Comparison of patient adaptation with in-office aligners with two different levels of the gingival margin

Comparison of patient adaptation with in-office aligners with two different levels of the gingival margin | 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 Article Comparison of patient adaptation with in-office aligners with two different levels of the gingival margin Eduardo Terumi Blatt Ohira, Tiago Fialho, Samira Salmeron, Karina Maria Salvatore de Freitas, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6784996/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective: This prospective clinical study compared the overall patient perception and periodontal health using in-office clear aligners with two gingival margin level heights (gingival level and 2 mm up to the gingival level). Material and Methods: The sample comprised 23 patients treated with in-office clear aligners. The mean age was 28.74 years. The mean initial maxillary and mandibular irregularity indexes were 3.95 and 3.66mm, respectively. Twelve patients started using 2 pairs of aligners trimmed at the gingival margin level (0mm), and 11 patients using 2 pairs of aligners trimmed 2 mm above the gingival margin level. Each set of aligners was used for 14 days. The total evaluation time was 2 months. The Gingival Index Bleed was performed at the end of the use of each type of aligner. On Google Forms, patients answered a 9-item questionnaire about their perception of comfort, adaptation, speech, and swallowing while using the 2 aligners. The Wilcoxon test was used to compare the questionnaire grades. Dependent t-test compared the G.I. Descriptive statistics were used to determine aligner preference. Results: There was no statistically significant difference between the two heights of gingival margin levels in the nine evaluated items. Most patients preferred the 0mm, with comfort and adaptation as the main reason for the choice Those who opted for gingival margin height up to 2 mm mentioned good fit, adaptation, and retention as the main reasons. Conclusion: The patient's perception was similar for speaking, cleaning, esthetics, fit, and retention with the 2 evaluated heights. However, most of the patients preferred the aligners trimmed at the gingival level. Health sciences/Health care/Dentistry/Orthodontics Health sciences/Health care/Quality of life Orthodontics Malocclusion Orthodontic Appliances Removable Figures Figure 1 Figure 2 Figure 3 Figure 4 INTRODUCTION Clear aligner therapy (CAT) has become a popular and well-accepted alternative for orthodontic treatments. 1 , 2 With the increasing popularity of the digital workflow, the possibility of producing aligners in private dental offices is a reality for many orthodontists. 3 Invisalign's clear aligners have led to more companies offering similar services to orthodontists. But these services can be more expensive and have varying delivery times and fees. 4 In-office aligners are faster and cheaper and allow orthodontists to customize the orthodontic treatment at every stage. 5 There is no standard for manufacturing clear aligners, as each company follows its recommendation regarding the material, thickness, and gingival margin of the aligners. 6 – 9 Clear aligners can feature a scalloped or straight cut margin at the gingival level, ranging from 0 to 2mm above it. 10 The Invisalign system is the most used commercial clear aligner system worldwide. 6 More than 90% of research is carried out with Invisalign. 8 Currently, the company cut their aligners with a scalloped gingival margin. 6 , 11 The ideal gingival margin level for in-office aligners is unclear. In vitro studies favor straight margins over those trimmed at 2mm or less. 12 , 13 Despite the studies that evaluated CAT, 14 – 16 almost none specify the height of the marginal level at which this aligner was manufactured. 17 , 18 . Studies on the size and design of the gingival margin of the aligners are primarily in vitro , 12 , 13 and the patient's perception is underestimated. Therefore, evaluating the perception of comfort, retention, and gingival health becomes essential for the orthodontist to decide how to trim the in-office aligner. In this context, This study aims to compare patient adaptation and periodontal health outcomes between in-office clear aligners with different gingival margin cuts: at the gingival level and extending 2mm above the gingival margin. MATERIAL AND METHODS This prospective study was approved by the Ethics Research Committee of Ingá University Center (under # 51507321.9.0000.5220; Annex II). All methods were performed in accordance with the relevant guidelines and regulations. Written informed consent was obtained before the patients were randomized into the treatment groups. The sample size calculation was based on an alpha significance level of 5% (0.05) and a beta of 20% (0.20) to reach a test power of 80% and detect a minimum difference of 2 points with a standard deviation 2.19 for a numerical scale indicating comfort. 19 The minimum sample required was 20 patients. Participants, eligibility criteria, and settings This prospective study was conducted from June/21 to June/22, and the sample selection was carried out in a private clinic in ________________. Inclusion criteria were patients of both sexes aged 18 to 45 years; all erupted permanent teeth up to first molars, Class I malocclusion, and mild to moderate anterior crowding. Patients who fit the inclusion criteria were invited to participate, and all patients filled out an informed consent form. All patients were treated with in-office clear aligners produced in partnership with Contraste Radiology (Contraste, Blumenau, SC, Brazil). Before treatment, all orthodontic digital planning with the OrthoAnalyzer software (3Shape, Copenhagen, Denmark) was performed by the same professional (ETBO). The Cases received prescribed attachments and interproximal reduction as prescribed, without any accessory mechanics. Even though attachments may directly influence retention 20 , aesthetics 21 , and adaptability 22 of the aligners, specially in situations where the gingival-level trimming is lower, all participants used the same attachments in both samples of aligners for this study. Attachments were placed accordingly to their needs and requirements for their individual treatment, so it would not interfere as a bias for this study. All patients received instructions on a standardized oral hygiene protocol. The final sample comprised 23 patients (17 women and 6 men) with a mean age of 28.74 ± 6.8. The mean initial maxillary and mandibular irregularity indexes were 3.95mm (1.5mm) and 3.66mm (2.16mm). The mean number of initial attachments was 1.91 (3.38mm). All patients used the 2 pairs of aligners with a straight cut at the gingival level (Fig. 1 A) and 2 pairs with a straight cut aproximatelly 2mm above the gingival level (Fig. 1 B). Half of the sample started using the 0mm aligners, and the other half used the 2mm. Patients were advised to wear their aligners 20 hours a day and to change each set every 15 days. The total treatment time for each sequence of aligners was 1 month. A one-month washout period was implemented between the use of aligners with different gingival margin levels. At the end of 1 month, the patients received their subsequent aligner with a different marginal cut. All aligners were made with 0.8mm PET-G (Forestadent Track-A, Germany), using a pressure thermoforming (Drufosmart D3200, Drevem, Germany), and the cutting and polish were performed manually with disks and cutters (DhPro, Kit Paschotto & Ohira, Brazil) by the same professional (ETBO). Questionnaire Immediately after using each pair of aligners, the patients answered on Google forms a closed questionnaire to assess their perception regarding using the 2 types of aligners. In the questionnaire, based on a previous study that evaluated comfort, 19 nine items were evaluated (adaptability, speech, swallowing, soft tissue comfort, overall satisfaction, cleaning, aesthetics, durability, fitting, and retention. The patient scored 0–10, with 0 being poor and 10 excellent. After completing the two research phases, the patients answered a final comparative questionnaire to choose the aligners with their preferred gingival margin edges. They explained the reasons for the last open question. The data were uploaded to Excel (Microsoft Office 365, Redmond, USA). The questionnaire workflow can be seen in Fig. 2 . The Gingival Index Bleed (G.I.) was evaluated at pretreatment and at the end of each aligner sequence by the same operator (ETBO) to assess periodontal health. The G.I. was evaluated according to Loe's methodology. 23 Statistical analysis The normality of the data was evaluated using the Shapiro-Wilk test. The comparison between the grades received for each item from the questionnaire was performed using the Wilcoxon test. The difference between the G.I. for each gingival margin was performed with dependent t-test. Descriptive statistics were used to determine the preference between aligners, and descriptive statistics and percentage comparison were used to assess the reasons that led patients to choose the gingival margin. All statistical analyses were performed using the Statistica software for Windows (Version 10.0; StatSoft, Tulsa, Okla) and were considered significant when p < 0.05. RESULTS During recruitment, 32 patients were assessed for eligibility. However, 6 were excluded for not meeting the inclusion criteria. Twenty-six patients participated in the research. Three patients dropped out of treatment during follow-up and were removed from the study (Fig. 3 ). There was no statistically significant difference regarding the nine evaluated items between the 0mm and 2mm aligners (Table I). The 0mm gingival margin was chosen for 69.57% of the patients (Table II). The most mentioned reasons were: comfort, adaptation, and aesthetics (Fig. 4 A). Those who opted for the 2mm aligner said good fit, adaptation, and retention as the main reasons (Fig. 4 B). There was no significant difference in G.I. after using the 0mm or 2mm aligners (Table III). Harms No harm was observed in patients (e.g., fractures, injuries); patients were advised to stop using aligners if allergies occurred. No allergic reactions occurred, and Aligners were discarded after treatment. DISCUSSION All patients wore each type of aligner for one month. After using two pairs of aligners for one month, a one-month washout period was implemented before using the next set of aligners with a different gingival height. This was necessary to ensure accurate evaluation of the same patient without influence from the previous aligner with a different gingival cut height. The progressive replacement regimen was recommended every 15 days and agrees with the current orthodontic literature. 18 , 24 – 26 According to Chagas et al. 19 one month of use is enough for patients to assess their satisfaction and adaptation to the device. Half of the sample started using 0mm aligners and the other half 2 mm to avoid bias caused by the first aligner's experience influencing the second's perception. All patients used both types of aligners. In addition, little's irregularity index at the beginning of treatment was small. Therefore, the degree of crowding, associated with a low rate of movement per aligner, may not have interfered with the comparison. It is essential to highlight that the objective of our study was not to evaluate the correction of the malocclusion but only the patient's perception during the use of the aligners. To assess the patient's perception of the characteristics of each type of aligner, we used a questionnaire based on the study of Chagas et al. 19 . It may be considered a study limitation because the questionnaire was not validated. However, the questions used allowed a more accurate assessment of patients concerning specific aspects, such as perception of fit and retention of the aligner. Pogal-Sussman-Gandia et al. 26 also used a non-validated questionnaire in their study about the effects of clear aligners on speech articulation. The most used brand of aligners worldwide is Invisalign. 6 , 25 – 30 The height of the Invisalign aligner level is made at the gingival margin. 8 , 11 As in-office aligners have increased lately, there is no standard gingival margin level height at which in-office aligners are made. 7 , 9 Thakkar et al. , 9 published a workflow suggesting aligner trimming 2mm above, at, or with a gingival margin scallop. Laboratory studies show the greater the edge height of the aligner, the greater retentivity. 13 Higher aligner height may cause lip/cheek discomfort, but no standard exists. We assessed patient satisfaction with two types of clear aligners: those trimmed at the gingival margin level and those extending approximately 2 mm above the gingival margin. We mention that the aligners had approximately a 2 mm height due to the fact que those in-office aligners were cut by the authors themselves, trying their best to achieve the 2mm distance, which may not have been possible exactly in the hole contour of the aligners. There was no difference in the responses to the questionnaire regarding the nine evaluated items when using the 2 types of in-office clear aligners (Table I). The first evaluated item was the adaptation; all the patients reported an easy adaptation to both. Studies show that CAT is highly accepted, and their adaptation is faster. 