Ceramic Soft Tissue Trimming Bur Gingival Depigmentation: Clinical Performance and Patient Experience. “A Split Mouth Randomized Controlled Trial”

Ceramic Soft Tissue Trimming Bur Gingival Depigmentation: Clinical Performance and Patient Experience. “A Split Mouth Randomized Controlled Trial” | 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 Ceramic Soft Tissue Trimming Bur Gingival Depigmentation: Clinical Performance and Patient Experience. “A Split Mouth Randomized Controlled Trial” Sally Khaled Nassar, Hala Ahmed Abu El-Ela, Yasmine Ahmed Fouad This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3943266/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 9 You are reading this latest preprint version Abstract Background Ceramic soft tissue trimming bur (Cerabur) was primarily launched to be used in gingivoplasty but has been used recently in gingival depigmentation. This study aimed to compare the efficacy of depigmentation using the novel cerabur versus the gold-standard surgical scalpel technique. Methods Eight healthy, non-smokers with moderate to severe gingival hyperpigmentation in both arches were randomly assigned for cerabur depigmentation in one arch as a test group (TG) and scalpel depigmentation in the opposite arch as a control group (CG). Pigmentation indices were used to assess the clinical outcome. Treatment time, pain levels, and esthetic satisfaction were the parameters of patient experience. The assessment was done at baseline, 1 week, 1 month, and 3 months. Results At all the assessment visits, the pigmentation intensity represented by Dummet oral pigmentation index (DOPI), and distribution represented by Hedin melanin index (MI) were significantly less than baseline ( p < 0.001) in both groups. When comparing both groups, Scalpel depigmentation had better initial clinical outcomes, while Cerabur had less visible re-pigmentation, pain Scores, and treatment time, along with more esthetic satisfaction. However, all these differences were not statistically significant. Conclusion Both techniques successfully removed the gingival hyperpigmentation with comparable clinical outcomes. Cerabur depigmentation was favored by the patients. Trial registration: The study protocol was registered on 11/09/2023 on the www.clinicaltrials.gov database (NCT06031116) after the approval of the Ethics Committee, Faculty of Dentistry, Ain Shams University (FDASU-Rec012124). Ceramic bur Ceramic soft tissue trimmer Scalpel Melanin Hyperpigmentation Gingival Depigmentation periodontal surgery Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 1. Background Dark gums or gingival hyperpigmentation compromises the harmony of the smile and the overall facial esthetics. Many individuals seek treatment for hyperpigmentation especially those with a high smile line ( 1 ). Gingival hyperpigmentation is caused by highly active melanocytes resulting in excessive deposition of melanin pigments in the basal and supra basal layers of the epithelium. This increased activity of melanocytes can be physiological, pathological, drug-induced, or caused by smoking. Accordingly, a meticulous medical and personal history should be obtained to detect the etiology of melanin hyperpigmentation( 2 ). A plethora of techniques have been utilized to remove melanocytic pigmentation, both surgical and non-surgical. The surgical techniques include surgical stripping, bur abrasion, cryosurgery, electrosurgery, lasers, or masking the pigmented gingiva using free gingival autografts and acellular dermal matrix allografts. The non-surgical techniques include ascorbic acid (Vitamin C), salicylic acid, glycolic acid, trichloroacetic acid, and phenols. Many studies have reviewed the gingival depigmentation techniques. However, there is no consensus on which technique is the most effective, pleasant, or reliable ( 3 , 4 ). The available treatment modalities either involve a bloody surgical field, require sophisticated equipment, or demand multiple applications to achieve the desired outcome ( 3 , 5 ). However, there is no consensus on which technique is better regarding clinical outcomes, stability of results, or patient satisfaction. Cerabur is a flame-shaped cylinder made of ceramic oxide. These trimmers are inserted in a high-speed handpiece and used without water coolant. The heat generated from friction ablates the tissues and simultaneously coagulates the blood vessel ends resulting in minimal bleeding ( 6 ). Gingival depigmentation by cerabur has been reported in a case study ( 7 ), and a case series ( 8 )and achieved comparable results with laser in a randomized clinical trial( 6 ). Cerabur depigmentation is a simple, effective, and minimally invasive clinical procedure( 7 ). This study aimed to compare gingival depigmentation using ceramic soft tissue trimming bur versus the conventional surgical scalpel technique as both are simple, cost-effective methods for depigmentation. 2. Participants and Methods 2.1 Study design, patient grouping, and randomization This study is a prospective split-mouth randomized clinical trial (RCT). The dental arches of each patient were randomly allocated to the two groups with a ratio of 1:1 according to the predetermined computer-generated randomization. The allocation was concealed by (YA) in sequentially numbered envelopes until the intervention. The participants were randomly assigned for cerabur depigmentation in one arch (TG) and scalpel depigmentation in the opposite arch (CG) . 2.1.1 Study sample, sample calculation and power analysis This study was conducted on sixteen dental arches of eight patients seeking treatment for gingival hyperpigmentation for esthetic purposes. The patients were recruited from the outpatient clinic of the Department of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Ain Shams University. A power analysis was designed to have adequate power to apply a two-sided statistical test of the null hypothesis that there is no difference would be found between different tested groups. By adopting an alpha (α) level of 0.05 (5%), a beta (β) level of 0.2 (i.e., power = 80%), and an effect size (d) of (1.931) calculated based on the results of a previous study with the same primary outcome ( 9 ); the predicted sample size (n) was a total of ( 6 ) cases. The sample size was increased by (25%) to compensate for possible drop-out during different follow-up intervals to be a total of ( 8 ) cases. Sample size calculation was performed using G*Power version 3.1.9.7 1 . 2.1.2 Ethics approval: This study was conducted after approval was granted by the Research Ethical Committee at the Faculty of Dentistry- Ain Shams University, (FDASU-Rec012124) and was registered on 11/09/2023 at https://clinicaltrials.gov/ under the number (NCT06031116). 2.1.3 Inclusion and Exclusion Criteria: Fifteen subjects were assessed to find the eight subjects who met the inclusion criteria: Gingival pigmentation score ≥ 3 on Hedin melanin index in both arches, good oral hygiene, thick gingival phenotype, and ASA (American Academy of Anesthesiologists) class I individuals. Smokers, periodontally compromised, pregnant and lactating females, patients with mental or physical disabilities, and patients who suffer from pathologies or take medications that cause gingival pigmentation were excluded from the study. 2.2 Treatment Protocol 2.2.1 Preoperative preparations and instructions: All Patients received non-surgical periodontal debridement two weeks before the depigmentation session and they were instructed to perform proper oral hygiene measures. 2.2.2. TG: Ceramic soft tissue trimming bur (Cerabur) depigmentation: Local anesthesia (Articaine with epinephrine 1:100:000, Laboratories Inibsa, Spain) was achieved by infiltration technique on the buccal aspect. Cerabur (Ceratip, Komet, USA.) was used in a high-speed handpiece without water coolant to remove the epithelial layer, excise and contour the gingival soft tissues. During the procedure, the gingiva as well as the Ceramic bur were cleaned from gingival debris with sterile gauze soaked with saline. Figure 1 . 2.2.3 CG: Conventional scalpel surgical scraping technique: Local anesthesia was achieved in the same manner as TG. Followed by scraping of the pigmented gingival epithelium using no. 15 bard Parker blade. Care was taken to include the pigmented epithelium at the tip of the interdental papilla and at the muco-gingival junction on the other end. Hemostasis was obtained with sterile gauze and direct pressure. Figure 2 and Fig. 3. 2.2.4 Postoperatively: After completing both procedures, the exposed surface was irrigated with saline and the surgical area was covered with a periodontal pack (COE-PAK, GC America) for 1 week for both groups. The patients were instructed to avoid hot and spicy food for 24 hours after surgery and to continue mechanical oral hygiene while avoiding the operated area. Ibuprofen 200 mg was prescribed immediately after surgery and the patients were advised to continue with the medication for 3 days after surgery if pain was experienced. 