89(1):42–5. https://doi.org/10.1016/S1079-2104(00)80012-8 . Santonocito S, Polizzi A, De Pasquale R, Ronsivalle V, Lo Giudice A, Isola G. Analysis of the efficacy of two treatment protocols for patients with symptomatic oral lichen planus: A randomized clinical trial. Int J Environ Res Public Health. 2021;18(1):56. https://doi.org/10.3390/ijerph18010056 . Gabriella D, Klemens R, Xiao-Hui R-F, Corinna B, Eva H. Effect of personality traits on the oral health-related quality of life in patients with oral lichen planus undergoing treatment. Clin Oral Invest. 2021;25:2381–9. https://doi.org/10.1007/s00784-020-03561-5 . Riordain RN, Meaney S, McCreary C. A patient-centered approach to developing a quality-of-life questionnaire for chronic oral mucosal diseases. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011;111(5):578–586e572. https://doi.org/10.1016/j.tripleo.2010.12.011 . Brennan MT, Madsen LS, Saunders DP, Napenas JJ, McCreary C, Ni Riordain R, Pedersen AML, Fedele S, Cook RJ, Abdelsayed R. Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus: A phase 2 randomized clinical trial. J Oral Pathol Med. 2022;51(1):86–97. https://doi.org/10.1111/jop.13270 . McGrath C, Hegarty A, Hodgson T, Porter S. Patient-centred outcome measures for oral mucosal disease are sensitive to treatment. Int J Oral Maxillofac Surg. 2003;32(3):334–6. https://doi.org/10.1054/ijom.2002.0377 . Hegarty A, Hodgson T, Lewsey J, Porter S. Fluticasone propionate spray and betamethasone sodium phosphate mouthrinse: a randomized crossover study for the treatment of symptomatic oral lichen planus. J Am Acad Dermatol. 2002;47(2):271–9. Llewellyn CD, Warnakulasuriya S. The impact of stomatological disease on oral health-related quality of life. Eur J Oral Sci. 2003;111(4):297–304. https://doi.org/10.1034/j.1600-0722.2003.00057.x . Wiriyakijja P, Fedele S, Porter SR, Mercadante V, Ni Riordain R. Patient-reported outcome measures in oral lichen planus: A comprehensive review of the literature with focus on psychometric properties and interpretability. J Oral Pathol Med. 2018;47(3):228–39. https://doi.org/10.1111/jop.12604 . Adulyanon S. Oral impacts on daily performances. Measuring Oral Health and Quality of Life. 1997. pp.151–60. Costa AA, Cota LOM, Mendes VS, Oliveira AMSD, Cyrino RM, Costa FO. Impact of oral lesions on the quality of life of psoriatic individuals: A case–control study. 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J Oral Maxillofac Surg Med Pathol. 2016;28(6):488–92. https://doi.org/10.1016/j.ajoms.2016.06.002 . Limpuangthip N, Somkotra T, Arksornnukit M. Impacts of denture retention and stability on oral health-related quality of life, general health, and happiness in elderly Thais. Curr Gerontol Geriatr. 2019;3830267. https://doi.org/10.1155/2019/3830267 . Krisdapong S, Sheiham A, Tsakos G. Impacts of recurrent aphthous stomatitis on quality of life of 12-and 15-year-old Thai children. Qual Life Res. 2012;21:71–6. https://doi.org/10.1007/s11136-011-9925-4 . Yiemstan S, Krisdapong S, Piboonratanakit P. Association between clinical signs of oral lichen planus and oral health-related quality of life: A preliminary study. Dent J. 2020;8(4):113. https://doi.org/10.3390/dj8040113 . Rotaru DI, Sofineti D, Bolboacă SD, Bulboacă AE. Diagnostic criteria of oral lichen planus: A narrative review. Acta Clin Croat. 2020;59(3):513. https://doi.org/10.20471/acc.2020.59.03.16 . Breivik H, Borchgrevink P-C, Allen S-M, Rosseland L-A, Romundstad L, Breivik Hals E, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008;101(1):17–24. https://doi.org/10.1093/bja/aen103 . Scott W, McCracken LM. Patients' impression of change following treatment for chronic pain: global, specific, a single dimension, or many? J Pain. 2015;16(6):518–26. https://doi.org/10.1016/j.jpain.2015.02.007 . Chiang C-P, Chang JY-F, Wang Y-P, Wu Y-H, Lu S-Y, Sun A. Oral lichen planus–differential diagnoses, serum autoantibodies, hematinic deficiencies, and management. J Formos Med Assoc. 2018;117(9):756–65. https://doi.org/10.1016/j.jfma.2018.01.021 . Al-Hashimi I, Schifter M, Lockhart PB, Wray D, Brennan M, Migliorati CA, Axéll T, Bruce AJ, Carpenter W, Eisenberg E. Oral lichen planus and oral lichenoid lesions: diagnostic and therapeutic considerations. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007;103. https://doi.org/10.1016/j.tripleo.2006.11.001 . :S25. e21-S25. e12. Buajeeb W, Kraivaphan P, Pobrurksa C. Efficacy of topical retinoic acid compared with topical fluocinolone acetonide in the treatment of oral lichen planus. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997;83(1):21–5. https://doi.org/10.1016/S1079-2104(97)90085-8 . Gonzalez-Moles M, Bravo M, Gonzalez‐Ruiz L, Ramos P, Gil‐Montoya J. Outcomes of oral lichen planus and oral lichenoid lesions treated with topical corticosteroid. Oral Dis. 2018;24(4):573–9. https://doi.org/10.1111/odi.12803 . Feine JS, Lavigne GJ, Dao TT, Morin C, Lund JP. Memories of chronic pain and perceptions of relief. Pain. 1998;77(2):137–41. https://doi.org/10.1016/S0304-3959(98)00089-X . Tables Table 1. Baseline characteristics and clinical data of the OLP patients (N = 72). Characteristics N (%) Sex Women Men 59 (81.9) 13 (18.1) Age Mean ± SD: 53.3 ± 12.4 years Range: 22–81 years Less than 30 years 30–60 years More than 60 years 3 (4.2) 46 (63.9) 23 (31.9) Duration Mean ± SD: 21.3 ± 30.1 months Range: 1–120 months Less than one year 1–3 years More than three years 51 (70.8) 14 (19.4) 7 (9.8) Systemic condition None Dyslipidemia Hypertension Diabetes mellitus Thyroid disease Gout 40 (55.6) 22 (30.6) 20 (27.8) 9 (12.5) 4 (5.6) 2 (2.8) Medication taking None Anti-dyslipidemia drugs Anti-hypertensive drugs Anti-diabetic drugs Levothyroxine Allopurinol 40 (55.6) 22 (30.6) 27 (37.5) 13 (18.1) 4 (5.6) 2 (2.8) Chief complaint Burning sensation Ulceration Roughness No symptoms 58 (80.6) 47 (65.3) 14 (19.4) 1 (1.4) Experienced about OLP treatment New patients Follow-up patients 60 (83.3) 12 (16.7) Locations Lips Labial mucosa Buccal mucosa Gingiva Tongue Floor of mouth Palate 12 (16.7) 4 (5.6) 58 (80.6) 55 (76.4) 13 (18.1) 8 (11.1) 5 (6.9) Topical corticosteroids treated 0.1% Fluocinolone acetonide in orabase 0.05% Clobetasol propionate in orabase 0.05% Dexamethasone mouthwash 0.1 % Triamcinolone mouthwash 0.05% Fluocinolone mouthwash 0.1% Fluocinolone solution 27 (37.5) 2 (2.8) 23 (31.9) 12 (16.6) 11 (15.3) 1 (1.4) Table 2 . Comparison of the highest Thongprasom sign score, total Thongprasom sign score, pain score, and total OIDP percentage score outcomes between baseline and 1-month follow-up visit (N = 72). Index Mean ± SD (range) Baseline Follow-up Differences a Highest Thongprasom sign score 3.9 ± 2.9 (2 - 5) 2.1 ± 0.8 c (1 - 4) 1.1 ± 0.8 (-1 - 3) Total Thongprasom sign score 13.7 ± 6.8 (2 - 30) 8.7 ± 5.2 b (0 - 26) 5.2 ± 4.1 (-1 - 16) Pain score 6.7 ± 2.6 (0 - 10) 2.9 ± 2.2 b (0 - 10) 3.8 ± 2.5 (0 - 10) Total OIDP percentage score 19.1 ± 10.5 (1.5 - 48) 3.9 ± 4.8 c (0 - 31) 15.2 ± 8.9 (1.5 - 47) a Subtracted the follow-up data from baseline data and sharing with each n. Negative values represented a worsened effect, whereas positive values represented an improved effect. b Statistically significant, compared with baseline, at P <0.01 (paired t-test). c Statistically significant, compared with baseline, at P <0.01 (Wilcoxon signed-rank test). Table 3. Comparison of each performances’ outcomes between baseline and 1-month follow-up visit (N = 72). Performance N (%) Performance score Mean ± SD (range) Baseline Follow-up Differences a Eating 62 (86.1) 14.6 ± 6.1 (1 - 25) 3.9 ± 4.3 c (0 - 20) 11.0 ± 6.3 (0 - 20) Speaking 9 (12.5) 7.4 ± 6.9 (0 - 20) 1.3 ± 2.8 b (0 - 8) 6.1 ± 7.6 (-8 - 16) Cleaning 47 (65.3) 12.5 ± 6.1 (1 - 20) 1.0 ± 2.6 c (0 - 16) 11.5 ± 6.0 (1 - 20) Relaxing 0 0 0 0 Smiling 9 (12.5) 11.4 ± 6.4 (1 - 20) 1.9 ± 2.9 b (0 - 9) 9.9 ± 6.4 (1 - 20) Emotional stability 68 (94.4) 13.6 ± 7.5 (2 - 25) 3.3 ± 4.6 c (0 - 20) 10.1 ± 7.3 (-2 - 25) Working 10 (13.9) 5.4 ± 4.3 (2 - 16) 1.9 ± 2.8 b (0 - 9) 3.5 ± 2.4 (0 - 8) Social contact 15 (20.8) 7.0 ± 6.2 (2 - 25) 2.9 ± 1.7 b (0 - 6) 6.1 ± 4.8 (0 - 25) a Subtracted the follow-up data from baseline data and sharing with each n. Negative values represented a worsened effect, whereas positive values represented an improved effect. b Statistically significant, compared with baseline, at P <0.05 (Wilcoxon signed-rank test). c Statistically significant, compared with baseline, at P <0.01 (Wilcoxon signed-rank test). Table 4 . Comparison of the differences in clinical and patient-based outcomes between groups of patients who reported up to moderately improved and greatly improved (N = 72). Differences Differences a Mean ± SD (range) P value c Up to moderately improved b (N = 33) Greatly improved (N = 39) Highest Thongprasom sign score 1.1 ± 0.6 (0 - 3) 1.2 ± 0.8 (0 - 3) 0.528 Total Thongprasom sign score 5.3 ± 3.5 (0 - 12) 5.3 ± 4.7 (-1 - 16) 0.820 Pain score 3.4 ± 2.6 (1 - 10) 4.1 ± 2.4 (1 - 10) 0.233 Total OIDP percentage score 12.9 ± 7.0 (1.5 – 31.5) 17.2 ± 10.0 (4.5 - 47) 0.079 a Subtracted the follow-up data from baseline data and sharing with each n. Negative values represented a worsened effect, whereas positive values represented an improved effect. b Including 1 no changes, 4 minimally improved and 28 moderately improved patients. c Statistically analyzed with Mann-Whitney U test. Table 5. Relationships of the differences among the total OIDP percentage score, highest Thongprasom sign score, total Thongprasom sign score and pain score. Differences Differences Total Thongprasom score Pain score OIDP r P value r P value r P value Highest Thongprasom sign score 0.293 0.012 a 0.109 0.362 0.198 0.096 Total Thongprasom sign score - 0.118 0.324 0.335 0.004 b Pain score - - 0.427 <0.001 c a Statistically significant at P <0.05 (Pearson’s correlation). b Statistically significant at P <0.01 (Pearson’s correlation). c Statistically significant at P <0.001 (Pearson’s correlation). Additional Declarations No competing interests reported. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3153939","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":223293552,"identity":"a68993a4-35eb-4d42-b842-3c29304e4bcc","order_by":0,"name":"Witchapat Kengtong","email":"","orcid":"","institution":"Maharat Nakhon Ratchasima Hospital","correspondingAuthor":false,"prefix":"","firstName":"Witchapat","middleName":"","lastName":"Kengtong","suffix":""},{"id":223293553,"identity":"63d21be3-d04b-49e5-9434-3a215a3d9213","order_by":1,"name":"Pornpan Piboonratanakit","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA4UlEQVRIie3RsQrCMBCA4StCspy4Vgr1FU4EQxefRRE6OXQUFFQEXaqzog9TCNilD1DRrdDJTXAUUxXcYkfB/NMR7oOEAJhMPx2fMoDgNVfKEYwUoedozcsRu1uSCL7Ks2B8BlHP8gypA7VlxLNAQ7wwFq3NIQdv54sWUh/spGvNNxpCqc8cZBLoNFADqYen6mL4ldwVOSYFmUCjFKkuFEmxIMXwhXjhgTnbtUQv9Nv1PcXYTHqznY4IvmBOcJOu4DK3L8OR68YyumovBq+/RnofqGVrqgEfAqRdM5lMpr/uAT1ZQC9jj9/IAAAAAElFTkSuQmCC","orcid":"","institution":"Chulalongkorn University","correspondingAuthor":true,"prefix":"","firstName":"Pornpan","middleName":"","lastName":"Piboonratanakit","suffix":""},{"id":223293554,"identity":"84871bba-9c53-4c86-a818-af0f1667909a","order_by":2,"name":"Sudaduang Krisdapong","email":"","orcid":"","institution":"Dental Public Health Researcher (Freelance)","correspondingAuthor":false,"prefix":"","firstName":"Sudaduang","middleName":"","lastName":"Krisdapong","suffix":""}],"badges":[],"createdAt":"2023-07-09 13:59:22","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3153939/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3153939/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12903-023-03603-w","type":"published","date":"2023-11-21T15:01:27+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":47146750,"identity":"1a474e33-6f14-43a7-97a2-70eaacca3c7c","added_by":"auto","created_at":"2023-11-27 15:09:10","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":432249,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3153939/v1/fab7090f-f358-425d-93fb-a7c22a85cb0c.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Changes in the Oral-Health-Related Quality of Life of Thai patients with oral lichen planus after topical corticosteroid treatment: a 1-month longitudinal study","fulltext":[{"header":"Background","content":"\u003cp\u003eOral lichen planus (OLP) is a common chronic inflammatory disease of the oral cavity that affects the daily living activities in many patients. Most OLP patients are middle-aged women; the most common lesion sites are the buccal mucosa followed by the tongue, and gingiva [1]. OLP occurs in several forms, with the classic forms being white lesions presenting as reticular, papular, or plaque-like patterns and red lesions presenting as atrophic and ulcerative areas [2]. The main symptoms of OLP are a burning sensation when eating hot and spicy foods or severe chronic pain in the oral cavity [3]. The goal of treating OLP is to relieve symptomatic pain and reduce inflammation. The first-line drugs for treating OLP are corticosteroids taken in topical forms that can be used in various types and preparations, such as fluocinolone acetonide oral paste and dexamethasone mouthwash [4\u0026ndash;6]. The advantages of topical corticosteroids are the lower risk of systemic steroid effects, such as hypertension, gastric ulcers, bone mineral loss, or adrenal suppression, however, they have an increased risk of oral candidiasis when used over a prolonged period [7].\u003c/p\u003e \u003cp\u003eCurrently, OLP clinical trials should use a tripartite approach comprising clinical signs, symptoms, and quality of life [8]. Chainani-Wu et al. [9] recommended using an instrument that was sensitive and easy to apply when evaluating the signs of OLP. For clinical evaluation, several OLP studies applied the Thongprasom sign scoring system [5, 10\u0026ndash;12]. This scoring system takes the size and clinical severity of each OLP lesion into account, however, only the highest score is assigned for a patient regardless of the number of lesions. Unlike the Thongprasom sign scoring system, some systems take into account the number of lesions and the severity of each lesion [8, 9].\u003c/p\u003e \u003cp\u003eBecause OLP was a chronic inflammatory disease that is very difficult to completely cure, patients suffer from a burning sensation, pain, and discomfort [13]. Pain rating scales, e.g. numeric rating scale (NRS) and visual analog scale (VAS), are widely accepted and are more useful for assessing OLP symptoms [9]. Several OLP longitudinal studies used these scales for assessing OLP symptoms [11, 14\u0026ndash;16]. Moreover, the concept of patient-based outcome measures has been used to determine impaired oral health from the patient's perspective using the Oral-Health-Related Quality of Life (OHRQoL) [17]. These perspectives can be measured by several indices, such as the Oral Health Impact Profile (OHIP), Oral Health-related Quality of Life (OHQoL) and Chronic Oral Mucosal Disease Questionnaire (COMDQ) [18]. Several OLP longitudinal studies chose OHIP or OHQoL as instruments to determine the patient-centered outcomes along with the efficacy of the drugs after treatment [12, 15, 16]. Furthermore, COMDQ was one of the measurements used in a phase II study of clobetasol patches for treating OLP [14].\u003c/p\u003e \u003cp\u003eThe Oral Impact on Daily Performances Index (OIDP) [19] is another OHRQoL measure developed to assess the ultimate impacts, i.e. difficulties in daily life performances that are the consequences of intermediate impacts, e.g. pain, discomfort, functional limitations, and dissatisfaction with appearance, thus, avoiding repetition in measuring the impacts. If pain as the intermediate impact leads to difficulty in eating as the ultimate impact, OIDP will consider only difficulty in eating. In oral medicine, OIDP was used to assess the oral impacts attributed to angular cheilitis, and geographic tongue in the Portuguese version [20]. The Arabic OIDP version was applied to assess the relationship between OHRQoL and oral lesions related to skin lesions [21]. In Thailand, this index has been validated in all age groups and widely applied in several dental specialties\u0026rsquo; clinical research and in Thailand national health surveys [22\u0026ndash;25]. There was also an investigation of OHRQoL attributed to recurrent aphthous stomatitis in Thai children in a national oral health survey using OIDP [26]. Yiemstan et al. [27] also used the Thai OIDP version for investigating the associations of OHRQoL and pain with clinical signs based on the Thongprasom sign scoring system in OLP patients.\u003c/p\u003e \u003cp\u003eThe previous studies about oral mucosal lesions that used OIDP were cross-sectional and case-control studies, whereas most OLP longitudinal studies used OHIP and OHQoL for OHRQoL evaluation. None of the OLP longitudinal studies used OIDP to measure OHRQoL. Therefore, the aim of this study was to evaluate the clinical, pain and OHRQoL responses after a 1-month treatment with topical corticosteroid in OLP patients. Secondly, to assess the relationships of the changes in the clinical sign score, pain score, and OHRQoL.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy subjects\u003c/h2\u003e \u003cp\u003eThe sample size was calculated using 80% power and 95% confidence level according to data from McGrath et al. [15]. They assessed the OHRQoL in patients with OLP treated with topical betamethasone using OHQoL-UK and OHIP-14 questionnaires. The effect size (ρ) was 0.31, thus, the estimated total sample size was 66. To compensate for error or loss of participants during follow up, the sample size was increased by 10%, resulting in 72 patients.\u003c/p\u003e \u003cp\u003eThe patients were recruited from the Oral Medicine clinic, Faculty of Dentistry, Chulalongkorn University. The inclusion criteria were being over 18 years old, patients diagnosed with OLP or compatible with OLP following clinical and histopathological criteria [28], oral lichenoid drug reaction (OLDR) patients with a history of taking a related medication, patients receiving topical corticosteroid for OLP treatment, follow-up patients requiring follow-up appointment for 1 month, and patients with written informed consent. The exclusion criteria were pregnant patients, patients with a history of smoking within six months, patients who were treated with other modalities or had other types of oral mucosal lesions, or oral lichenoid contact lesion patients. The interviewer was trained and calibrated with an expert in using the OIDP index. The inter-rater agreement was good with an intraclass correlation coefficient (ICC) of 0.877.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cdiv id=\"Sec5\" class=\"Section3\"\u003e \u003ch2\u003eDemographic data\u003c/h2\u003e \u003cp\u003eAge, sex, systemic condition, medication taking and OLP duration since the first diagnosis were collected from the history taking at the first visit. In addition, the OLP locations (e.g. lips, labial mucosa, buccal mucosa, gingiva, tongue, floor of the mouth, and palate), experience with OLP treatment (i.e., new or follow-up patient) and prescribed topical corticosteroids were also recorded.