29 , 30 These results show similar results with studies that show that CAT is better accepted, 28 mainly when compared to other orthodontic treatment modalities. 27 , 31 , 32 Patients gave high scores for all evaluated items to aligners with both marginal levels. It can be presumed that patients had a good adaptation, and the acceptance was similar for both gingival margin level heights. Also, patients reported no difficulties speaking with both aligners (Table I). Our results are different from most found in the literature. Recent studies showed that speech difficulties appear high with clear aligners. 33 , 34 Pogal-Sussman-Gandia et al. 26 stated that these difficulties occur mainly in articulating some consonants. This difference was because we did not assess specific words to quantify difficulty in pronouncing them while wearing the aligners. However, patients adapt quickly, and speech returns to normal within a few months. 33 , 34 The 0mm gingival margin level was chosen for 69.57% of the patients (Table II). The reasons were mainly comfort, adaptation, and aesthetics (Fig. 4 A). Those who opted for the 2 mm aligner mentioned good fit, adaptation, and retention as the main reasons (Fig. 4 B). Despite this, 43% of patients who chose the 2 mm aligner mentioned retention as a factor. This data agrees with an in vitro study conducted by Cowley et al. , 13 which showed that aligners with a 2mm gingival margin have greater retention than those trim at the gingival level. However, we must Interpret data cautiously, as the study had limitations in material and aligner thickness not used according to two systematic reviews. 6 , 8 Among patients who opted for the edge at the gingival level, comfort was the most mentioned reason (69%), followed by good adaptation (56%) (Fig. 4 A). As discussed, aligner comfort improves patients' quality of life compared to fixed appliance treatment . 35 The present study did not show a significant difference in the Gingival Index Bleed (G.I.) between the aligner's gingival levels (Table III). Both aligner heights maintain good periodontal health. It is essential to point out that most studies compared aligners to fixed appliances, and CAT patients showed better periodontal health. 25 , 36 , 37 The patients improved this index during treatment (Table III). This result agrees with some authors. 25 , 37 , 38 It can be speculated that this improvement in the G.I. is due to the constant motivation for oral hygiene that the patient received during treatment. Studies show patients improve oral hygiene habits and awareness during early CAT. 38 , 39 The lack of long-term observations limited our study. Thus, conducting further research with a larger sample size and an extended observation period would be interesting. Clinical implications Results show no significant difference between the gingival margin and alternative aligner design, despite the patient preference for gingival margin design. Therefore, the aligner design can be customized based on individual anatomy and tooth movement needs, and the gingival margin can also be adjusted based on tooth size and planned movement. 40 CONCLUSION There was no difference in the adaptation, comfort, and retention between the aligners with 0 and 2mm gingival marginal levels Aligners with 0mm marginal level were chosen by 69.57% of patients, who mentioned that comfort and good fit were the main reasons for choosing them. There was no difference in G.I. between the 0mm and 1mm gingival marginal levels. Declarations Funding No funding was required for this study. Author Contribution Eduardo Terumi Blatt Ohira: Study concept and design, data acquisition, analysis of data, manuscript draft and review.Tiago Fialho: data acquisition, manuscript draft and reviewSamira Salmeron: manuscript draft, analysis of data, Scientific review and Manuscript review.Karina Maria Salvatore Freitas: Study concept and design, analysis of data, statistical analysis, manuscript draft and review.Celia Regina Maio Pinzan-Vercelino: Scientific review. Manuscript review.Fabrício Pinelli Valarelli: Scientific review. Manuscript review.Renata Cristina Gobbi de Oliveira: Scientific review. Manuscript review.Ricardo César Gobbi de Oliveira: Scientific review. Manuscript review.Paula Cotrin: Study concept and design, analysis of data, manuscript draft and review. Scientific review. Manuscript review. Study supervision Data Availability The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request. Data are located in controlled access data storage at Ingá University Center. References Alansari, R. A., Faydhi, D. A., Ashour, B,S., Alsaggaf, D.H., Shuman, M. T & Ghoneim, S.H. Adult Perceptions of Different Orthodontic Appliances. Patient Prefer Adherence . 13 , 2119-2128 (2019). Favero, R., Libralato, L., Balestro, F., Volpato, A. & Favero, L. Edge level of aligners and periodontal health: a clinical perspective study in young patients. Dental Press J Orthod. 28 , e2321124 (2023). Krey, K-F.H, Hartmann, M., Schicker, P., Corteville, F. & Eigenwillig, P. Complete digital in office workflow for aligner treatment with a fused filament fabrication (FFF) 3D printer: Technical considerations and report of cases. Journal of Aligner Orthodontics . 3 , 195-204 (2019). Can, E., Panayi, N., Polychronis, G., Papageorgiou, S.N., Zinelis, S. & Eliades, G. In-house 3D-printed aligners: effect of in vivo ageing on mechanical properties. Eur J Orthod . 44 , 51-55 (2022). Tozlu, M. & Ozdemir, F. In-house Aligners: Why We Should Fabricate Aligners in Our Clinics? Turk J Orthod . 34 , 199-201 (2021). Bichu, Y.M., Alwafi, A., Liu, X., Andrews, J., Ludwig, B. & Bichu, A.Y. Advances in orthodontic clear aligner materials. Bioact Mater . 22 , 384-403 (2023). Khosravi, R., Gidarakou, I. & Salazar, T. Essential factors in developing an efficient in-office aligner system. Seminars in Orthodontics . 28 , 45-52 (2022). Putrino, A., Barbato, E. & Galluccio, G. Clear Aligners: Between Evolution and Efficiency-A Scoping Review . Int J Environ Res Public Health . 18 (2021). Thakkar, D., Benattia, A., Bichu, Y.M., Zou, B., Aristizabal, J.F. & Fadia, D. Seamless workflows for in-house aligner fabrication. Seminars in Orthodontics . 29 , 17-24 (2023). Gao, L. & Wichelhaus, A. Forces and moments delivered by the PET-G aligner to a maxillary central incisor for palatal tipping and intrusion. Angle Orthod . 