2.3 Assessment Clinical assessment was done at baseline and after 1 week, 1 month, and 3 months. The assessed parameters included: Pigmentation indices : Dummet oral pigmentation index (DOPI): (Primary outcome) the degree of gingival pigmentation was scored as 0 : pink tissue; 1 : mild light brown tissue; 2 : medium brown or mixed brown and pink tissue; 3 : deep brown/ blue–black tissue. Hedin melanin index (MI) : the extent of gingival pigmentation was scored as 0 : no pigmentation; 1 : one or two solitary units of pigmentation in the papillary gingiva; 2 : >3 units of pigmentation in the papillary gingiva without formation of a continuous ribbon; 3 : >1 short continuous ribbons of pigmentation; 4 : one continuous ribbon including the entire area between canines. Parameters of patient experience: (Secondary outcomes) Operating time : The time needed to complete each procedure was calculated in minutes by using a stopwatch from the time of the application of local anesthetic till the placement of the periodontal pack. Patient’s esthetic satisfaction : was reported using the Global Aesthetic Improvement Scale (GAIS) where: 1 : Excellent improvement; 2 : Very improved; 3 : Improved; 4 : unaltered; 5 : worsened. The patients reported their degree of satisfaction with the aesthetic outcome of the procedure 1 month postoperatively. Pain perception was reported using Visual Analogue Scale (VAS) at 24 hours, 2 days, 3–5 days, and 7 days post-operatively. (Zero is for minimum pain and ten is for maximum pain). The patients were asked to keep a diary of the perceived pain levels as well as their analgesic consumption if any. 2.4 Data management and Statistical analysis : Numerical data were presented as mean and standard deviation values. They were analyzed for normality using Shapiro-Wilk’s test. Data were non-parametric and were analyzed using Friedman’s test followed by Nemenyi post hoc test. The significance level was set at P < 0.05 within all tests. Statistical analysis was performed with R statistical analysis software version 4.3.0 for Windows 2 . 3. Results The study was conducted on 8 patients 2 (25%) males and 6 (75%) females with a mean age of (23.88 ± 2.85) years. All the included participants have met the eligibility criteria and received both treatment and control interventions on either arch depending on the randomization. Figure 4 3.1 Clinical outcomes: Dummet oral pigmentation index (DOPI) : for both groups TG & CG there was a significant difference between values measured at different intervals (p < 0.001). The highest value was found at baseline (2.25 ± 0.71), followed by 3 months (0.12 ± 0.35), while the lowest value was found at 1 month (0.00 ± 0.00). Post hoc pairwise comparisons showed the baseline to have a significantly higher value than values measured at other intervals ( P < 0.001). Table (1). Table (1) Inter and intragroup comparisons, mean and standard deviation (SD) values for VAS for both groups (Values with different superscript letters within the same vertical column are significantly different *; significant (p ≤ 0.05) ns; non-significant (p>0.05)) Time DOPI (Mean ± SD) P -value Test Control Baseline 2.25 ± 0.71 a 2.25 ± 0.71 a 1ns 1 month 0.00 ± 0.00 b 0.00 ± 0.00 b 1ns 3 months 0.12 ± 0.35 b 0.12 ± 0.35 b 1ns p-value < 0.001* < 0.001* Hedin melanin index (MI) The percentage change in MI at different intervals was CG (93.75 ± 17.68) had a higher value than TG (89.58 ± 14.60), when comparing baseline to 1 month and TG (80.21 ± 22.69) had a higher value than CG (77.08 ± 28.43) when comparing baseline to 3 months. Both differences were statistically insignificant ( P = 0.854) for baseline to 1 month and ( P = 0.812) for baseline to 3 months. Inter and intra group comparisons of MI scores are shown in table (2) Table 2 Inter and intragroup comparisons, mean and standard deviation (SD) values for MI for both groups at different time intervals (Values with different superscript letters within the same vertical column are significantly different *; significant (p ≤ 0.05) ns; non-significant (p>0.05) Time HEDIN Melanin index (Mean ± SD) p-value Test Control Baseline 3.75 ± 0.46 a 3.75 ± 0.46 a 1ns 1 month 0.38 ± 0.52 b 0.25 ± 0.71 b 0.850ns 3 months 0.75 ± 0.89 b 0.88 ± 1.13 b 1ns p-value < 0.001* < 0.001* 3.2 Patient experience: Operating time: CG (13.88 ± 3.56) had a higher value than TG (13.75 ± 2.12), yet the difference was not statistically significant ( P = 0.925). Figure 5 . Patients’ esthetic satisfaction (GAIS) CG (2.00 ± 0.76) had a higher value than TG (1.88 ± 0.64), yet the difference was not statistically significant ( P = 0.766). Figure 6 . Pain perception (VAS): CG had higher pain values than TG on day 1, day 2 and day 3–5 yet the difference was not statistically significant (p = 0.169), (p = 0.752), (p = 0.571) respectively. 1 week post operatively only one patient in the TG reported residual pain, while no one reported pain in the CG . The difference was not statistically significant ( P = 1). Table 3 . Table 3 Inter and intragroup comparisons, mean and standard deviation (SD) values for VAS for both groups (Values with different superscript letters within the same vertical column are significantly different *; significant (P ≤ 0.05) ns; non-significant (P>0.05)) Time VAS (Mean ± SD) p-value Test Control day 1 1.88 ± 2.42 a 3.38 ± 2.00 a 0.169ns day 2 2.50 ± 2.56 a 3.12 ± 1.81 a 0.752ns day 3–5 1.25 ± 1.58 a 1.62 ± 1.19 ab 0.571ns 1 week 0.12 ± 0.35 a 0.00 ± 0.00 b 1ns p-value 0.062ns < 0.001* 4. Discussion This RCT aimed to compare both techniques regarding clinical outcomes, pain perception, patient satisfaction, and stability of the results. To the best of our knowledge, there are no published clinical trials to compare the outcomes of gingival depigmentation by ceramic soft tissue trimming bur with the surgical stripping technique. The scalpel technique is still a gold standard in gingival depigmentation. The popularity of the scalpel technique is owed to its efficiency, affordability, and simplicity. However, this technique has the drawbacks of a bloody field of surgery, probable infections, and a high rate of recurrence( 10 – 12 ). Cerabur was selected in this study as a novel and promising technique for gingival depigmentation that shares the affordability and ease of use of the surgical stripping technique with the additional benefit of good hemostasis and cleanliness of the operating field ( 7 ). The study was conducted in a split-mouth fashion ( 13 , 14 ). This design was selected to evade the inter-subject variables such as age, facial complexion, genetics, and environmental risk factors. The inter-subject variables could induce bias in the estimated treatment effect and the pain perception of the individual ( 15 ). The decision to employ the arches design over the quadrant design was to avoid color disparity in the same arch which might be dissatisfactory to the patient. Carry-over effects may induce bias in split-mouth RCTs( 16 ). Consequently, in this study one dental arch of each patient was treated according to the assigned randomization and the opposing arch was not treated until the patient reported no pain (0 on VAS). Periodontal pack placement is not mandatory. However, there are multiple benefits to applying a periodontal pack post-surgically including less post-operative pain score reported by the patients and slightly better healing ( 17 , 18 ). Application of a periodontal pack after both procedures in accordance with previous studies ( 6 , 7 , 12 , 19 ). DOPI, as well as MI pigmentation indices, were both used to attain more accurate results as DOPI is based on the color intensity of the gingival pigmentation whereas MI is based on the extent and the distribution of the pigments. Previous studies have used two pigmentation indices for the same reason.