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eClinical outcomes\u003c/h2\u003e \u003cp\u003eRegarding the clinical data collection, the highest Thongprasom sign score was based on the original Thongprasom sign scoring system, i.e., \"0\" indicated no lesions; \"1\" indicated white striae only, \"2\" indicated white striae with an atrophic area of less than 1 cm\u003csup\u003e2\u003c/sup\u003e, \"3\" indicated white striae with an atrophic area of 1 cm\u003csup\u003e2\u003c/sup\u003e or more, \"4\" indicated white striae with an erosive area of less than 1 cm\u003csup\u003e2\u003c/sup\u003e and \"5\" indicated white striae with an erosive area of 1 cm\u003csup\u003e2\u003c/sup\u003e or more (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). The highest Thongprasom sign score obtained from the most severe lesion ranging from 0\u0026ndash;5, was assigned to the patient.\u003c/p\u003e \u003cp\u003eThe total Thongprasom sign score, which was the sum of all lesions\u0026rsquo; Thongprasom sign scores, was calculated. The OLP distribution was recorded as the outer and inner lips, right and left buccal mucosa, upper right, upper central, upper left, lower left, lower central, and lower right gingiva, dorsal, left and right ventrolateral tongue, floor of the mouth, hard palate, and soft palate [9]. Because the possible maximum number of OLP oral lesions was 16, the total Thongprasom sign scores ranged from 0\u0026ndash;80. The highest and total Thongprasom sign scores were recorded at baseline and the follow-up visit\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003ePatient-based outcomes\u003c/h2\u003e \u003cp\u003eThe patients were asked about the chief symptoms of OLP that made them visit the dentist at baseline, such as a burning sensation, ulceration, and roughness. The patients could have more than 1 symptom or have no symptoms. In the aspect of pain, the OLP patients reported their NRS score for their worst pain during 1 month at baseline and the follow-up visit [29], ranging from 0\u0026ndash;10: \"0\" meant no pain at all, and \"10\" meant the worst pain imaginable.\u003c/p\u003e \u003cp\u003eThe patients\u0026rsquo; OHRQoL was assessed using the Thai version of the OIDP [22]. The patients were asked about the OLP that limited their eight daily activities at baseline and the 1-month follow-up visit. The eight activities consisted of Eating, Speaking, Cleaning the oral cavity, Relaxing including sleeping, Smiling, laughing without embarrassment, Emotional stability, Carrying out major work and Social contact. The frequency and severity scores of difficulties, if any, on performing each activity were recorded. Due to the chronic nature of OLP, frequency scores on a regular basis was used: \"0\" meant never affected, \"1\" meant once a month, \"2\" meant twice a month, \"3\" meant once or twice a week \"4\" meant three to four times a week and \"5\" meant every or almost every day. The severity scores were scored as: \"0\" meant never affected daily life, \"1\" meant very low impact, \"2\" meant low impact, \"3\" meant moderate impact, \"4\" meant high impact, and \"5\" meant very high impact. The frequency and severity scores of difficulties on performing each activity were multiplied, resulting in a performance score ranging from 0\u0026ndash;25. The sum of the eight performance scores ranging from 0\u0026ndash;200 was divided by 2 to get a total OIDP percentage score ranging from 0\u0026ndash;100. The higher scores indicated a poorer OHRQoL [19].\u003c/p\u003e \u003cp\u003eAt the 1-month follow-up visit, the differences in each outcome were calculated by subtracting the follow-up data from the baseline data. Negative values represented a worsened effect, whereas positive values represented an improved effect. The differences in the mean values were determined. In addition, the OLP patients were asked to self-rate the overall changes in quality of life during the 4-week treatment period. The rating criteria from the Patient Global Impression of Change (PGIC) measure [30] were used. The PGIC was categorized on a 7-point scale as \"severely worsened\", \"moderately worsened\", \"minimally worsened\", \"no change\", \"minimally improved\", \"moderately improved\", and \"greatly improved\u0026rdquo;.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eData analysis\u003c/h2\u003e \u003cp\u003eStatistical calculations were performed with SPSS software (SPSS 22.0 for Windows; SPSS, Chicago, IL, USA). Descriptive statistics were used for the demographic and clinical data. The Kolomogonov-Smirnov normality tests were performed to determine the normal data distribution in each outcome. The pain score and total Thongprasom sign score between baseline and after the 1-month treatment were assessed using the paired t-test. The highest Thongprasom sign score, total OIDP percentage score, and performance scores of each daily activity between baseline and after the 1-month treatment were analyzed by the Wilcoxon signed-rank test. The differences in the highest Thongprasom sign score, total Thongprasom sign score, pain score and total OIDP percentage score between two groups of patients who reported no changes to moderately-improved and greatly-improved PGIC were tested using the Mann-Whitney U test. Pearson\u0026rsquo;s correlation was used to assess the relationship between the differences in the total OIDP percentage score, highest Thongprasom sign score, total Thongprasom sign score and pain score. The significance level was set at \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003eOLP patient characteristics\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe 72 patients (100% response rate) in this study consisted of 59 women (81.9%) and 13 men (18.1%). The mean age of the patients in this study was 53.3 \u0026plusmn; 12.4 years old (range 22\u0026ndash;81 years old). Forty-six patients (63.9%) were between 30 and 60 years old. Twenty-three patients (31.9%) were more than 60 years old and 3 patients (4.2%) were less than 30 years old. Sixty patients (83.3%) in this study were new patients and 12 patients (16.7%) were follow-up patients. (Table 1.) \u003c/p\u003e\n\u003cp\u003eConcerning the patients\u0026rsquo; systemic condition, 40 patients (55.6%) reported no medical problems and were not taking any medications. Twenty-two patients (30.6%) were diagnosed with dyslipidemia and took anti-dyslipidemia drugs. Furthermore, 20 (27.8%) of the patients had hypertension and 9 (12.5%) had diabetes mellitus. Both diseases can require more than one group of drugs to treat them as 27 drugs (37.5%) for hypertension patients and 13 drugs (18.1%) for diabetic patients were reported. There were also 4 patients (5.6%) with thyroid disease and 2 patients (2.8%) with gout taking levothyroxine and allopurinol, respectively. (Table 1.)\u003c/p\u003e\n\u003cp\u003eFifty-one patients (70.8%) had their OLP less than 1 year before seeing the dentist, however, 14 patients (19.4%) were diagnosed 1\u0026ndash;3 years earlier. Seven patients (9.8%) had their lesions for more than 3 years. The mean duration of OLP was 21.3 \u0026plusmn; 30.1 months (range 1\u0026ndash;120 months). OLP occurred in various sites in the oral cavity, with the most commonly afflicted area being the buccal mucosa (80.6%) followed by gingiva (76.4%), tongue (18.1%), lips (16.7%), and floor of the mouth (11.1%). Less than 10% of the patients demonstrated OLP at the palate (6.9%) and labial mucosa (5.6%). (Table 1.)\u003c/p\u003e\n\u003cp\u003eThe most frequently prescribed topical corticosteroids were 0.1% fluocinolone acetonide in orabase (37.5%), followed by 0.05% dexamethasone mouthwash (31.9%), 0.1% triamcinolone mouthwash (16.6%) and 0.05% fluocinolone mouthwash (15.3%). Other topical corticosteroids, 0.05% clobetasol propionate in orabase (2.8%) and 0.1% fluocinolone solution (1.4%), were infrequently prescribed. (Table 1.)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical and \u003c/strong\u003e\u003cstrong\u003epatient-based outcomes at baseline\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSome patients reported more than one complaint at the first visit. Common patients\u0026rsquo; chief complaints were a burning sensation in the oral cavity (80.6%), having an ulceration (65.3%), and a rough oral mucosal surface (19.4%), however, 1 patient had no symptoms (1.4%). (Table 1.) At baseline, the average highest Thongprasom sign score was 3.9 \u0026plusmn; 2.9 (range 2\u0026ndash;5) and the average total Thongprasom sign score was 13.7 \u0026plusmn; 6.8 (range 2\u0026ndash;30). (Table 2.)