87 , 534-541 (2017). Align Technology, I. A diferença do Invisalign. invisalign.com.br: Align Technology, Inc ; 2023. Takara, Y., Haga, S., Kimura, H. & Maki, K. Mechanical analysis of factors affecting clear aligner removability. Dent Mater J . 41 , 534-544 (2022). Cowley, D.P., Mah, J. & O'Toole, B. The effect of gingival-margin design on the retention of thermoformed aligners. J Clin Orthod . 46 , 697-702, quiz 705 (2012). Haouili, N., Kravitz, N.D., Vaid, N.R., Ferguson, D.J. & Makki, L. Has Invisalign improved? A prospective follow-up study on the efficacy of tooth movement with Invisalign. Am J Orthod Dentofacial Orthop . 158 , 420-425 (2020). Kravitz, N.D., Kusnoto, B., BeGole, E., Obrez, A. & Agran, B. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign. Am J Orthod Dentofacial Orthop . 135 , 27-35 (2009). Mota Junior, S.L., Hartmann, G.C., Vitral, R.F. & Tanaka, O.M. Efficacy of incisor movement with clear aligners: What about interval changes for aligners? Am J Orthod Dentofacial Orthop . 160 , 4892021 (2021). D'Anto, V., Bucci, R., De Simone, V., Huanca Ghislanzoni, L., Michelotti, A. & Rongo, R. Evaluation of Tooth Movement Accuracy with Aligners: A Prospective Study. Materials (Basel) . 15 (2022). Jaber, S.T., Hajeer, M.Y. & Burhan, A.S. The Effectiveness of In-house Clear Aligners and Traditional Fixed Appliances in Achieving Good Occlusion in Complex Orthodontic Cases: A Randomized Control Clinical Trial. Cureus . 14 , e30147 (2022). Chagas, A.S., Freitas, K.M.S., Cançado, R.H., Valarelli, F.P., Canuto, L.F.G. & Oliveira, R.C.G. Level of satisfaction in the use of the wraparound Hawley and thermoplastic maxillary retainers. Angle Orthod . 90 , 63-68 (2020). Elshazly, T.M., Bourauel, C., Aldesoki, M., Salvatori, D., Alhotan, A. & Keilig, L. Effect of attachment configuration and trim line design on the force system of orthodontic aligners: A finite element study on the upper central incisor. Orthod Craniofac Res . 27 , Suppl 2(Suppl 2), 131-140 (2024). Thai, J.K., Araujo, E., McCray, J., Schneider, P.P. & Kim, K.B. Esthetic perception of clear aligner therapy attachments using eye-tracking technology. Am J Orthod Dentofacial Orthop . 158 , 400-409 (2020) Linjawi, A.I. & Abushal, A.M. Adaptational changes in clear aligner fit with time. Angle Orthod . 92 , 220-225 (2022). Loe, H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 38 , Suppl:610-616 (1967). Fialho, T., de Freitas, K.M.S., Ohira, E.T.B., de Souza, J.E.P., de Oliveira, R.C.G, de Oliveira, R.C.G., Valarelli, F.P., Pinzan-Vercelino, C.R.M. & Cotrin, P. Comparison of the efficiency of initial dental alignment with Invisalign® aligners changed every 7 or 14 days in mature adults: Randomized clinical trial. Orthod Craniofac Res . 27 , 544-551 (2024). Levrini, L., Mangano, A., Montanari, P., Margherini, S., Caprioglio, A. & Abbate, G.M. Periodontal health status in patients treated with the Invisalign((R)) system and fixed orthodontic appliances: A 3 months clinical and microbiological evaluation. Eur J Dent . 9 , 404-410 (2015). Pogal-Sussman-Gandia, C.B., Tabbaa, S. & Al-Jewair, T. Effects of Invisalign (R) treatment on speech articulation. Int Orthod . 17 , 513-518 (2019). Antonio-Zancajo, L., Montero, J., Albaladejo, A., Oteo-Calatayud, M.D. & Alvarado-Lorenzo, A. Pain and Oral-Health-Related Quality of Life in Orthodontic Patients During Initial Therapy with Conventional, Low-Friction, and Lingual Brackets and Aligners (Invisalign): A Prospective Clinical Study. J Clin Med . 9 (2020). Flores-Mir, C., Brandelli, J. & Pacheco-Pereira, C. Patient satisfaction and quality of life status after 2 treatment modalities: Invisalign and conventional fixed appliances. Am J Orthod Dentofacial Orthop. 154 , 639-644 (2018). Nedwed, V. & Miethke, R.R. Motivation, acceptance and problems of invisalign patients. J Orofac Orthop . 66 , 162-173 (2005). Sharma, R., Drummond, R., Wiltshire, W., Schroth, R., Lekic, M. & Bertone M. Quality of life in an adolescent orthodontic population. Angle Orthod . 91 , 718-724 (2021). Alfawal, A.M.H., Burhan, A.S., Mahmoud, G., Ajaj, M.A., Nawaya, F.R. & Hanafi, I. The impact of non-extraction orthodontic treatment on oral health-related quality of life: clear aligners versus fixed appliances-a randomized controlled trial. Eur J Orthod . 44 , 595-602 (2022). Gao, M., Yan, X., Zhao, R., Shan, Y., Chen, Y. & Jian, F. Comparison of pain perception, anxiety, and impacts on oral health-related quality of life between patients receiving clear aligners and fixed appliances during the initial stage of orthodontic treatment. Eur J Orthod . 43 , 353-359 (2021). Ali Baeshen, H., El-Bialy, T., Alshehri, A., Awadh, W., Thomas, J. & Dhillon, H. The effect of clear aligners on speech: a systematic review. Eur J Orthod . 45 , 11-19 (2023). Fraundorf, E.C., Araujo, E., Ueno, H., Schneider, P.P. & Kim, K.B. Speech performance in adult patients undergoing Invisalign treatment. Angle Orthod . 92 , 80-86 (2022). Lin, F., Yao, L., Bhikoo, C. & Guo, J. Impact of fixed orthodontic appliance or clear-aligner on daily performance, in adult patients with moderate need for treatment. Patient Prefer Adherence. 10 , 1639-1645 (2016). Azaripour, A., Weusmann, J., Mahmoodi, B., Peppas, D., Gerhold-Ay, A. & Van Noorden, C.J. Braces versus Invisalign(R): gingival parameters and patients' satisfaction during treatment: a cross-sectional study. BMC Oral Health . 15 , 69 (2015). Rossini, G., Parrini, S., Castroflorio, T., Deregibus, A. & Debernardi, C.L. Periodontal health during clear aligners treatment: a systematic review. Eur J Orthod. 37 ,539-543 (2015). Zhao, R., Huang, R., Long, H., Li, Y., Gao, M. & Lai, W. The dynamics of the oral microbiome and oral health among patients receiving clear aligner orthodontic treatment. Oral Dis . 26 , 473-483 (2020). Saccomanno, S., Saran, S., Laganà, D., Mastrapasqua, R.F. & Grippaudo, C. Motivation, Perception, and Behavior of the Adult Orthodontic Patient: A Survey Analysis. Biomed Res Int. 2022 , 2754051 (2022). Lyu, X., Cao, X., Yan, J., Zeng, R. & Tan, J. Biomechanical effects of clear aligners with different thicknesses and gingival-margin morphology for appliance design optimization. Am J Orthod Dentofacial Orthop . 164 , 239-252 (2023). Tables Tables 1 to 3 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table1.docx Table I – Comparison of responses to the questionnaire evaluating the items for satisfaction use of clear aligners (Wilcoxon Test). Table2.docx Table II – Patients' preference between the two different gingival margin levels. Table3.docx Table III – Comparison in the gingival index (G.I.) with two different gingival margins of clear aligners - 0mm and 1mm (dependent t-test). Cite Share Download PDF Status: Posted Version 1 posted 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. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-6784996","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":467454680,"identity":"23b6d767-aa06-4253-a30c-0f8b6dfe9df7","order_by":0,"name":"Eduardo Terumi Blatt Ohira","email":"","orcid":"","institution":"Ingá University Center","correspondingAuthor":false,"prefix":"","firstName":"Eduardo","middleName":"Terumi Blatt","lastName":"Ohira","suffix":""},{"id":467454684,"identity":"a55cedec-f100-49ec-a8d9-adf20052dfa7","order_by":1,"name":"Tiago Fialho","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA20lEQVRIiWNgGAWjYDACZsYHBxgKDjDwS4C5EjIEdfAwMxscYAAiyRkMjA1ALTyEtTAwGzCAtBjcAGthIKzFnp2Z8cAPgztyxrebjz+6UWPBw8B++OgGAg5jONhj8MzY7M6xxOacY0CH8aSl3cCvhf/AAR6Dw4nbbuQYNuewAbVI8JgR0AK05Q9Qy+YZIC3/iNRyGGTLBgmgltw2YrQcBmqRMThsLHEjLXF2bp8EDxshv7D3H2b++KbisBz/jOQDn3O+1cnxsx8+hlcLJmAjTfkoGAWjYBSMAmwAAIivRdNv1EsUAAAAAElFTkSuQmCC","orcid":"","institution":"Ingá University Center","correspondingAuthor":true,"prefix":"","firstName":"Tiago","middleName":"","lastName":"Fialho","suffix":""},{"id":467454685,"identity":"dac70c80-0187-45b5-a153-04d567252f56","order_by":2,"name":"Samira Salmeron","email":"","orcid":"","institution":"Ingá University Center","correspondingAuthor":false,"prefix":"","firstName":"Samira","middleName":"","lastName":"Salmeron","suffix":""},{"id":467454686,"identity":"afc1d77a-d653-45e5-a7e8-9ec63b7ac1e6","order_by":3,"name":"Karina Maria Salvatore de Freitas","email":"","orcid":"","institution":"Ingá University Center","correspondingAuthor":false,"prefix":"","firstName":"Karina","middleName":"Maria Salvatore","lastName":"de Freitas","suffix":""},{"id":467454687,"identity":"0297c18d-6fac-4f2c-9b8f-22eec9a10db6","order_by":4,"name":"Celia Regina Maio Pinzan-Vercelino","email":"","orcid":"","institution":"Ingá University Center","correspondingAuthor":false,"prefix":"","firstName":"Celia","middleName":"Regina Maio","lastName":"Pinzan-Vercelino","suffix":""},{"id":467454688,"identity":"5acf25aa-adb5-463f-9aa8-ade7e7bf0c60","order_by":5,"name":"Fabrício Pinelli Valarelli","email":"","orcid":"","institution":"Ingá University Center","correspondingAuthor":false,"prefix":"","firstName":"Fabrício","middleName":"Pinelli","lastName":"Valarelli","suffix":""},{"id":467454689,"identity":"7ca0deb3-4dd4-4c1e-bda8-5715cbdf621c","order_by":6,"name":"Renata Cristina Gobbi de Oliveira","email":"","orcid":"","institution":"Ingá University Center","correspondingAuthor":false,"prefix":"","firstName":"Renata","middleName":"Cristina Gobbi","lastName":"de Oliveira","suffix":""},{"id":467454690,"identity":"35d053c1-d64a-47fc-81a2-181e5a3d5ae9","order_by":7,"name":"Ricardo César Gobbi de Oliveira","email":"","orcid":"","institution":"Ingá University Center","correspondingAuthor":false,"prefix":"","firstName":"Ricardo","middleName":"César Gobbi","lastName":"de Oliveira","suffix":""},{"id":467454691,"identity":"0fa6de2e-42bc-4166-98f4-35f9dc3c9d21","order_by":8,"name":"Paula Cotrin","email":"","orcid":"","institution":"Ingá University Center","correspondingAuthor":false,"prefix":"","firstName":"Paula","middleName":"","lastName":"Cotrin","suffix":""}],"badges":[],"createdAt":"2025-05-30 13:08:15","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6784996/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6784996/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":84306280,"identity":"084a52cf-2b59-43cf-9f17-5ded4fbf2134","added_by":"auto","created_at":"2025-06-10 11:24:43","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":2186694,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003e(A: \u003c/strong\u003eClear aligner cut at the gingival margin – 0mm; \u003cstrong\u003eB: \u003c/strong\u003eClear aligner cut 1mm above gingival marginal – 1mm)\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-6784996/v1/9d8a38971b43984b9f0580bc.png"},{"id":84306282,"identity":"1b965329-f17d-47d9-bf11-f5a16e55a5d5","added_by":"auto","created_at":"2025-06-10 11:24:43","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":1028977,"visible":true,"origin":"","legend":"\u003cp\u003eQuestionnaire workflow\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-6784996/v1/3fcff613b47e90c4f8dd1619.png"},{"id":84306346,"identity":"e97846f8-9e28-469e-84d0-84c017eecc83","added_by":"auto","created_at":"2025-06-10 11:24:46","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":438194,"visible":true,"origin":"","legend":"\u003cp\u003ePatient flow\u003c/p\u003e","description":"","filename":"Figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-6784996/v1/de2d040b796660a7bab208ec.png"},{"id":84306374,"identity":"d78e810b-719b-4a9d-93cd-c29ead8e6a6d","added_by":"auto","created_at":"2025-06-10 11:24:46","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":394466,"visible":true,"origin":"","legend":"\u003cp\u003e(\u003cstrong\u003eA: \u003c/strong\u003eReasons for choosing the aligner with 0mm gingival margin level; \u003cstrong\u003eB: \u003c/strong\u003eReasons for choosing the aligner with 1mm gingival margin level).\u003c/p\u003e","description":"","filename":"Figure4.png","url":"https://assets-eu.researchsquare.com/files/rs-6784996/v1/bbf1ce7bdef4a64e3a05c02f.png"},{"id":97135462,"identity":"d10e6129-edc2-46c4-a7e1-8e4cb4b87442","added_by":"auto","created_at":"2025-12-01 09:47:36","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":4647326,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6784996/v1/71569f71-e0e2-43f9-9ea7-a4748cf24c09.pdf"},{"id":84306309,"identity":"c1298882-894b-4862-afff-80df46f9347b","added_by":"auto","created_at":"2025-06-10 11:24:44","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":16620,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTable I \u003c/strong\u003e– Comparison of responses to the questionnaire evaluating the items for satisfaction use of clear aligners (Wilcoxon Test).\u003c/p\u003e","description":"","filename":"Table1.docx","url":"https://assets-eu.researchsquare.com/files/rs-6784996/v1/4522e92ccd07c10db58073b9.docx"},{"id":84306270,"identity":"3a0db8fe-368c-4d57-8908-717143c937e0","added_by":"auto","created_at":"2025-06-10 11:24:42","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":15968,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTable II \u003c/strong\u003e– Patients' preference between the two different gingival margin levels.\u003c/p\u003e","description":"","filename":"Table2.docx","url":"https://assets-eu.researchsquare.com/files/rs-6784996/v1/a8f3930778decad88d766420.docx"},{"id":84306243,"identity":"532da89f-d5e6-4cf1-afe0-d3630e34d916","added_by":"auto","created_at":"2025-06-10 11:24:41","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":14796,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTable III \u003c/strong\u003e– Comparison in the gingival index (G.I.) with two different gingival margins of clear aligners - 0mm and 1mm (dependent t-test).