( 6 , 20 ) The results of the present study showed a statistically significant reduction in DOPI values in both groups from baseline. Gholami et al., 2018 compared surgical stripping and ErCr: YSGG (Erbium, chromium-doped yttrium, scandium, gallium, and garnet) Laser depigmentation and Negi et al., 2019 compared cerabur and diode laser depigmentation. They both reported a significant decrease in pigmentation indices from baseline ( 6 , 21 ). The percentage change in MI was different for both groups with the cerabur having lower value when comparing baseline to 1 month and higher values when comparing baseline to 3 months. This shows better initial clinical outcomes of the surgical stripping technique and superior stability of the cerabur results. However, the difference was not statistically significant. These findings were analogous to the findings of Gholami et al., 2018 who found no difference between the recurrence rates of scalpel and ErCr: YSGG laser( 21 ). However, they are in contrast with Penmetsa et al., 2019 who found significantly higher recurrence rates with scalpel depigmentation when compared to cryosurgery( 22 ). Gingival re-pigmentation after depigmentation is one of the drawbacks of the procedure. It is hypothesized that gingival re-pigmentation occurs due to the migration of neighboring melanocytes. The re-pigmentation rate of the two techniques was measured at the end of the follow-up period, 3 months post-operative, to compare the stability of the results( 12 , 23 ). DOPI and MI baseline values were the highest followed by 3 months, then 1 month. This is due to the re-appearance of some pigments in the form of spots, dots, or stria in some of the subjects at the 3 months assessment visit ( 24 ). VAS was employed to evaluate the patients’ perception of pain in each arch due to its simplicity and reliability( 25 ). There was no statistically significant difference between patient-reported VAS scores. These results were in contrast with Negi et al., 2019 who found significantly more pain in sites treated with cerabur compared to diode laser( 6 ). The pain levels in this study were comparable to previous studies( 23 , 26 ) that reported more pain in sites treated with scalpel compared to laser and aligned with studies( 12 , 21 ) that didn’t find any significant difference in pain levels when comparing lasers with surgical scalpel. The frictional heat of the cerabur caused tissue coagulation and minimal bleeding. The localized heat causes coagulation, protein denaturation, drying, vaporization, and carbonization. As a result, blood vessels and sensory nerve endings are sealed. This may explain the faintly lower pain levels in the cerabur sites compared with the scalpel sites( 6 , 27 ). GAIS was adopted from plastic surgery and cosmetic literature( 28 , 29 ) to measure the patient’s level of satisfaction with the aesthetic outcome. Cerabur had better patient satisfaction scores. More patients appreciated the less invasive and less bloody nature of the cerabur procedure over the scalpel surgery. 5. Conclusion Clinical performance of cerabur and scalpel was similar while the overall patient experience (Pain, Esthetic satisfaction, and treatment time) was in favor of the cerabur. Cerabur depigmentation is an effective, bloodless, easy-to-perform technique that does not require sophisticated armamentarium. Cerabur depigmentation is a practical substitute for the standard scalpel stripping technique. 6. Recommendations More clinical trials of bigger sample size and longer follow up periods are needed to further evaluate the efficacy and stability of results of the ceramic soft tissue trimmer in depigmentation of the gingiva. Further research comparing the ceramic soft tissue trimmer with other depigmentation techniques. Histological studies should be done to further understand the mechanism of re-pigmentation. 7. List of abbreviations Cerabur: Ceramic soft tissue trimming bur. TG: Test group CG: Control group DOPI: Dummet oral pigmentation index MI: Melanin Index RCT: Randomized controlled trial. ASA: American Academy of Anesthesiologists GAIS: Global Aesthetic improvement scale VAS: Visual analogue scale ErCr: YSGG: Erbium, chromium-doped yttrium, scandium, gallium, and garnet 8. Declarations Ethics approval and consent to participate: This study was approved by the Ethics Committee, Faculty of Dentistry, Ain Shams University (FDASU-Rec012124) and performed in accordance with the Declaration of Helsinki. Informed consent was obtained from all subjects and/or their legal guardian(s). Consent for publication: not applicable Availability of data and materials: The data supporting the findings of this study are available upon request from the corresponding author. Competing interests: The authors declare no competing interests. Funding: There was no funding provided to the authors by any organization Authors contributions: SN: Conceptualization, Methodology, Investigation, Resources, Data Curation, Writing- Original draft preparation. HA: Conceptualization, Methodology, Writing- Review & Editing, Supervision. YA: Methodology, Data curation, Writing- Review & Editing. 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Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 22 Mar, 2024 Reviews received at journal 14 Mar, 2024 Reviewers agreed at journal 14 Mar, 2024 Reviewers agreed at journal 03 Mar, 2024 Reviewers invited by journal 03 Mar, 2024 Editor assigned by journal 03 Mar, 2024 Editor invited by journal 01 Mar, 2024 Submission checks completed at journal 01 Mar, 2024 First submitted to journal 09 Feb, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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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-3943266","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":276334435,"identity":"378fc6f7-f339-4b89-b950-ca5f2bef93ea","order_by":0,"name":"Sally Khaled Nassar","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA7UlEQVRIiWNgGAWjYBAC+QbmxgOMbWA24wMgwcNHSIvBAcaGA4zHwGxmA5AWNoJaGEBanoHZbBJgkqAW9saGw7zP7Ozl288+q/yaYyfDxsD88NENPFrkew4CtWxLTtxwJt3stuy2ZKDD2IyNc/BZcyMRpIU5wYAhje225DZmoBYeNmnCWubV28v3P2MrltxWT6yWvsOMDTfS2Bg/bjtMWIvBmYMNB+f2HU/ccOMZszTjtuM8bMwE/CLf3nzwwdu2aqDD0hg//txWbc/P3vzwMV6HAQETD5TBDGYwE1AOAow/0BmjYBSMglEwCpABADqoTMSj+1PBAAAAAElFTkSuQmCC","orcid":"","institution":"Ain Shams University","correspondingAuthor":true,"prefix":"","firstName":"Sally","middleName":"Khaled","lastName":"Nassar","suffix":""},{"id":276334436,"identity":"b785a91b-eeaa-45ba-8bad-4b7cd96be5a3","order_by":1,"name":"Hala Ahmed Abu El-Ela","email":"","orcid":"","institution":"Ain Shams University","correspondingAuthor":false,"prefix":"","firstName":"Hala","middleName":"Ahmed Abu","lastName":"El-Ela","suffix":""},{"id":276334437,"identity":"460b8db3-8fa2-47ac-ad36-c4e74b464f7f","order_by":2,"name":"Yasmine Ahmed Fouad","email":"","orcid":"","institution":"Ain Shams University","correspondingAuthor":false,"prefix":"","firstName":"Yasmine","middleName":"Ahmed","lastName":"Fouad","suffix":""}],"badges":[],"createdAt":"2024-02-09 14:33:40","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3943266/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3943266/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":52031708,"identity":"e40143c9-5683-470d-bb77-c98e7535851e","added_by":"auto","created_at":"2024-03-05 16:31:48","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":96278,"visible":true,"origin":"","legend":"\u003cp\u003eDepigmentation using ceramic bur.\u003c/p\u003e","description":"","filename":"image1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3943266/v1/8322784d6d341b8796374369.jpg"},{"id":52031706,"identity":"de367c12-670b-4656-a2a5-cfae2dd032ed","added_by":"auto","created_at":"2024-03-05 16:31:48","extension":"jpeg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":71997,"visible":true,"origin":"","legend":"\u003cp\u003epreoperative picture of patient with melanin hyperpigmentation in both arches.\u003c/p\u003e","description":"","filename":"image2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-3943266/v1/7e75d7ccaf62832feed21423.jpeg"},{"id":52031069,"identity":"b12b9176-aa83-4a60-8217-18844f4bfecb","added_by":"auto","created_at":"2024-03-05 16:23:48","extension":"jpeg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":53602,"visible":true,"origin":"","legend":"\u003cp\u003eSame patient from Fig.2 3 months post-operative. Upper arch cerabur depigmentation, lower arch scalpel depigmentation\u003c/p\u003e","description":"","filename":"image3.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-3943266/v1/c97868a53cb9766ef12b5adb.jpeg"},{"id":52031066,"identity":"cb0b636e-09c7-4ef7-987b-08ff6cbc6aa3","added_by":"auto","created_at":"2024-03-05 16:23:48","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":206940,"visible":true,"origin":"","legend":"\u003cp\u003eFlowchart of the study illustrating patient recruitments, appointments, and procedures.\u003c/p\u003e","description":"","filename":"image4.png","url":"https://assets-eu.researchsquare.com/files/rs-3943266/v1/20afafea574ea1e198149ef5.png"},{"id":52033084,"identity":"d4e52f2e-800d-4fd6-8859-1ef74ce865c2","added_by":"auto","created_at":"2024-03-05 16:39:48","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":16808,"visible":true,"origin":"","legend":"\u003cp\u003eBar chart showing mean and standard deviation values (error bars) for operating time (min) for both groups.\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-3943266/v1/edbce0b7e6e7328e6ef1a175.png"},{"id":52031071,"identity":"e55f3375-af86-42dc-a1fd-ad9ec5514923","added_by":"auto","created_at":"2024-03-05 16:23:49","extension":"png","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":15334,"visible":true,"origin":"","legend":"\u003cp\u003eBar chart showing mean and standard deviation values (error bars) for GAIS for both groups.\u003c/p\u003e","description":"","filename":"6.png","url":"https://assets-eu.researchsquare.com/files/rs-3943266/v1/5e78adf642b1f8525532f3ce.png"},{"id":52034265,"identity":"bf78ba53-4c6e-4c86-9d0a-607402233f4b","added_by":"auto","created_at":"2024-03-05 16:47:49","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":878605,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3943266/v1/36ecfa93-2a12-43a8-9886-cdd5edaf3645.