\u003c/p\u003e\n\u003cp\u003eAt baseline, the mean pain score was 6.7 \u0026plusmn; 2.6 (range 0\u0026ndash;10) and the total OIDP percentage score was 19.1 \u0026plusmn; 10.5 (range 1.5\u0026ndash;48). (Table 2.) The three most commonly affected activities were Emotional stability (94.4%), Eating (86.1%) and Cleaning the oral cavity (65.3%). Fewer patients had problems in Social contact (20.8%), Carrying out major work (13.9%), Speaking (12.5%) and Smiling, laughing without embarrassment (12.5%). No patient reported relaxing disturbance due to OLP. (Table 3.) At baseline, the activity with the highest performance score was Eating (mean \u0026plusmn; SD; 14.6 \u0026plusmn; 6.1), followed by Emotional stability (mean \u0026plusmn; SD; 13.6 \u0026plusmn; 7.5), Cleaning the oral cavity (mean \u0026plusmn; SD; 12.5 \u0026plusmn; 6.1), and Smiling without embarrassment (mean \u0026plusmn; SD; 11.4 \u0026plusmn; 6.4). The performance scores of 3 other activities, i.e., Speaking, Social contact, and Carrying out major work, were less than 10. (Table 3.) \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical and \u003c/strong\u003e\u003cstrong\u003epatient-based outcomes after 1-month treatment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAt the 1-month follow-up visit, the mean highest Thongprasom sign score was 2.1 \u0026plusmn; 0.8 (range 1\u0026ndash;4), thus, the difference in score from baseline was 1.1 \u0026plusmn; 0.8 (range -1 to 3). The total Thongprasom sign score was 8.7 \u0026plusmn; 5.2 (range 0\u0026ndash;26), thus, the difference from baseline was 5.2 \u0026plusmn; 4.1 (range-1 to 16). Both clinical outcomes significantly improved after 1-month treatment with topical corticosteroids (\u003cem\u003eP\u003c/em\u003e \u0026lt; 0.01). (Table 2.)At the 1-month follow-up visit, the pain score was 2.9 \u0026plusmn; 2.2 (range 0\u0026ndash;10) and the reduced pain score was 3.8 \u0026plusmn; 2.5 (range 0\u0026ndash;10). The pain score also significantly reduced after 1-month treatment (\u003cem\u003eP\u003c/em\u003e \u0026lt; 0.01). The total OIDP percentage score after 1-month treatment was 3.9 \u0026plusmn; 4.8 (range 0\u0026ndash;31) and its difference in total OIDP percentage score was 15.2 \u0026plusmn; 8.9 (range 1.5\u0026ndash;47), which was significantly lower compared with that at baseline (\u003cem\u003eP\u003c/em\u003e \u0026lt; 0.01). (Table 2.) At the follow-up visit, the OIDP performance scores of Eating (mean \u0026plusmn; SD; 3.9 \u0026plusmn; 4.3), Emotional stability (mean \u0026plusmn; SD; 3.3 \u0026plusmn; 4.6), and Cleaning the oral cavity (mean \u0026plusmn; SD; 1.0 \u0026plusmn; 2.6) were significantly decreased compared with those at baseline (\u003cem\u003eP\u003c/em\u003e \u0026lt; 0.01). In addition, the OIDP performance scores of the other 4 activities; Social contact (mean \u0026plusmn; SD; 2.9 \u0026plusmn; 1.7), Carrying out major work (mean \u0026plusmn; SD; 1.9 \u0026plusmn; 2.8), Speaking (mean \u0026plusmn; SD; 1.3 \u0026plusmn; 2.8), and Smiling, laughing without embarrassment (mean \u0026plusmn; SD; 1.9 \u0026plusmn; 2.9), were also significantly decreased compared with those at baseline (\u003cem\u003eP\u003c/em\u003e \u0026lt; 0.05). (Table 3.)\u003c/p\u003e\n\u003cp\u003eThe differences in the mean of each performance are also presented in Table 3. The mean \u0026plusmn; SD of differences in Cleaning was 11.5 \u0026plusmn; 6.0, followed by Eating (11.0 \u0026plusmn; 6.3), Emotional stability (10.1 \u0026plusmn; 7.3), Smiling without embarrassment (9.9 \u0026plusmn; 6.4), Speaking (6.1 \u0026plusmn; 7.6), Social contact (6.1 \u0026plusmn; 4.8) and Working (3.5 \u0026plusmn; 2.4).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatient global impression of change (PGIC)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAfter 1-month treatment with topical corticosteroid, none of the patients reported severely worsened, moderately worsened or minimally worsened quality of life. One patient (1.4%) reported no changes after treatment. Four patients (5.6%) described themselves as minimally improved, 28 patients (38.9%) felt moderately improved, and 39 patients (54.2%) felt greatly improved. Therefore, we made 2 groups of patients that were the same or up to moderately improved (45.8%) and greatly improved (54.2%) quality of life groups to compare the reduced clinical and patient-based outcomes. The differences in total OIDP percentage score were 12.9 \u0026plusmn; 7.0 in the same or up to moderately improved group and 17.2 \u0026plusmn; 10.0 in the greatly improved group (\u003cem\u003eP\u003c/em\u003e = 0.079). In contrast, the differences in the mean of other outcomes, consisting of the highest Thongprasom sign score, total Thongprasom sign score, and pain scores demonstrated similar values or slight differences between the groups (\u003cem\u003eP\u003c/em\u003e = 0.528, \u003cem\u003eP\u003c/em\u003e = 0.820, and \u003cem\u003eP\u003c/em\u003e = 0.233, respectively). (Table 4.) \u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRelationships between the differences in the mean clinical and patient-based outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe difference in total OIDP percentage score and difference in pain score demonstrated a significant relationship (r = 0.427; \u003cem\u003eP\u003c/em\u003e \u0026lt; 0.001) and the difference in total OIDP percentage score and difference in total Thongprasom sign score was significantly related (r = 0.335; \u003cem\u003eP\u003c/em\u003e \u0026lt; 0.01). There was a significant relationship between the difference in the highest Thongprasom sign score and the difference in total Thongprasom sign score (r = 0.293; \u003cem\u003eP \u003c/em\u003e= 0.012). No significant relationship was found between the difference in the highest Thongprasom sign score and the difference in total OIDP percentage score (r = 0.198; \u003cem\u003eP\u003c/em\u003e = 0.096), or between the differences in the highest Thongprasom sign score or total Thongprasom score and the difference in pain score (r = 0.109; \u003cem\u003eP\u003c/em\u003e = 0.362 and r = 0.118; \u003cem\u003eP\u003c/em\u003e = 0.324, respectively). (Table 5.)\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis was the first longitudinal study to assess OHRQoL using OIDP in patients treated for OLP. Moreover, this was also the first study using a total scoring system based on the Thongprasom sign scoring system for the severity due to OLP. Most of the patients participating in this study benefited from using topical corticosteroids, as demonstrated by the improvement in the clinical and patient-based outcomes. We found that the highest and total Thongprasom sign scores for OLP were significantly decreased after 1-month treatment with topical corticosteroids compared with baseline. Several reviews revealed that topical corticosteroids are clinically effective and are considered the treatment of choice for OLP [31, 32]. Thongprasom et al. [5] found no significant clinical improvement in 2 weeks, however, after 4 weeks, more than 60% of OLP patients who used 0.1% fluocinolone acetonide in orabase had the highest Thongprasom sign score of less than 2. Furthermore, there have been multiple clinical trials supporting that improvement in clinical sign scores and OLP symptoms can be detected after at least 4 weeks [10, 33]. Hegarty et al. [16] found that topical corticosteroids reduced the signs and symptoms of OLP within 3\u0026ndash;4 weeks, thus, these drugs were effective in the early treatment of symptomatic OLP.\u003c/p\u003e \u003cp\u003eOLP affects patient\u0026rsquo;s quality of life, however, effective treatment can improve their ability to perform everyday activities [16]. One of the goals of OLP treatment with topical corticosteroids is to have the patients recover their ability to perform the basic activities of daily life, such as eating, drinking, or tooth brushing [34]. In the present study, the three activities with the highest prevalence were Emotional stability followed by Eating, and Cleaning the oral cavity. The total OIDP percentage score was also significantly decreased. Moreover, all performances, except for Relaxing including sleeping, in which no patient reported difficulty before receiving treatment, improved by more than 80% after 1 month. These results indicate that the OLP patients achieved a better quality of life in every important domain after 1-month treatment with topical corticosteroids. Our results corresponded to those of a previous study in which OLP patients had a significant negative impact on OHIP (e.g. functional limitation, physical disability, physical pain and psychological discomfort) and all these impacts were improved after topical corticosteroid treatment [12]. Previous longitudinal OLP studies using OHIP and OHQoL as OHRQoL assessment tools also found a significant improvement in OHRQoL in OLP patients after treating them with topical corticosteroids by 3\u0026ndash;6 weeks [15, 16]. Hambly et al. [6] reported that their patients could consume spicy foods or felt more confident after using topical corticosteroids to treat their OLP.\u003c/p\u003e \u003cp\u003eThe PGIC, the patients\u0026rsquo; perception on their changing OHRQoL, results revealed that most patients reported improvement in various scales. However, the difference in the reduced clinical, pain and OIDP scores between those reporting up to moderately improved and greatly improved were not significant. Feine et al. [35] demonstrated that patients\u0026rsquo; reports of relief following treatment were often inaccurate. Errors in remembering symptoms increased over longer durations. These results corresponded with those in Santonocito et al. [11] where more than half of the OLP patients felt well, even though the erosive areas had not changed much. Thus, patient\u0026rsquo;s perception on relief or change after treatment might be less reliable due to the distortions in their memory, compared with measuring OHRQoL at two time points and calculating the change in the score. However, it should be noticed that the difference in OIDP score between the up to moderately improved and greatly improved quality of life groups was marked (17.2 vs. 12.9), while those of the other 3 parameters (highest Thongprasom sign score, total Thongprasom sign score and pain score) were similar. The reason for this is that evaluating quality of life by different instruments should obtain similar results, which agreed with a report that changes in OHIP scores correlated with changes in OHQoL scores after topical corticosteroid treatment [15].