\u003c/p\u003e","description":"","filename":"Table3.docx","url":"https://assets-eu.researchsquare.com/files/rs-6784996/v1/5786b4d0d3a799535a6c45e9.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Comparison of patient adaptation with in-office aligners with two different levels of the gingival margin","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eClear aligner therapy (CAT) has become a popular and well-accepted alternative for orthodontic treatments.\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e,\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e With the increasing popularity of the digital workflow, the possibility of producing aligners in private dental offices is a reality for many orthodontists.\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e Invisalign's clear aligners have led to more companies offering similar services to orthodontists. But these services can be more expensive and have varying delivery times and fees.\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e In-office aligners are faster and cheaper and allow orthodontists to customize the orthodontic treatment at every stage.\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e There is no standard for manufacturing clear aligners, as each company follows its recommendation regarding the material, thickness, and gingival margin of the aligners.\u003csup\u003e\u003cspan additionalcitationids=\"CR7 CR8\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e Clear aligners can feature a scalloped or straight cut margin at the gingival level, ranging from 0 to 2mm above it.\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe Invisalign system is the most used commercial clear aligner system worldwide.\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e More than 90% of research is carried out with Invisalign.\u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e Currently, the company cut their aligners with a scalloped gingival margin.\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e,\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e The ideal gingival margin level for in-office aligners is unclear. In vitro studies favor straight margins over those trimmed at 2mm or less.\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e,\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e Despite the studies that evaluated CAT,\u003csup\u003e\u003cspan additionalcitationids=\"CR15\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e almost none specify the height of the marginal level at which this aligner was manufactured.\u003csup\u003e\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e,\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e. Studies on the size and design of the gingival margin of the aligners are primarily \u003cem\u003ein vitro\u003c/em\u003e,\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e,\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e and the patient's perception is underestimated. Therefore, evaluating the perception of comfort, retention, and gingival health becomes essential for the orthodontist to decide how to trim the in-office aligner. In this context, This study aims to compare patient adaptation and periodontal health outcomes between in-office clear aligners with different gingival margin cuts: at the gingival level and extending 2mm above the gingival margin.\u003c/p\u003e"},{"header":"MATERIAL AND METHODS","content":"\u003cp\u003e This prospective study was approved by the Ethics Research Committee of Ing\u0026aacute; University Center (under # 51507321.9.0000.5220; Annex II). All methods were performed in accordance with the relevant guidelines and regulations. Written informed consent was obtained before the patients were randomized into the treatment groups.\u003c/p\u003e \u003cp\u003eThe sample size calculation was based on an alpha significance level of 5% (0.05) and a beta of 20% (0.20) to reach a test power of 80% and detect a minimum difference of 2 points with a standard deviation 2.19 for a numerical scale indicating comfort.\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e The minimum sample required was 20 patients.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eParticipants, eligibility criteria, and settings\u003c/h2\u003e \u003cp\u003eThis prospective study was conducted from June/21 to June/22, and the sample selection was carried out in a private clinic in ________________. Inclusion criteria were patients of both sexes aged 18 to 45 years; all erupted permanent teeth up to first molars, Class I malocclusion, and mild to moderate anterior crowding. Patients who fit the inclusion criteria were invited to participate, and all patients filled out an informed consent form.\u003c/p\u003e \u003cp\u003eAll patients were treated with in-office clear aligners produced in partnership with \u003cem\u003eContraste Radiology\u003c/em\u003e (Contraste, Blumenau, SC, Brazil). Before treatment, all orthodontic digital planning with the \u003cem\u003eOrthoAnalyzer\u003c/em\u003e software (3Shape, Copenhagen, Denmark) was performed by the same professional (ETBO). The Cases received prescribed attachments and interproximal reduction as prescribed, without any accessory mechanics.\u003c/p\u003e \u003cp\u003eEven though attachments may directly influence retention\u003csup\u003e\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u003c/sup\u003e, aesthetics\u003csup\u003e\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e, and adaptability\u003csup\u003e\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e of the aligners, specially in situations where the gingival-level trimming is lower, all participants used the same attachments in both samples of aligners for this study. Attachments were placed accordingly to their needs and requirements for their individual treatment, so it would not interfere as a bias for this study. All patients received instructions on a standardized oral hygiene protocol.