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Ceramic Soft Tissue Trimming Bur Gingival Depigmentation: Clinical Performance and Patient Experience. “A Split Mouth Randomized Controlled Trial”","fulltext":[{"header":"1. Background","content":"\u003cp\u003eDark gums or gingival hyperpigmentation compromises the harmony of the smile and the overall facial esthetics. Many individuals seek treatment for hyperpigmentation especially those with a high smile line (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eGingival hyperpigmentation is caused by highly active melanocytes resulting in excessive deposition of melanin pigments in the basal and supra basal layers of the epithelium. This increased activity of melanocytes can be physiological, pathological, drug-induced, or caused by smoking. Accordingly, a meticulous medical and personal history should be obtained to detect the etiology of melanin hyperpigmentation(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eA plethora of techniques have been utilized to remove melanocytic pigmentation, both surgical and non-surgical. The surgical techniques include surgical stripping, bur abrasion, cryosurgery, electrosurgery, lasers, or masking the pigmented gingiva using free gingival autografts and acellular dermal matrix allografts. The non-surgical techniques include ascorbic acid (Vitamin C), salicylic acid, glycolic acid, trichloroacetic acid, and phenols. Many studies have reviewed the gingival depigmentation techniques. However, there is no consensus on which technique is the most effective, pleasant, or reliable (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe available treatment modalities either involve a bloody surgical field, require sophisticated equipment, or demand multiple applications to achieve the desired outcome (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). However, there is no consensus on which technique is better regarding clinical outcomes, stability of results, or patient satisfaction.\u003c/p\u003e \u003cp\u003eCerabur is a flame-shaped cylinder made of ceramic oxide. These trimmers are inserted in a high-speed handpiece and used without water coolant. The heat generated from friction ablates the tissues and simultaneously coagulates the blood vessel ends resulting in minimal bleeding (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Gingival depigmentation by cerabur has been reported in a case study (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e), and a case series (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e)and achieved comparable results with laser in a randomized clinical trial(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Cerabur depigmentation is a simple, effective, and minimally invasive clinical procedure(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThis study aimed to compare gingival depigmentation using ceramic soft tissue trimming bur versus the conventional surgical scalpel technique as both are simple, cost-effective methods for depigmentation.\u003c/p\u003e"},{"header":"2. Participants and Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n \u003ch2\u003e2.1 Study design, patient grouping, and randomization\u003c/h2\u003e\n \u003cp\u003eThis study is a prospective split-mouth randomized clinical trial (RCT). The dental arches of each patient were randomly allocated to the two groups with a ratio of 1:1 according to the predetermined computer-generated randomization. The allocation was concealed by (YA) in sequentially numbered envelopes until the intervention. The participants were randomly assigned for cerabur depigmentation in one arch \u003cstrong\u003e(TG)\u003c/strong\u003e and scalpel depigmentation in the opposite arch \u003cstrong\u003e(CG)\u003c/strong\u003e.\u003c/p\u003e\n \u003cdiv id=\"Sec4\" class=\"Section3\"\u003e\n \u003ch2\u003e2.1.1 Study sample, sample calculation and power analysis\u003c/h2\u003e\n \u003cp\u003eThis study was conducted on sixteen dental arches of eight patients seeking treatment for gingival hyperpigmentation for esthetic purposes. The patients were recruited from the outpatient clinic of the Department of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Ain Shams University.\u003c/p\u003e\n \u003cp\u003eA power analysis was designed to have adequate power to apply a two-sided statistical test of the null hypothesis that there is no difference would be found between different tested groups. By adopting an alpha (\u0026alpha;) level of 0.05 (5%), a beta (\u0026beta;) level of 0.2 (i.e., power\u0026thinsp;=\u0026thinsp;80%), and an effect size (d) of (1.931) calculated based on the results of a previous study with the same primary outcome (\u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e); the predicted sample size (n) was a total of (\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e) cases. The sample size was increased by (25%) to compensate for possible drop-out during different follow-up intervals to be a total of (\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e) cases. Sample size calculation was performed using G*Power version 3.1.9.7\u003csup\u003e1\u003c/sup\u003e.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec5\" class=\"Section3\"\u003e\n \u003ch2\u003e2.1.2 Ethics approval:\u003c/h2\u003e\n \u003cp\u003eThis study was conducted after approval was granted by the Research Ethical Committee at the Faculty of Dentistry- Ain Shams University, (FDASU-Rec012124) and was registered on 11/09/2023 at \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://clinicaltrials.gov/\u003c/span\u003e\u003c/span\u003e under the number (NCT06031116).\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec6\" class=\"Section3\"\u003e\n \u003ch2\u003e2.1.3 Inclusion and Exclusion Criteria:\u003c/h2\u003e\n \u003cp\u003eFifteen subjects were assessed to find the eight subjects who met the inclusion criteria: Gingival pigmentation score\u0026thinsp;\u0026ge;\u0026thinsp;3 on Hedin melanin index in both arches, good oral hygiene, thick gingival phenotype, and ASA (American Academy of Anesthesiologists) class I individuals. Smokers, periodontally compromised, pregnant and lactating females, patients with mental or physical disabilities, and patients who suffer from pathologies or take medications that cause gingival pigmentation were excluded from the study.\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\n \u003ch2\u003e2.2 Treatment Protocol\u003c/h2\u003e\n \u003cdiv id=\"Sec8\" class=\"Section3\"\u003e\n \u003ch2\u003e2.2.1 Preoperative preparations and instructions:\u003c/h2\u003e\n \u003cp\u003eAll Patients received non-surgical periodontal debridement two weeks before the depigmentation session and they were instructed to perform proper oral hygiene measures.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec9\" class=\"Section3\"\u003e\n \u003ch2\u003e2.2.2. TG: Ceramic soft tissue trimming bur (Cerabur) depigmentation:\u003c/h2\u003e\n \u003cp\u003eLocal anesthesia (Articaine with epinephrine 1:100:000, Laboratories Inibsa, Spain) was achieved by infiltration technique on the buccal aspect. Cerabur (Ceratip, Komet, USA.) was used in a high-speed handpiece without water coolant to remove the epithelial layer, excise and contour the gingival soft tissues. During the procedure, the gingiva as well as the Ceramic bur were cleaned from gingival debris with sterile gauze soaked with saline. Figure\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e\n \u003ch2\u003e2.2.3 CG: Conventional scalpel surgical scraping technique:\u003c/h2\u003e\n \u003cp\u003eLocal anesthesia was achieved in the same manner as TG. Followed by scraping of the pigmented gingival epithelium using no. 15 bard Parker blade. Care was taken to include the pigmented epithelium at the tip of the interdental papilla and at the muco-gingival junction on the other end. Hemostasis was obtained with sterile gauze and direct pressure. Figure\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e and Fig.\u0026nbsp;3.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec11\" class=\"Section3\"\u003e\n \u003ch2\u003e2.2.4 Postoperatively:\u003c/h2\u003e\n \u003cp\u003eAfter completing both procedures, the exposed surface was irrigated with saline and the surgical area was covered with a periodontal pack (COE-PAK, GC America) for 1 week for both groups. The patients were instructed to avoid hot and spicy food for 24 hours after surgery and to continue mechanical oral hygiene while avoiding the operated area. Ibuprofen 200 mg was prescribed immediately after surgery and the patients were advised to continue with the medication for 3 days after surgery if pain was experienced.