\u003c/p\u003e \u003cp\u003eWhen considering the relationships between the changes in the clinical and patient-based outcomes after 1 month treatment with topical corticosteroids, we found significant relationships for the differences in patient-based outcomes (pain score and OIDP) and the differences in clinical outcomes (highest Thongprasom sign score and total Thongprasom sign scores). These findings were as expected and confirmed the abovementioned discussion on the close relationship between outcomes assessed by different instruments belonging to the same concepts, either clinical or patient-based. Regarding the relationships between the difference in clinical outcomes and the difference in patient-based outcomes, the total Thongprasom sign score better correlated with patient-based outcomes, compared with the highest Thongprasom sign score. A possible explanation might relate to the different impacts from different OLP locations. A study reported that OLP occurring at different locations cause different degrees of symptoms, minor symptoms could be expected for lesions occurring at the buccal/labial mucosa, gingiva and palate, while the symptoms could be greater for tongue lesions [9]. In our study, many patients experienced multiple lesions because the sum of the location percentages was much higher than 100. The assessment of the patient-based outcomes was for a person whose perception was derived from all the existing lesions, while lesions located at different locations cause different impacts. Therefore, the total Thongprasom sign score conceptually corresponds to the patient-based outcome assessment. This might explain the better relationship of the total Thongprasom sign score with the patient-based outcomes than the highest Thongprasom sign score as found in our study\u003c/p\u003e \u003cp\u003eOur study\u0026rsquo;s weak point was the various types and forms of topical corticosteroids with different potencies used in the clinic. Most of our patients received 0.1% fluocinolone acetonide in orabase and 0.05% dexamethasone mouthwash for treating OLP. Thongprasom et al. [5] compared the efficacy of 0.1% fluocinolone acetonide in orabase versus 0.1% triamcinolone acetonide in orabase and found that the clinical OLP improvement in the 0.1% fluocinolone acetonide in orabase treatment group was better than the 0.1% triamcinolone acetonide in orabase treatment group after 4 weeks. Several clinical trials demonstrated that the OLP treatment response from topical corticosteroids in various types and forms relieved pain or burning sensation and reduced the extent and severity of the OLP [8, 10, 11]. Although the clinical and patient-based outcomes from using these topical corticosteroids demonstrated improvements, many previous clinical trials found that each type and concentration of each corticosteroid can result in different clinical outcomes [5, 6, 10, 14, 16]. These factors may impact the relationship between the clinical outcomes and patient-based outcomes.\u003c/p\u003e \u003cp\u003eAnother weak point was the different characteristics of the patients in this study, such as age, sex, duration of OLP and experience in OLP treatment. Moreover, different numbers and locations of OLP in the oral cavity may have impacted the patient-based results and relationship between the clinical outcomes and patient-based outcomes as discussed above. Additional studies using a larger sample size would allow for the multivariate analysis of which confounding factors could be adjusted to get a better understanding of the clinical and patient-based outcomes in OLP treatment.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eAfter a 1-month OLP treatment with topical corticosteroids, the highest Thongprasom sign score, total Thongprasom sign score, and pain score were significantly reduced. The patients\u0026rsquo; overall OHRQoL and daily performances were significantly improved, except for Relaxing including sleeping of which none of the patients reported a problem before treatment. The differences in the clinical and patient-based outcomes in the group reporting up to moderately improved did not significantly differ from those in the group reporting a greatly improved quality of life. There were significant relationships between the improvement in two clinical outcomes and the improvement in two patient-based outcomes. The decrease in the total Thongprasom sign score was also significantly related to the improvement in OHRQoL.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eOLP Oral lichen planus\u003c/p\u003e\n\u003cp\u003eNRS Numeric rating scale\u003c/p\u003e\n\u003cp\u003eVAS Visual analog scale \u003c/p\u003e\n\u003cp\u003eOHRQoL Oral-Health-Related Quality of Life\u003c/p\u003e\n\u003cp\u003eOHIP Oral Health Impact Profile\u003c/p\u003e\n\u003cp\u003eOHQoL Oral Health-Related Quality of Life \u003c/p\u003e\n\u003cp\u003eCOMDQ Chronic Oral Mucosal Disease Questionnaire\u003c/p\u003e\n\u003cp\u003eOIDP Oral Impact on Daily Performances Index\u003c/p\u003e\n\u003cp\u003eOLDR Oral lichenoid drug reaction\u003c/p\u003e\n\u003cp\u003eICC Intraclass correlation coefficient\u003c/p\u003e\n\u003cp\u003ePGIC Patient Global Impression of Change\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors thank the participants in this study. We appreciate the staff of the Department of Oral Medicine and the Research Unit in Oral Diseases, Faculty of Dentistry, Chulalongkorn University for their assistance. We also express our thanks to Dr. Kevin Tompkins for English language editing.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePP, SK contributed to the study conception and design, methodology, project administration, supervision, and writing-review \u0026amp; re-editing. WK contributed to the data collection, formal analysis and interpretation of the data, and writing-original draft. PP contributed in the funding acquisition. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research was supported by the Faculty Research grant (DRF 65043), Faculty of Dentistry, Chulalongkorn University and the Royal College of Dental Surgeons of Thailand grant.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll data generated or analyzed during this study are included in this published article.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe present study was performed with informed consent following protocols approved by the Human Research Ethics Committee of the Faculty of Dentistry, Chulalongkorn University (certificate number HREC-DCU 2021-090 approved on 3 December 2021). All methods were performed in accordance with the Declaration of Helsinki.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor details\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e1\u003c/sup\u003eMaharat Nakhon Ratchasima Hospital, Nakhon Ratchasima 30000, Thailand.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e2\u003c/sup\u003eDepartment of Oral Medicine, Chulalongkorn University, Bangkok 10330, Thailand.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e3\u003c/sup\u003eResearch Unit in Oral Diseases, Chulalongkorn University, Bangkok 10330, Thailand.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e4\u003c/sup\u003eDental Public Health Researcher (Freelance), Bangkok, Thailand.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eLodi G, Scully C, Carrozzo M, Griffiths M, Sugerman PB, Thongprasom K. 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Memories of chronic pain and perceptions of relief. Pain. 1998;77(2):137\u0026ndash;41. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/S0304-3959(98)00089-X\u003c/span\u003e\u003cspan address=\"10.1016/S0304-3959(98)00089-X\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003e\u003cstrong\u003eTable 1.\u003c/strong\u003e Baseline characteristics and clinical data of the OLP patients (N = 72).\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"62.89517470881864%\" valign=\"top\"\u003e\n \u003cp\u003eCharacteristics\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.10482529118136%\" valign=\"top\"\u003e\n \u003cp\u003eN (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"62.89517470881864%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSex\u003c/strong\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eWomen\u003c/li\u003e\n \u003cli\u003eMen\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.10482529118136%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e59 (81.9)\u003c/p\u003e\n \u003cp\u003e13 (18.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"62.89517470881864%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAge \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Mean \u0026plusmn; SD: 53.3 \u0026plusmn; 12.4 years\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Range: 22\u0026ndash;81 years\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eLess than 30 years\u003c/li\u003e\n \u003cli\u003e30\u0026ndash;60 years\u003c/li\u003e\n \u003cli\u003eMore than 60 years\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.10482529118136%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3 (4.2)\u003c/p\u003e\n \u003cp\u003e46 (63.9)\u003c/p\u003e\n \u003cp\u003e23 (31.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"62.89517470881864%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eDuration\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Mean \u0026plusmn; SD: 21.3 \u0026plusmn; 30.1 months\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Range: 1\u0026ndash;120 months\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eLess than one year\u003c/li\u003e\n \u003cli\u003e1\u0026ndash;3 years\u003c/li\u003e\n \u003cli\u003eMore than three years\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.10482529118136%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e51 (70.8)\u003c/p\u003e\n \u003cp\u003e14 (19.4)\u003c/p\u003e\n \u003cp\u003e7 (9.