\u003c/p\u003e \u003cp\u003eThe final sample comprised 23 patients (17 women and 6 men) with a mean age of 28.74\u0026thinsp;\u0026plusmn;\u0026thinsp;6.8. The mean initial maxillary and mandibular irregularity indexes were 3.95mm (1.5mm) and 3.66mm (2.16mm). The mean number of initial attachments was 1.91 (3.38mm). All patients used the 2 pairs of aligners with a straight cut at the gingival level (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eA) and 2 pairs with a straight cut aproximatelly 2mm above the gingival level (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eB). Half of the sample started using the 0mm aligners, and the other half used the 2mm. Patients were advised to wear their aligners 20 hours a day and to change each set every 15 days. The total treatment time for each sequence of aligners was 1 month. A one-month washout period was implemented between the use of aligners with different gingival margin levels. At the end of 1 month, the patients received their subsequent aligner with a different marginal cut.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eAll aligners were made with 0.8mm PET-G (Forestadent Track-A, Germany), using a pressure thermoforming (Drufosmart D3200, Drevem, Germany), and the cutting and polish were performed manually with disks and cutters (DhPro, Kit Paschotto \u0026amp; Ohira, Brazil) by the same professional (ETBO).\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eQuestionnaire\u003c/h3\u003e\n\u003cp\u003eImmediately after using each pair of aligners, the patients answered on Google forms a closed questionnaire to assess their perception regarding using the 2 types of aligners.\u003c/p\u003e \u003cp\u003eIn the questionnaire, based on a previous study that evaluated comfort,\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e nine items were evaluated (adaptability, speech, swallowing, soft tissue comfort, overall satisfaction, cleaning, aesthetics, durability, fitting, and retention. The patient scored 0\u0026ndash;10, with 0 being poor and 10 excellent.\u003c/p\u003e \u003cp\u003eAfter completing the two research phases, the patients answered a final comparative questionnaire to choose the aligners with their preferred gingival margin edges. They explained the reasons for the last open question. The data were uploaded to Excel (Microsoft Office 365, Redmond, USA).\u003c/p\u003e \u003cp\u003eThe questionnaire workflow can be seen in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe Gingival Index Bleed (G.I.) was evaluated at pretreatment and at the end of each aligner sequence by the same operator (ETBO) to assess periodontal health. The G.I. was evaluated according to Loe's methodology.\u003csup\u003e\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eThe normality of the data was evaluated using the Shapiro-Wilk test. The comparison between the grades received for each item from the questionnaire was performed using the Wilcoxon test.\u003c/p\u003e \u003cp\u003eThe difference between the G.I. for each gingival margin was performed with dependent t-test.\u003c/p\u003e \u003cp\u003eDescriptive statistics were used to determine the preference between aligners, and descriptive statistics and percentage comparison were used to assess the reasons that led patients to choose the gingival margin.\u003c/p\u003e \u003cp\u003eAll statistical analyses were performed using the Statistica software for Windows (Version 10.0; StatSoft, Tulsa, Okla) and were considered significant when p\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cp\u003eDuring recruitment, 32 patients were assessed for eligibility. However, 6 were excluded for not meeting the inclusion criteria. Twenty-six patients participated in the research. Three patients dropped out of treatment during follow-up and were removed from the study (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThere was no statistically significant difference regarding the nine evaluated items between the 0mm and 2mm aligners (Table I). The 0mm gingival margin was chosen for 69.57% of the patients (Table II). The most mentioned reasons were: comfort, adaptation, and aesthetics (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003eA). Those who opted for the 2mm aligner said good fit, adaptation, and retention as the main reasons (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003eB).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThere was no significant difference in G.I. after using the 0mm or 2mm aligners (Table III).\u003c/p\u003e\n\u003ch3\u003eHarms\u003c/h3\u003e\n\u003cp\u003eNo harm was observed in patients (e.g., fractures, injuries); patients were advised to stop using aligners if allergies occurred. No allergic reactions occurred, and Aligners were discarded after treatment.\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eAll patients wore each type of aligner for one month. After using two pairs of aligners for one month, a one-month washout period was implemented before using the next set of aligners with a different gingival height. This was necessary to ensure accurate evaluation of the same patient without influence from the previous aligner with a different gingival cut height. The progressive replacement regimen was recommended every 15 days and agrees with the current orthodontic literature.\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e,\u003cspan additionalcitationids=\"CR25\" citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e According to Chagas \u003cem\u003eet al.\u003c/em\u003e\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e one month of use is enough for patients to assess their satisfaction and adaptation to the device. Half of the sample started using 0mm aligners and the other half 2 mm to avoid bias caused by the first aligner's experience influencing the second's perception. All patients used both types of aligners. In addition, little's irregularity index at the beginning of treatment was small. Therefore, the degree of crowding, associated with a low rate of movement per aligner, may not have interfered with the comparison. It is essential to highlight that the objective of our study was not to evaluate the correction of the malocclusion but only the patient's perception during the use of the aligners.\u003c/p\u003e \u003cp\u003eTo assess the patient's perception of the characteristics of each type of aligner, we used a questionnaire based on the study of Chagas \u003cem\u003eet al.\u003c/em\u003e\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. It may be considered a study limitation because the questionnaire was not validated. However, the questions used allowed a more accurate assessment of patients concerning specific aspects, such as perception of fit and retention of the aligner. Pogal-Sussman-Gandia \u003cem\u003eet al.\u003c/em\u003e\u003csup\u003e\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e also used a non-validated questionnaire in their study about the effects of clear aligners on speech articulation.\u003c/p\u003e \u003cp\u003eThe most used brand of aligners worldwide is Invisalign.