\u003c/p\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n \u003ch2\u003e2.3 Assessment\u003c/h2\u003e\n \u003cp\u003eClinical assessment was done at baseline and after 1 week, 1 month, and 3 months. The assessed parameters included:\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003ePigmentation indices\u003c/strong\u003e:\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eDummet oral pigmentation index (DOPI): (Primary outcome)\u003c/strong\u003e the \u003cem\u003edegree\u003c/em\u003e of gingival pigmentation was scored as \u003cstrong\u003e0\u003c/strong\u003e: pink tissue; \u003cstrong\u003e1\u003c/strong\u003e: mild light brown tissue; \u003cstrong\u003e2\u003c/strong\u003e: medium brown or mixed brown and pink tissue; \u003cstrong\u003e3\u003c/strong\u003e: deep brown/ blue\u0026ndash;black tissue.\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eHedin melanin index (MI)\u003c/strong\u003e: the \u003cem\u003eextent\u003c/em\u003e of gingival pigmentation was scored as \u003cstrong\u003e0\u003c/strong\u003e: no pigmentation; \u003cstrong\u003e1\u003c/strong\u003e: one or two solitary units of pigmentation in the papillary gingiva; \u003cstrong\u003e2\u003c/strong\u003e: \u0026gt;3 units of pigmentation in the papillary gingiva without formation of a continuous ribbon; \u003cstrong\u003e3\u003c/strong\u003e: \u0026gt;1 short continuous ribbons of pigmentation; \u003cstrong\u003e4\u003c/strong\u003e: one continuous ribbon including the entire area between canines.\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eParameters of patient experience: (Secondary outcomes)\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eOperating time\u003c/strong\u003e:\u003c/p\u003e\n \u003cp\u003eThe time needed to complete each procedure was calculated in minutes by using a stopwatch from the time of the application of local anesthetic till the placement of the periodontal pack.\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003ePatient\u0026rsquo;s esthetic satisfaction\u003c/strong\u003e: was reported using the \u003cstrong\u003eGlobal Aesthetic Improvement Scale (GAIS)\u003c/strong\u003e where: \u003cstrong\u003e1\u003c/strong\u003e: Excellent improvement; \u003cstrong\u003e2\u003c/strong\u003e: Very improved; \u003cstrong\u003e3\u003c/strong\u003e: Improved; \u003cstrong\u003e4\u003c/strong\u003e: unaltered; \u003cstrong\u003e5\u003c/strong\u003e: worsened. The patients reported their degree of satisfaction with the aesthetic outcome of the procedure 1 month postoperatively.\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003ePain perception\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003ewas reported using \u003cstrong\u003eVisual Analogue Scale (VAS)\u003c/strong\u003e at 24 hours, 2 days, 3\u0026ndash;5 days, and 7 days post-operatively. (Zero is for minimum pain and ten is for maximum pain). The patients were asked to keep a diary of the perceived pain levels as well as their analgesic consumption if any.\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e2.4 Data management and Statistical analysis\u003c/strong\u003e: Numerical data were presented as mean and standard deviation values. They were analyzed for normality using Shapiro-Wilk\u0026rsquo;s test. Data were non-parametric and were analyzed using Friedman\u0026rsquo;s test followed by Nemenyi post hoc test. The significance level was set at \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 within all tests. Statistical analysis was performed with R statistical analysis software version 4.3.0 for Windows\u003csup\u003e2\u003c/sup\u003e.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"3. Results","content":"\u003cp\u003eThe study was conducted on 8 patients 2 (25%) males and 6 (75%) females with a mean age of (23.88\u0026thinsp;\u0026plusmn;\u0026thinsp;2.85) years. All the included participants have met the eligibility criteria and received both treatment and control interventions on either arch depending on the randomization. Figure\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e\u003c/p\u003e\n\u003cdiv class=\"BlockQuote\"\u003e\n\u003cp\u003e\u003cstrong\u003e3.1 Clinical outcomes: Dummet oral pigmentation index (DOPI)\u003c/strong\u003e: for \u003cem\u003eboth groups\u003c/em\u003e \u003cstrong\u003eTG \u0026amp; CG\u003c/strong\u003e there was a significant difference between values measured at different intervals (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). The highest value was found at baseline (2.25\u0026thinsp;\u0026plusmn;\u0026thinsp;0.71), followed by 3 months (0.12\u0026thinsp;\u0026plusmn;\u0026thinsp;0.35), while the lowest value was found at 1 month (0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00). Post hoc pairwise comparisons showed the baseline to have a significantly higher value than values measured at other intervals (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Table\u0026nbsp;(1).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTable (1) Inter and intragroup comparisons, mean and standard deviation (SD) values for VAS for both groups (Values with different superscript letters within the same vertical column are significantly different *; significant (p \u0026le; 0.05) ns; non-significant (p\u0026gt;0.05))\u003c/em\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Taba\" border=\"1\"\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth rowspan=\"2\" align=\"left\"\u003e\n\u003cp\u003eTime\u003c/p\u003e\n\u003c/th\u003e\n\u003cth colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003eDOPI (Mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth rowspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e\u003cem\u003eP\u003c/em\u003e-value\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eTest\u003c/strong\u003e\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eControl\u003c/strong\u003e\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eBaseline\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2.25\u0026thinsp;\u0026plusmn;\u0026thinsp;0.71\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2.25\u0026thinsp;\u0026plusmn;\u0026thinsp;0.71\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e1ns\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1 month\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e1ns\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3 months\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.12\u0026thinsp;\u0026plusmn;\u0026thinsp;0.35\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.12\u0026thinsp;\u0026plusmn;\u0026thinsp;0.35\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e1ns\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ep-value\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026lt;\u0026thinsp;0.001*\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026lt;\u0026thinsp;0.001*\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cstrong\u003eHedin melanin index (MI)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe percentage change in MI at different intervals was \u003cstrong\u003eCG\u003c/strong\u003e (93.75\u0026thinsp;\u0026plusmn;\u0026thinsp;17.68) had a higher value than \u003cstrong\u003eTG\u003c/strong\u003e (89.58\u0026thinsp;\u0026plusmn;\u0026thinsp;14.60), when comparing baseline to 1 month and \u003cstrong\u003eTG\u003c/strong\u003e (80.21\u0026thinsp;\u0026plusmn;\u0026thinsp;22.69) had a higher value than \u003cstrong\u003eCG\u003c/strong\u003e (77.08\u0026thinsp;\u0026plusmn;\u0026thinsp;28.43) when comparing baseline to 3 months. Both differences were statistically insignificant (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.854) for baseline to 1 month and (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.812) for baseline to 3 months. Inter and intra group comparisons of MI scores are shown in table (2)\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTable 2 Inter and intragroup comparisons, mean and standard deviation (SD) values for MI for both groups at different time intervals (Values with different superscript letters within the same vertical column are significantly different *; significant (p \u0026le; 0.05) ns; non-significant (p\u0026gt;0.05)\u003c/em\u003e\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab1\" border=\"1\"\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth rowspan=\"2\" align=\"left\"\u003e\n\u003cp\u003eTime\u003c/p\u003e\n\u003c/th\u003e\n\u003cth colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003eHEDIN Melanin index (Mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth rowspan=\"2\" align=\"left\"\u003e\n\u003cp\u003ep-value\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eTest\u003c/strong\u003e\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eControl\u003c/strong\u003e\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eBaseline\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3.75\u0026thinsp;\u0026plusmn;\u0026thinsp;0.46\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3.75\u0026thinsp;\u0026plusmn;\u0026thinsp;0.46\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e1ns\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1 