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"62.89517470881864%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSystemic condition\u003c/strong\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eNone\u003c/li\u003e\n \u003cli\u003eDyslipidemia\u003c/li\u003e\n \u003cli\u003eHypertension\u003c/li\u003e\n \u003cli\u003eDiabetes mellitus\u003c/li\u003e\n \u003cli\u003eThyroid disease\u003c/li\u003e\n \u003cli\u003eGout\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.10482529118136%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e40 (55.6)\u003c/p\u003e\n \u003cp\u003e22 (30.6)\u003c/p\u003e\n \u003cp\u003e20 (27.8)\u003c/p\u003e\n \u003cp\u003e9 (12.5)\u003c/p\u003e\n \u003cp\u003e4 (5.6)\u003c/p\u003e\n \u003cp\u003e2 (2.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"62.89517470881864%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eMedication taking\u003c/strong\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eNone\u003c/li\u003e\n \u003cli\u003eAnti-dyslipidemia drugs\u003c/li\u003e\n \u003cli\u003eAnti-hypertensive drugs\u003c/li\u003e\n \u003cli\u003eAnti-diabetic drugs\u003c/li\u003e\n \u003cli\u003eLevothyroxine\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eAllopurinol\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.10482529118136%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e40 (55.6)\u003c/p\u003e\n \u003cp\u003e22 (30.6)\u003c/p\u003e\n \u003cp\u003e27 (37.5)\u003c/p\u003e\n \u003cp\u003e13 (18.1)\u003c/p\u003e\n \u003cp\u003e4 (5.6)\u003c/p\u003e\n \u003cp\u003e2 (2.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"62.89517470881864%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eChief complaint\u003c/strong\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eBurning sensation\u003c/li\u003e\n \u003cli\u003eUlceration\u003c/li\u003e\n \u003cli\u003eRoughness\u003c/li\u003e\n \u003cli\u003eNo symptoms\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.10482529118136%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e58 (80.6)\u003c/p\u003e\n \u003cp\u003e47 (65.3)\u003c/p\u003e\n \u003cp\u003e14 (19.4)\u003c/p\u003e\n \u003cp\u003e1 (1.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"62.89517470881864%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eExperienced about OLP treatment\u003c/strong\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eNew patients\u003c/li\u003e\n \u003cli\u003eFollow-up patients\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.10482529118136%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e60 (83.3)\u003c/p\u003e\n \u003cp\u003e12 (16.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"62.89517470881864%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eLocations\u003c/strong\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eLips\u003c/li\u003e\n \u003cli\u003eLabial mucosa\u003c/li\u003e\n \u003cli\u003eBuccal mucosa\u003c/li\u003e\n \u003cli\u003eGingiva\u003c/li\u003e\n \u003cli\u003eTongue\u003c/li\u003e\n \u003cli\u003eFloor of mouth\u003c/li\u003e\n \u003cli\u003ePalate\u0026nbsp;\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.10482529118136%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e12 (16.7)\u003c/p\u003e\n \u003cp\u003e4 (5.6)\u003c/p\u003e\n \u003cp\u003e58 (80.6)\u003c/p\u003e\n \u003cp\u003e55 (76.4)\u003c/p\u003e\n \u003cp\u003e13 (18.1)\u003c/p\u003e\n \u003cp\u003e8 (11.1)\u003c/p\u003e\n \u003cp\u003e5 (6.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"62.89517470881864%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eTopical corticosteroids treated\u003c/strong\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003e0.1% Fluocinolone acetonide in orabase\u003c/li\u003e\n \u003cli\u003e0.05% Clobetasol propionate in orabase\u003c/li\u003e\n \u003cli\u003e0.05% Dexamethasone mouthwash\u003c/li\u003e\n \u003cli\u003e0.1 % Triamcinolone mouthwash\u003c/li\u003e\n \u003cli\u003e0.05% Fluocinolone mouthwash\u003c/li\u003e\n \u003cli\u003e0.1% Fluocinolone solution\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.10482529118136%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e27 (37.5)\u003c/p\u003e\n \u003cp\u003e2 (2.8)\u003c/p\u003e\n \u003cp\u003e23 (31.9)\u003c/p\u003e\n \u003cp\u003e12 (16.6)\u003c/p\u003e\n \u003cp\u003e11 (15.3)\u003c/p\u003e\n \u003cp\u003e1 (1.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eTable 2\u003c/strong\u003e. Comparison of the highest Thongprasom sign score, total Thongprasom sign score, pain score, and total OIDP percentage score outcomes between baseline and 1-month follow-up visit (N = 72).\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" align=\"\" width=\"614\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.8678629690049%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003eIndex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"63.1321370309951%\" colspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003eMean\u0026nbsp;\u0026plusmn;\u0026nbsp;SD (range)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"34.10852713178294%\" valign=\"top\"\u003e\n \u003cp\u003eBaseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"31.782945736434108%\" valign=\"top\"\u003e\n \u003cp\u003eFollow-up\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"34.10852713178294%\" valign=\"top\"\u003e\n \u003cp\u003eDifferences\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.8678629690049%\" valign=\"top\"\u003e\n \u003cp\u003eHighest Thongprasom sign score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e3.9 \u0026plusmn; 2.9\u003c/p\u003e\n \u003cp\u003e(2 - 5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.0652528548124%\" valign=\"top\"\u003e\n \u003cp\u003e2.1 \u0026plusmn; 0.8\u003csup\u003ec\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003e(1 - 4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e1.1 \u0026plusmn; 0.8\u003c/p\u003e\n \u003cp\u003e(-1 - 3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.8678629690049%\" valign=\"top\"\u003e\n \u003cp\u003eTotal Thongprasom sign score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e13.7 \u0026plusmn; 6.8\u003c/p\u003e\n \u003cp\u003e(2 - 30)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.0652528548124%\" valign=\"top\"\u003e\n \u003cp\u003e8.7 \u0026plusmn; 5.2\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003e(0 - 26)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e5.2 \u0026plusmn; 4.1\u003c/p\u003e\n \u003cp\u003e(-1 - 16)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.8678629690049%\" valign=\"top\"\u003e\n \u003cp\u003ePain score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e6.7 \u0026plusmn; 2.6\u003c/p\u003e\n \u003cp\u003e(0 - 10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.0652528548124%\" valign=\"top\"\u003e\n \u003cp\u003e2.9 \u0026plusmn; 2.2\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003e(0 - 10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e3.8 \u0026plusmn; 2.5\u003c/p\u003e\n \u003cp\u003e(0 - 10)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"36.8678629690049%\" valign=\"top\"\u003e\n \u003cp\u003eTotal OIDP percentage score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e19.1 \u0026plusmn; 10.5\u003c/p\u003e\n \u003cp\u003e(1.5 - 48)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.0652528548124%\" valign=\"top\"\u003e\n \u003cp\u003e3.9 \u0026plusmn; 4.8\u003csup\u003ec\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e(0 - 31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e15.2 \u0026plusmn; 8.9\u003c/p\u003e\n \u003cp\u003e(1.5 - 47)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003csup\u003ea\u003c/sup\u003e Subtracted the follow-up data from baseline data and sharing with each n. Negative values represented a worsened effect, whereas positive values represented an improved effect.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003eb\u003c/sup\u003e Statistically significant, compared with baseline, at \u003cem\u003eP\u003c/em\u003e \u0026lt;0.01\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e(paired t-test).\u003c/p\u003e\n\u003cp\u003e\u003csup\u003ec\u003c/sup\u003e Statistically significant, compared with baseline, at \u003cem\u003eP\u003c/em\u003e \u0026lt;0.01\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e(Wilcoxon signed-rank test).\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 3.\u003c/strong\u003e Comparison of each performances\u0026rsquo; outcomes between baseline and 1-month follow-up visit (N = 72).\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"614\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"23.00163132137031%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003ePerformance\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.866231647634583%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eN\u003c/p\u003e\n \u003cp\u003e(%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"63.1321370309951%\" colspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003ePerformance score\u003c/p\u003e\n \u003cp\u003eMean\u0026nbsp;\u0026plusmn;\u0026nbsp;SD (range)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"34.10852713178294%\" valign=\"top\"\u003e\n \u003cp\u003eBaseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"31.782945736434108%\" valign=\"top\"\u003e\n \u003cp\u003eFollow-up\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"34.10852713178294%\" valign=\"top\"\u003e\n \u003cp\u003eDifferences\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"23.00163132137031%\" valign=\"top\"\u003e\n \u003cp\u003eEating\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.866231647634583%\" valign=\"top\"\u003e\n \u003cp\u003e62 (86.