month\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.38\u0026thinsp;\u0026plusmn;\u0026thinsp;0.52\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.25\u0026thinsp;\u0026plusmn;\u0026thinsp;0.71\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e0.850ns\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3 months\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.75\u0026thinsp;\u0026plusmn;\u0026thinsp;0.89\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.88\u0026thinsp;\u0026plusmn;\u0026thinsp;1.13\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e1ns\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ep-value\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026lt;\u0026thinsp;0.001*\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026lt;\u0026thinsp;0.001*\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cstrong\u003e3.2 Patient experience: Operating time: CG\u003c/strong\u003e (13.88\u0026thinsp;\u0026plusmn;\u0026thinsp;3.56) had a higher value than \u003cstrong\u003eTG\u003c/strong\u003e (13.75\u0026thinsp;\u0026plusmn;\u0026thinsp;2.12), yet the difference was not statistically significant (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.925). Figure\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e5\u003c/span\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatients\u0026rsquo; esthetic satisfaction (GAIS)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCG (2.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.76) had a higher value than TG (1.88\u0026thinsp;\u0026plusmn;\u0026thinsp;0.64), yet the difference was not statistically significant (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.766). Figure\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e6\u003c/span\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePain perception (VAS): CG\u003c/strong\u003e had higher pain values than \u003cstrong\u003eTG\u003c/strong\u003e on day 1, day 2 and day 3\u0026ndash;5 yet the difference was not statistically significant (p\u0026thinsp;=\u0026thinsp;0.169), (p\u0026thinsp;=\u0026thinsp;0.752), (p\u0026thinsp;=\u0026thinsp;0.571) respectively. 1 week post operatively only one patient in the \u003cstrong\u003eTG\u003c/strong\u003e reported residual pain, while no one reported pain in the \u003cstrong\u003eCG\u003c/strong\u003e. The difference was not statistically significant (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;1). Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTable 3 Inter and intragroup comparisons, mean and standard deviation (SD) values for VAS for both groups (Values with different superscript letters within the same vertical column are significantly different *; significant (P \u0026le; 0.05) ns; non-significant (P\u0026gt;0.05))\u003c/em\u003e\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab2\" border=\"1\"\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth rowspan=\"2\" align=\"left\"\u003e\n\u003cp\u003eTime\u003c/p\u003e\n\u003c/th\u003e\n\u003cth colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003eVAS (Mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth rowspan=\"2\" align=\"left\"\u003e\n\u003cp\u003ep-value\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eTest\u003c/strong\u003e\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eControl\u003c/strong\u003e\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eday 1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1.88\u0026thinsp;\u0026plusmn;\u0026thinsp;2.42\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3.38\u0026thinsp;\u0026plusmn;\u0026thinsp;2.00\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e0.169ns\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eday 2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2.50\u0026thinsp;\u0026plusmn;\u0026thinsp;2.56\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3.12\u0026thinsp;\u0026plusmn;\u0026thinsp;1.81\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e0.752ns\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eday 3\u0026ndash;5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1.25\u0026thinsp;\u0026plusmn;\u0026thinsp;1.58\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1.62\u0026thinsp;\u0026plusmn;\u0026thinsp;1.19\u003csup\u003eab\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e0.571ns\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1 week\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.12\u0026thinsp;\u0026plusmn;\u0026thinsp;0.35\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.00\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e1ns\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ep-value\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e0.062ns\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026lt;\u0026thinsp;0.001*\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eThis RCT aimed to compare both techniques regarding clinical outcomes, pain perception, patient satisfaction, and stability of the results. To the best of our knowledge, there are no published clinical trials to compare the outcomes of gingival depigmentation by ceramic soft tissue trimming bur with the surgical stripping technique.\u003c/p\u003e\n\u003cp\u003eThe scalpel technique is still a gold standard in gingival depigmentation. The popularity of the scalpel technique is owed to its efficiency, affordability, and simplicity. However, this technique has the drawbacks of a bloody field of surgery, probable infections, and a high rate of recurrence(\u003cspan class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e). Cerabur was selected in this study as a novel and promising technique for gingival depigmentation that shares the affordability and ease of use of the surgical stripping technique with the additional benefit of good hemostasis and cleanliness of the operating field (\u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eThe study was conducted in a split-mouth fashion (\u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e). This design was selected to evade the inter-subject variables such as age, facial complexion, genetics, and environmental risk factors. The inter-subject variables could induce bias in the estimated treatment effect and the pain perception of the individual (\u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e). The decision to employ the arches design over the quadrant design was to avoid color disparity in the same arch which might be dissatisfactory to the patient. Carry-over effects may induce bias in split-mouth RCTs(\u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e). Consequently, in this study one dental arch of each patient was treated according to the assigned randomization and the opposing arch was not treated until the patient reported no pain (0 on VAS).\u003c/p\u003e\n\u003cp\u003ePeriodontal pack placement is not mandatory. However, there are multiple benefits to applying a periodontal pack post-surgically including less post-operative pain score reported by the patients and slightly better healing (\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e). Application of a periodontal pack after both procedures in accordance with previous studies (\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eDOPI, as well as MI pigmentation indices, were both used to attain more accurate results as DOPI is based on the color intensity of the gingival pigmentation whereas MI is based on the extent and the distribution of the pigments. Previous studies \u003cstrong\u003ehave\u003c/strong\u003e used two pigmentation indices for the same reason.(\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e)\u003c/p\u003e\n\u003cp\u003eThe results of the present study showed a statistically significant reduction in DOPI values in both groups from baseline. \u003cstrong\u003eGholami et al., 2018\u003c/strong\u003e compared surgical stripping and ErCr: YSGG (Erbium, chromium-doped yttrium, scandium, gallium, and garnet) Laser depigmentation and \u003cstrong\u003eNegi et al., 2019\u003c/strong\u003e compared cerabur and diode laser depigmentation. They both reported a significant decrease in pigmentation indices from baseline (\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eThe percentage change in MI was different for both groups with the cerabur having lower value when comparing baseline to 1 month and higher values when comparing baseline to 3 months. This shows better initial clinical outcomes of the surgical stripping technique and superior stability of the cerabur results. However, the difference was not statistically significant.\u003c/p\u003e\n\u003cp\u003eThese findings were analogous to the findings of \u003cstrong\u003eGholami et al., 2018\u003c/strong\u003e who found no difference between the recurrence rates of scalpel and ErCr: YSGG laser(\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e). However, they are in contrast with \u003cstrong\u003ePenmetsa et al., 2019\u003c/strong\u003e who found significantly higher recurrence rates with scalpel depigmentation when compared to cryosurgery(\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eGingival re-pigmentation after depigmentation is one of the drawbacks of the procedure. It is hypothesized that gingival re-pigmentation occurs due to the migration of neighboring melanocytes. The re-pigmentation rate of the two techniques was measured at the end of the follow-up period, 3 months post-operative, to compare the stability of the results(\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e23\u003c/span\u003e). DOPI and MI baseline values were the highest followed by 3 months, then 1 month. This is due to the re-appearance of some pigments in the form of spots, dots, or stria in some of the subjects at the 3 months assessment visit (\u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eVAS was employed to evaluate the patients\u0026rsquo; perception of pain in each arch due to its simplicity and reliability(\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e). There was no statistically significant difference between patient-reported VAS scores. These results were in contrast with \u003cstrong\u003eNegi et al., 2019\u003c/strong\u003e who found significantly more pain in sites treated with cerabur compared to diode laser(\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e). The pain levels in this study were comparable to previous studies(\u003cspan class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e) that reported more pain in sites treated with scalpel compared to laser and aligned with studies(\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e) that didn\u0026rsquo;t find any significant difference in pain levels when comparing lasers with surgical scalpel. The frictional heat of the cerabur caused tissue coagulation and minimal bleeding. The localized heat causes coagulation, protein denaturation, drying, vaporization, and carbonization. As a result, blood vessels and sensory nerve endings are sealed. This may explain the faintly lower pain levels in the cerabur sites compared with the scalpel sites(\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e27\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eGAIS was adopted from plastic surgery and cosmetic literature(\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e29\u003c/span\u003e) to measure the patient\u0026rsquo;s level of satisfaction with the aesthetic outcome. Cerabur had better patient satisfaction scores. More patients appreciated the less invasive and less bloody nature of the cerabur procedure over the scalpel surgery.\u003c/p\u003e"},{"header":"5. Conclusion","content":"\u003cp\u003eClinical performance of cerabur and scalpel was similar while the overall patient experience (Pain, Esthetic satisfaction, and treatment time) was in favor of the cerabur. Cerabur depigmentation is an effective, bloodless, easy-to-perform technique that does not require sophisticated armamentarium. Cerabur depigmentation is a practical substitute for the standard scalpel stripping technique.\u003c/p\u003e"},{"header":"6. Recommendations","content":"\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eMore clinical trials of bigger sample size and longer follow up periods are needed to further evaluate the efficacy and stability of results of the ceramic soft tissue trimmer in depigmentation of the gingiva.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eFurther research comparing the ceramic soft tissue trimmer with other depigmentation techniques.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eHistological studies should be done to further understand the mechanism of re-pigmentation.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"7. List of abbreviations","content":"\u003cp\u003eCerabur: Ceramic soft tissue trimming bur.\u003c/p\u003e\n\u003cp\u003eTG: Test group\u003c/p\u003e\n\u003cp\u003eCG: Control group\u003c/p\u003e\n\u003cp\u003eDOPI: Dummet oral pigmentation index\u003c/p\u003e\n\u003cp\u003eMI: Melanin Index\u003c/p\u003e\n\u003cp\u003eRCT: Randomized controlled trial.\u003c/p\u003e\n\u003cp\u003eASA: American Academy of Anesthesiologists\u003c/p\u003e\n\u003cp\u003eGAIS: Global Aesthetic improvement scale\u003c/p\u003e\n\u003cp\u003eVAS: Visual analogue scale\u003c/p\u003e\n\u003cp\u003eErCr: YSGG: Erbium, chromium-doped yttrium, scandium, gallium, and garnet\u003c/p\u003e"},{"header":"8. Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis study was approved by the Ethics Committee, Faculty of Dentistry, Ain Shams University (FDASU-Rec012124) and performed in accordance with the Declaration of Helsinki. Informed consent was obtained from all subjects and/or their legal guardian(s).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u003c/strong\u003e not applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials:\u003c/strong\u003e The data supporting the findings of this study are available upon request from the corresponding author.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u003c/strong\u003e The authors declare no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e There was no funding provided to the authors by any organization\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors contributions:\u003c/strong\u003e SN: Conceptualization, Methodology, Investigation, Resources, Data Curation, Writing- Original draft preparation. HA: Conceptualization, Methodology, Writing- Review \u0026amp; Editing, Supervision. YA: Methodology, Data curation, Writing- Review \u0026amp; Editing.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgment:\u003c/strong\u003e not applicable\u003c/p\u003e"},{"header":"References","content":"\u003col class=\"decimal_type\"\u003e\n\u003cli\u003eKamboj S and Salaria S (2020) Efficacy of liquid nitrogen and electrocautery assisted gingival depigmentation in term of patient\u0026rsquo;s perception, histological wound healing - A randomized triple blind clinical trial. J Indian Soc Periodontol. 24(2): 135\u0026ndash;144. https://doi.org/10.4103/jisp.jisp_438_19.\u003c/li\u003e\n\u003cli\u003eSingh M (2018) Esthetic Management of Gingival Melanin Hyperpigmentation by 810 nm Diode Laser. Open Access J. Dent. Sci. 3(7). https://doi.org/10.23880/oajds-16000196.\u003c/li\u003e\n\u003cli\u003eEl-Mofty M, Elkot S, Ghoneim A, Yossri D, and Ezzatt OM. (2021) Vitamin C mesotherapy versus topical application for gingival hyperpigmentation: a clinical and histopathological study. Clin Oral Investig. 25(12):6891. https://doi.org/10.1007/s00784-021-03978-6.\u003c/li\u003e\n\u003cli\u003eChaudhary DS, Parwani S, Barkhade S, et al. (2023) Physiological Gingival Melanin Hyperpigmentation Treatment with Injectable Vitamin C and Scalpel Technique: A Randomised Controlled Clinical Trial. Int J Dent. 2023: 4586923. https://doi.org/10.1155/2023/4586923.\u003c/li\u003e\n\u003cli\u003eALasmari Dhafer S (2018) An insight into gingival depigmentation techniques: The pros and cons,\u0026rdquo; Int J Health Sci (Qassim). 12(5): 84\u0026ndash;89. PMCID: PMC6124824.\u003c/li\u003e\n\u003cli\u003eNegi R, Gupta R, Dahiya P, Kumar M, Bansal, and Samlok JK (2019) Ceramic soft tissue trimming bur: A new tool for gingival depigmentation. J Oral Biol Craniofac Res. 9(1): 14\u0026ndash;18. https://doi.org/10.1016/j.jobcr.2018.07.002.\u003c/li\u003e\n\u003cli\u003eGarg R, Mattoo KA, and Jain P (2015) Aesthetic treatment for hyperpigmented gingiva. Int. j. res. med. sci. technol. 1(1). https://www.researchgate.net/publication/271700831.\u003c/li\u003e\n\u003cli\u003eGoldar K, Chaubey KK., Agarwal S, and Agarwal T (2020) GINGIVAL DEPIGMENTATION BY GINGIVAL CERAMIC TRIMMER-A CASE SERIES. https://www.academia.edu/48868052/Gingival_Depigmentation_by_Gingival_Ceramic_Trimmer.\u003c/li\u003e\n\u003cli\u003eChhina S, Gakhar A, Gupta S, et al. (2019) Assessment of Clinical Outcomes and Patient Response to Gingival Depigmentation by Scalpel Surgical Stripping and Diode Laser: A Randomized Split-Mouth Study,\u0026rdquo; J Adv Oral Res. 10(1):13\u0026ndash;18. https://doi.org/10.1177/2320206818820995.\u003c/li\u003e\n\u003cli\u003eChandra GB, VinayKumar MB, Walavalkar NN, Vandana KL, and Vardhan PK (2020) Evaluation of surgical scalpel versus semiconductor diode laser techniques in the management of gingival melanin hyperpigmentation: A split-mouth randomized clinical comparative study. J Indian Soc Periodontol. 24(1):47-53. https://doi.org/10.4103/jisp.jisp_186_19.\u003c/li\u003e\n\u003cli\u003eHaryo HM, Djais AI, and Adam AM (2020) The comparison of some depigmentation techniques towards reccurence of gingival hyperpigmentation: a systematic review. Makassar Dent. J., 9(2):114\u0026ndash;117. https://doi.org/10.35856/mdj.v9i2.329.\u003c/li\u003e\n\u003cli\u003eInasu S, Thomas B. (2021) A Pink Smile: Depigmentation Using Diode Laser and Surgical Scalpel. Int J Experiment Dent Sci. 10 (1):41-44. https://doi.org/10.5005/jp-journals-10029-1224\u003c/li\u003e\n\u003cli\u003eHassan S, Dhadse P, Bajaj P, et al. (2022) A Comparison Between the Efficacy of Scalpel and Laser Procedures for Treating Gingival Hyperpigmentation: A Case Report. Cureus 14(8): e27954. https://doi.org/10.7759/cureus.27954.