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e14.6 \u0026plusmn; 6.1\u003c/p\u003e\n \u003cp\u003e(1 - 25)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.0652528548124%\" valign=\"top\"\u003e\n \u003cp\u003e3.9 \u0026plusmn; 4.3\u003csup\u003ec\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003e(0 - 20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e11.0 \u0026plusmn; 6.3\u003c/p\u003e\n \u003cp\u003e(0 - 20)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"23.00163132137031%\" valign=\"top\"\u003e\n \u003cp\u003eSpeaking\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.866231647634583%\" valign=\"top\"\u003e\n \u003cp\u003e9 (12.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e7.4 \u0026plusmn; 6.9\u003c/p\u003e\n \u003cp\u003e(0 - 20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.0652528548124%\" valign=\"top\"\u003e\n \u003cp\u003e1.3 \u0026plusmn; 2.8\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003e(0 - 8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e6.1 \u0026plusmn; 7.6\u003c/p\u003e\n \u003cp\u003e(-8 - 16)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"23.00163132137031%\" valign=\"top\"\u003e\n \u003cp\u003eCleaning\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.866231647634583%\" valign=\"top\"\u003e\n \u003cp\u003e47 (65.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e12.5 \u0026plusmn; 6.1\u003c/p\u003e\n \u003cp\u003e(1 - 20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.0652528548124%\" valign=\"top\"\u003e\n \u003cp\u003e1.0 \u0026plusmn; 2.6\u003csup\u003ec\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003e(0 - 16)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e11.5 \u0026plusmn; 6.0\u003c/p\u003e\n \u003cp\u003e(1 - 20)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"23.00163132137031%\" valign=\"top\"\u003e\n \u003cp\u003eRelaxing\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.866231647634583%\" valign=\"top\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.0652528548124%\" valign=\"top\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"23.00163132137031%\" valign=\"top\"\u003e\n \u003cp\u003eSmiling\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.866231647634583%\" valign=\"top\"\u003e\n \u003cp\u003e9 (12.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e11.4 \u0026plusmn; 6.4\u003c/p\u003e\n \u003cp\u003e(1 - 20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.0652528548124%\" valign=\"top\"\u003e\n \u003cp\u003e1.9 \u0026plusmn; 2.9\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003e(0 - 9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e9.9 \u0026plusmn; 6.4\u003c/p\u003e\n \u003cp\u003e(1 - 20)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"23.00163132137031%\" valign=\"top\"\u003e\n \u003cp\u003eEmotional stability\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.866231647634583%\" valign=\"top\"\u003e\n \u003cp\u003e68 (94.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e13.6 \u0026plusmn; 7.5\u003c/p\u003e\n \u003cp\u003e(2 - 25)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.0652528548124%\" valign=\"top\"\u003e\n \u003cp\u003e3.3 \u0026plusmn; 4.6\u003csup\u003ec\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003e(0 - 20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e10.1 \u0026plusmn; 7.3\u003c/p\u003e\n \u003cp\u003e(-2 - 25)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"23.00163132137031%\" valign=\"top\"\u003e\n \u003cp\u003eWorking\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.866231647634583%\" valign=\"top\"\u003e\n \u003cp\u003e10 (13.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e5.4 \u0026plusmn; 4.3\u003c/p\u003e\n \u003cp\u003e(2 - 16)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.0652528548124%\" valign=\"top\"\u003e\n \u003cp\u003e1.9 \u0026plusmn; 2.8\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003e(0 - 9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e3.5 \u0026plusmn; 2.4\u003c/p\u003e\n \u003cp\u003e(0 - 8)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"23.00163132137031%\" valign=\"top\"\u003e\n \u003cp\u003eSocial contact\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.866231647634583%\" valign=\"top\"\u003e\n \u003cp\u003e15 (20.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e7.0 \u0026plusmn; 6.2\u003c/p\u003e\n \u003cp\u003e(2 - 25)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.0652528548124%\" valign=\"top\"\u003e\n \u003cp\u003e2.9 \u0026plusmn; 1.7\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003e(0 - 6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.533442088091356%\" valign=\"top\"\u003e\n \u003cp\u003e6.1 \u0026plusmn; 4.8\u003c/p\u003e\n \u003cp\u003e(0 - 25)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003csup\u003ea\u0026nbsp;\u003c/sup\u003eSubtracted the follow-up data from baseline data and sharing with each n.\u0026nbsp;Negative values represented a worsened effect, whereas positive values represented an improved effect.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003eb\u003c/sup\u003e Statistically significant, compared with baseline, at \u003cem\u003eP\u003c/em\u003e \u0026lt;0.05 (Wilcoxon signed-rank test).\u003c/p\u003e\n\u003cp\u003e\u003csup\u003ec\u003c/sup\u003e Statistically significant, compared with baseline, at \u003cem\u003eP\u003c/em\u003e \u0026lt;0.01\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e(Wilcoxon signed-rank test).\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 4\u003c/strong\u003e. Comparison of the differences in clinical and patient-based outcomes between groups of patients who reported up to moderately improved and greatly improved (N = 72).\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"623\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.28846153846154%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eDifferences\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"57.532051282051285%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003eDifferences\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003cp\u003eMean \u0026plusmn; SD (range)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.179487179487179%\" rowspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eP\u003c/em\u003e value\u003csup\u003ec\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"52.646239554317546%\" valign=\"top\"\u003e\n \u003cp\u003eUp to moderately improved\u003csup\u003e\u0026nbsp;b\u003c/sup\u003e (N = 33)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"47.353760445682454%\" valign=\"top\"\u003e\n \u003cp\u003eGreatly improved\u003c/p\u003e\n \u003cp\u003e(N = 39)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.28846153846154%\" valign=\"top\"\u003e\n \u003cp\u003eHighest Thongprasom sign score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.28846153846154%\" valign=\"top\"\u003e\n \u003cp\u003e1.1 \u0026plusmn; 0.6\u003c/p\u003e\n \u003cp\u003e(0 - 3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"27.243589743589745%\" valign=\"top\"\u003e\n \u003cp\u003e1.2 \u0026plusmn; 0.8\u003c/p\u003e\n \u003cp\u003e(0 - 3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.179487179487179%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0.528\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.28846153846154%\" valign=\"top\"\u003e\n \u003cp\u003eTotal Thongprasom sign score\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.28846153846154%\" valign=\"top\"\u003e\n \u003cp\u003e5.3 \u0026plusmn; 3.5\u003c/p\u003e\n \u003cp\u003e(0 - 12)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"27.243589743589745%\" valign=\"top\"\u003e\n \u003cp\u003e5.3 \u0026plusmn; 4.7\u003c/p\u003e\n \u003cp\u003e(-1 - 16)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.179487179487179%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0.820\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.28846153846154%\" valign=\"top\"\u003e\n \u003cp\u003ePain score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.28846153846154%\" valign=\"top\"\u003e\n \u003cp\u003e3.4 \u0026plusmn; 2.6\u003c/p\u003e\n \u003cp\u003e(1 - 10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"27.243589743589745%\" valign=\"top\"\u003e\n \u003cp\u003e4.1 \u0026plusmn; 2.4\u003c/p\u003e\n \u003cp\u003e(1 - 10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.179487179487179%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0.233\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.28846153846154%\" valign=\"top\"\u003e\n \u003cp\u003eTotal OIDP percentage score\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.28846153846154%\" valign=\"top\"\u003e\n \u003cp\u003e12.9 \u0026plusmn; 7.0\u003c/p\u003e\n \u003cp\u003e(1.5 \u0026ndash; 31.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"27.243589743589745%\" valign=\"top\"\u003e\n \u003cp\u003e17.2 \u0026plusmn; 10.0\u003c/p\u003e\n \u003cp\u003e(4.5 - 47)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.179487179487179%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0.079\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003csup\u003ea\u003c/sup\u003e Subtracted the follow-up data from baseline data and sharing with each n. Negative values represented a worsened effect, whereas positive values represented an improved effect.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003eb\u003c/sup\u003e Including 1 no changes, 4 minimally improved and 28 moderately improved patients.\u003c/p\u003e\n\u003cp\u003e\u003csup\u003ec\u003c/sup\u003e Statistically analyzed with Mann-Whitney U test.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 5.\u0026nbsp;\u003c/strong\u003eRelationships of the differences among the total OIDP percentage score, highest Thongprasom sign score, total Thongprasom sign score and pain score.\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"680\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" rowspan=\"3\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eDifferences\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"66.66666666666667%\" colspan=\"6\" valign=\"top\"\u003e\n \u003cp\u003eDifferences\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"39.647577092511014%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003eTotal Thongprasom score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"31.277533039647576%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003ePain score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"29.07488986784141%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003eOIDP\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"18.763796909492275%\" valign=\"top\"\u003e\n \u003cp\u003er\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.750551876379692%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eP\u003c/em\u003e value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.777041942604857%\" valign=\"top\"\u003e\n \u003cp\u003er\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.56953642384106%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eP\u003c/em\u003e value\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.56953642384106%\" valign=\"top\"\u003e\n \u003cp\u003er\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.56953642384106%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eP\u003c/em\u003e value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.38235294117647%\" valign=\"top\"\u003e\n \u003cp\u003eHighest Thongprasom sign score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.5%\" valign=\"top\"\u003e\n \u003cp\u003e0.293\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.823529411764707%\" valign=\"top\"\u003e\n \u003cp\u003e0.012\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.176470588235293%\" valign=\"top\"\u003e\n \u003cp\u003e0.109\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.705882352941176%\" valign=\"top\"\u003e\n \u003cp\u003e0.362\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.705882352941176%\" valign=\"top\"\u003e\n \u003cp\u003e0.198\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.705882352941176%\" valign=\"top\"\u003e\n \u003cp\u003e0.096\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003eTotal Thongprasom sign score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.431718061674008%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.160058737151248%\" valign=\"top\"\u003e\n \u003cp\u003e0.118\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.691629955947137%\" valign=\"top\"\u003e\n \u003cp\u003e0.324\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.691629955947137%\" valign=\"top\"\u003e\n \u003cp\u003e0.335\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.691629955947137%\" valign=\"top\"\u003e\n \u003cp\u003e0.004\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"33.333333333333336%\" valign=\"top\"\u003e\n \u003cp\u003ePain score\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.431718061674008%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"20.851688693098385%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.691629955947137%\" valign=\"top\"\u003e\n \u003cp\u003e0.427\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.691629955947137%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003csup\u003ec\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003csup\u003ea\u003c/sup\u003e Statistically significant at \u003cem\u003eP\u003c/em\u003e \u0026lt;0.05 (Pearson\u0026rsquo;s correlation).\u003c/p\u003e\n\u003cp\u003e\u003csup\u003eb\u003c/sup\u003e Statistically significant at \u003cem\u003eP\u003c/em\u003e \u0026lt;0.01 (Pearson\u0026rsquo;s correlation).\u003c/p\u003e\n\u003cp\u003e\u003csup\u003ec\u003c/sup\u003e Statistically significant at \u003cem\u003eP\u003c/em\u003e \u0026lt;0.001 (Pearson\u0026rsquo;s correlation).\u0026nbsp;\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"bmc-oral-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ohea","sideBox":"Learn more about [BMC Oral Health](http://bmcoralhealth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ohea/default.aspx","title":"BMC Oral Health","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Oral lichen planus, Quality of life, Oral health related quality of life, Oral impact on daily performances index, OIDP, Topical corticosteroid treatment","lastPublishedDoi":"10.21203/rs.3.rs-3153939/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3153939/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eOral lichen planus (OLP) is a common chronic inflammatory disease of the oral cavity that affects many patients\u0026rsquo; daily living activities. The goal of treating OLP is to relieve symptomatic pain, and reduce inflammation. Topical corticosteroids are the first-line drug for treating OLP. OLP clinical trials should use a tripartite approach comprising clinical signs, symptoms, and quality of life. The Oral Impact on Daily Performances index (OIDP) is an Oral-Health-Related Quality of Life (OHRQoL) measure developed to assess the ultimate impacts. The aims of this study were to evaluate the clinical, pain and OHRQoL responses after treating OLP patients with topical corticosteroids for 1 month, and secondly to assess the relationships of changes in the clinical sign score, pain score, and OHRQoL.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eSeventy-two OLP patients were recruited to assess their clinical outcomes and patient-based outcomes after treating them with topical corticosteroids for 1 month. The clinical outcomes were evaluated by the highest and total Thongprasom sign score. The patient-based outcomes were evaluated by a pain rating scale using a numeric rating scale (NRS), and OIDP. The self-rated overall changes in quality of life during the 1-month treatment period using the Patient Global Impression of Change (PGIC) were also recorded at the follow-up visit.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThis study comprised 59 women (81.9%) and 13 men (18.1%). The total OIDP percentage score was 19.1\u0026thinsp;\u0026plusmn;\u0026thinsp;10.5 at baseline. The most commonly affected activities were Emotional stability (94.4%), followed by Eating (86.1%) and Cleaning the oral cavity (65.3%). At the 1-month follow-up visit, the highest Thongprasom sign score, total Thongprasom sign score, pain score and total OIDP percentage score were significantly reduced after treatment with topical corticosteroids (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.01). None of the patients reported a lower quality of life. Forty-six percent reported the same or up to moderately improved, while 54% had a greatly improved quality of life as assessed by PGIC. There were no significant differences in the improvement of clinical and patient-based outcomes between these outcome groups. There were significant relationships between the difference in the highest Thongprasom sign score and the difference in total Thongprasom sign score (r\u0026thinsp;=\u0026thinsp;0.293; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05), and the differences in total OIDP percentage score and the difference in pain score (r\u0026thinsp;=\u0026thinsp;0.427; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001). The differences in the total Thongprasom sign score also significantly related to the difference in the total OIDP percentage score (r\u0026thinsp;=\u0026thinsp;0.335; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.01). However, no significant relationship was found between the difference in the highest Thongprasom sign score and the difference in patient-based outcomes.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eTopical corticosteroids were significantly effective after 1-month treatment of OLP based on the clinical and patient-based outcomes. The OHRQoL improvement was significantly related to the reductions in pain and clinical severity.\u003c/p\u003e\u003ch2\u003eTrial registration\u003c/h2\u003e \u003cp\u003eThe trial was registered at the Thai Clinical Trials Registry (TCTR identifier: TCTR 20221110001).\u003c/p\u003e","manuscriptTitle":"Changes in the Oral-Health-Related Quality of Life of Thai patients with oral lichen planus after topical corticosteroid treatment: a 1-month longitudinal study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2023-08-07 05:48:24","doi":"10.21203/rs.3.rs-3153939/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2023-09-11T16:27:03+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2023-08-28T15:25:00+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2023-08-14T10:29:15+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"d9022e0d-43dd-4b42-8811-abee2b82494c","date":"2023-08-10T15:40:06+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"126d31d8-64c6-490b-b56b-8cbd21d93f0c","date":"2023-08-10T00:34:11+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2023-08-09T12:17:23+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2023-08-09T12:02:40+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2023-08-01T17:35:28+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2023-08-01T17:29:05+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Oral Health","date":"2023-07-09T13:53:16+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"
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