\u003c/li\u003e\n\u003cli\u003eRoshannia B, Nourelahi M, Ahmadpanahi T, Norouzifard A, and Kojoori SS (2021) Comparison of Bur Abrasion and CO2 Laser in Treatment of Gingival Pigmentation: 6 Months Follow-Up. Oral Health Prev Dent 2021; 19: 321\u0026ndash;326. https://doi.org/10.3290/j.ohpd.b1492771.\u003c/li\u003e\n\u003cli\u003eZhu H, Zhang S, and Ahn C (2017) Sample size considerations for split-mouth design. Stat Methods Med Res.26(6):2543-2551. https://doi.org/10.1177/0962280215601137.\u003c/li\u003e\n\u003cli\u003eSma\u0026iuml;l-Faugeron V, Fron-Chabouis H, Courson F, and Durieux P (2014) Comparison of intervention effects in split-mouth and parallel-Arm randomized controlled trials: A meta-epidemiological study. BMC Med Res Methodol 14, 64 (2014). https://doi.org/10.1186/1471-2288-14-64.\u003c/li\u003e\n\u003cli\u003eSoheilifar S, Bidgoli M, Faradmal J, Soheilifar S, and Bidgoli M (2015) Effect of Periodontal Dressing on Wound Healing and Patient Satisfaction Following Periodontal Flap Surgery. J Dent (Tehran). 2015 Feb; 12(2): 151\u0026ndash;156. PMCID: PMC4434129\u003c/li\u003e\n\u003cli\u003eKathariya R, Jain H, and Jadhav T (2015) To pack or not to pack: The current status of periodontal dressings. J Appl Biomater Funct Mater. 2015 Jul 4;13(2):73-86. https://doi.org/10.5301/jabfm.5000215.\u003c/li\u003e\n\u003cli\u003eKarthik EVG, Kaarthikeyan G, and Ganapathy D (2021) Gingival depigmentation techniques: A review. Int J Dentistry Oral Sci. 2021;8(7):2946-2949. https://doi.org/10.19070/2377-8075-21000598.\u003c/li\u003e\n\u003cli\u003eRaghavendra RN, Ragul M, Nabeeh AQ, Ravi KS, Tikare S, and Pasupuleti MS (2017) Clinical Effectiveness of Gingival Depigmentation Using Conventional Surgical Scrapping and Diode Laser Technique: A Quasi Experimental Study. Glob J Health Sci. 9(3):296. https://doi.org/10.5539/gjhs.v9n3p296.\u003c/li\u003e\n\u003cli\u003eGholami L, Moghaddam S, Ladiz M et al. (2018) Comparison of gingival depigmentation with Er,Cr:YSGG laser and surgical stripping, a 12-month follow-up. Lasers Med Sci. 33(8):1647-1656. https://doi.org/10.1007/s10103-018-2501-1.\u003c/li\u003e\n\u003cli\u003ePenmetsa G, Mopidevi A, Dwarakanath C, and Raju M (2019) Melanocyte response following depigmentation by cryosurgery and mucosal excision: A comparative clinical and histopathological study. Contemp Clin Dent. 10(2): 214\u0026ndash;219. https://doi.org/10.4103/ccd.ccd_364_18.\u003c/li\u003e\n\u003cli\u003eBakutra G, Shankarapillai R, Mathur L, and Manohar B (2017) Comparative evaluation of diode laser ablation and surgical stripping technique for gingival depigmentation: A clinical and immunohistochemical study. Int J Health Sci (Qassim). 11(2): 51\u0026ndash;58. PMCID: PMC5426409\u003c/li\u003e\n\u003cli\u003eKaur H, Jain S, and Sharma RL (2010) Duration of reappearance of gingival melanin pigmentation after surgical removal - A clinical study. J Indian Soc Periodontol. 14(2):101-5. https://doi.org/10.4103/0972-124X.70828.\u003c/li\u003e\n\u003cli\u003ePrice DD, McGrath PA, Rafii A, and Buckingham B (1983) The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 17(1):45-56. https://doi.org/10.1016/0304-3959(83)90126-4.\u003c/li\u003e\n\u003cli\u003eJagannathan R, Rajendran S, Balaji TM, Varadarajan S, and Sridhar LP (2021) Comparative Evaluation of Gingival Depigmentation by Scalpel, Electrosurgery, and Laser: A 14 Months\u0026rsquo; Follow-up Study. J Contemp Dent Pract. 1;21(10):1159-1164. https://doi.org/10.5005/JP-JOURNALS-10024-2934.\u003c/li\u003e\n\u003cli\u003eSobouti F, Rakhshan V, Chiniforush N, and Khatami M (2014) Effects of laser-assisted cosmetic smile lift gingivectomy on postoperative bleeding and pain in fixed orthodontic patients: A controlled clinical trial. Prog Orthod. 15(1):66. https://doi.org/10.1186/s40510-014-0066-5.\u003c/li\u003e\n\u003cli\u003eSavoia, A., Accardo, C., Vannini F. et al. (2014) Outcomes in Thread Lift for Facial Rejuvenation: A Study Performed with Happy Lift\u0026trade; Revitalizing. Dermatol Ther. \u003cstrong\u003e4\u003c/strong\u003e, 103\u0026ndash;114. https://doi.org/10.1007/s13555-014-0041-6.\u003c/li\u003e\n\u003cli\u003ePrantl L, Brix E, Kempa S et al. (2021) Facial rejuvenation with concentrated lipograft\u0026mdash;a 12-month follow-up study. Cells, 10,3, 594; https://doi.org/10.3390/cells10030594.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Footnotes","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eFaul, Franz, et al. \"G* Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences.\" \u003cem\u003eBehavior research methods\u003c/em\u003e 39.2 (2007): 175\u0026ndash;191.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eR Core Team (2023). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.R-project.org/\u003c/span\u003e\u003cspan address=\"https://www.R-project.org/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\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":"Ceramic bur, Ceramic soft tissue trimmer, Scalpel, Melanin Hyperpigmentation, Gingival Depigmentation, periodontal surgery","lastPublishedDoi":"10.21203/rs.3.rs-3943266/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3943266/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eCeramic soft tissue trimming bur (Cerabur) was primarily launched to be used in gingivoplasty but has been used recently in gingival depigmentation. This study aimed to compare the efficacy of depigmentation using the novel cerabur versus the gold-standard surgical scalpel technique.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eEight healthy, non-smokers with moderate to severe gingival hyperpigmentation in both arches were randomly assigned for cerabur depigmentation in one arch as a test group (TG) and scalpel depigmentation in the opposite arch as a control group (CG). Pigmentation indices were used to assess the clinical outcome. Treatment time, pain levels, and esthetic satisfaction were the parameters of patient experience. The assessment was done at baseline, 1 week, 1 month, and 3 months.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eAt all the assessment visits, the pigmentation intensity represented by Dummet oral pigmentation index (DOPI), and distribution represented by Hedin melanin index (MI) were significantly less than baseline (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001) in both groups. When comparing both groups, Scalpel depigmentation had better initial clinical outcomes, while Cerabur had less visible re-pigmentation, pain Scores, and treatment time, along with more esthetic satisfaction. However, all these differences were not statistically significant.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eBoth techniques successfully removed the gingival hyperpigmentation with comparable clinical outcomes. Cerabur depigmentation was favored by the patients.\u003c/p\u003e\u003ch2\u003eTrial registration:\u003c/h2\u003e \u003cp\u003eThe study protocol was registered on 11/09/2023 on the \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e\u003ca href=\"http://www.clinicaltrials.gov\" target=\"_blank\"\u003ewww.clinicaltrials.gov\u003c/a\u003e\u003c/span\u003e\u003cspan address=\"http://www.clinicaltrials.gov\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e database (NCT06031116) after the approval of the Ethics Committee, Faculty of Dentistry, Ain Shams University (FDASU-Rec012124).\u003c/p\u003e","manuscriptTitle":"Ceramic Soft Tissue Trimming Bur Gingival Depigmentation: Clinical Performance and Patient Experience. “A Split Mouth Randomized Controlled Trial”","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-03-05 16:23:44","doi":"10.21203/rs.3.rs-3943266/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-03-22T05:14:13+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-03-14T21:28:40+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"05eb9624-2369-428e-9487-415de8967570","date":"2024-03-14T16:50:47+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"5089dd4b-d9dc-412f-9e48-a988003bf9d1","date":"2024-03-03T18:21:56+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-03-03T14:19:11+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-03-03T14:07:23+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2024-03-01T09:37:43+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-03-01T08:52:33+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Oral Health","date":"2024-02-09T14:14:18+00:00","index":"","fulltext":""}],"status":"published","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}}],"origin":"","ownerIdentity":"008bd237-d5de-419e-bf1c-49bd231ac8ae","owner":[],"postedDate":"March 5th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2024-05-07T11:35:43+00:00","versionOfRecord":[],"versionCreatedAt":"2024-03-05 16:23:44","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3943266","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3943266","identity":"rs-3943266","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}