\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e,\u003cspan additionalcitationids=\"CR26 CR27 CR28 CR29\" citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e\u003c/sup\u003e The height of the Invisalign aligner level is made at the gingival margin.\u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e,\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e As in-office aligners have increased lately, there is no standard gingival margin level height at which in-office aligners are made.\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e,\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e Thakkar \u003cem\u003eet al.\u003c/em\u003e,\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e published a workflow suggesting aligner trimming 2mm above, at, or with a gingival margin scallop. Laboratory studies show the greater the edge height of the aligner, the greater retentivity.\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e Higher aligner height may cause lip/cheek discomfort, but no standard exists. We assessed patient satisfaction with two types of clear aligners: those trimmed at the gingival margin level and those extending approximately 2 mm above the gingival margin. We mention that the aligners had approximately a 2 mm height due to the fact que those in-office aligners were cut by the authors themselves, trying their best to achieve the 2mm distance, which may not have been possible exactly in the hole contour of the aligners.\u003c/p\u003e \u003cp\u003eThere was no difference in the responses to the questionnaire regarding the nine evaluated items when using the 2 types of in-office clear aligners (Table I). The first evaluated item was the adaptation; all the patients reported an easy adaptation to both. Studies show that CAT is highly accepted, and their adaptation is faster.\u003csup\u003e\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e,\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e\u003c/sup\u003e These results show similar results with studies that show that CAT is better accepted,\u003csup\u003e\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u003c/sup\u003e mainly when compared to other orthodontic treatment modalities.\u003csup\u003e\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e,\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e,\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003ePatients gave high scores for all evaluated items to aligners with both marginal levels. It can be presumed that patients had a good adaptation, and the acceptance was similar for both gingival margin level heights. Also, patients reported no difficulties speaking with both aligners (Table I). Our results are different from most found in the literature. Recent studies showed that speech difficulties appear high with clear aligners.\u003csup\u003e\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e,\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e\u003c/sup\u003e Pogal-Sussman-Gandia \u003cem\u003eet al.\u003c/em\u003e\u003csup\u003e\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e stated that these difficulties occur mainly in articulating some consonants. This difference was because we did not assess specific words to quantify difficulty in pronouncing them while wearing the aligners. However, patients adapt quickly, and speech returns to normal within a few months.\u003csup\u003e\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e,\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe 0mm gingival margin level was chosen for 69.57% of the patients (Table II). The reasons were mainly comfort, adaptation, and aesthetics (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003eA). Those who opted for the 2 mm aligner mentioned good fit, adaptation, and retention as the main reasons (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003eB). Despite this, 43% of patients who chose the 2 mm aligner mentioned retention as a factor. This data agrees with an in vitro study conducted by Cowley \u003cem\u003eet al.\u003c/em\u003e,\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e which showed that aligners with a 2mm gingival margin have greater retention than those trim at the gingival level. However, we must Interpret data cautiously, as the study had limitations in material and aligner thickness not used according to two systematic reviews.\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e,\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eAmong patients who opted for the edge at the gingival level, comfort was the most mentioned reason (69%), followed by good adaptation (56%) (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003eA). As discussed, aligner comfort improves patients' quality of life compared to fixed appliance treatment .\u003csup\u003e\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe present study did not show a significant difference in the Gingival Index Bleed (G.I.) between the aligner's gingival levels (Table III). Both aligner heights maintain good periodontal health. It is essential to point out that most studies compared aligners to fixed appliances, and CAT patients showed better periodontal health.\u003csup\u003e\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e,\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e,\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e\u003c/sup\u003e The patients improved this index during treatment (Table III). This result agrees with some authors.\u003csup\u003e\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e,\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e,\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e\u003c/sup\u003e It can be speculated that this improvement in the G.I. is due to the constant motivation for oral hygiene that the patient received during treatment. Studies show patients improve oral hygiene habits and awareness during early CAT.\u003csup\u003e\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e,\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e\u003c/sup\u003e The lack of long-term observations limited our study. Thus, conducting further research with a larger sample size and an extended observation period would be interesting.\u003c/p\u003e\n\u003ch3\u003eClinical implications\u003c/h3\u003e\n\u003cp\u003eResults show no significant difference between the gingival margin and alternative aligner design, despite the patient preference for gingival margin design. Therefore, the aligner design can be customized based on individual anatomy and tooth movement needs, and the gingival margin can also be adjusted based on tooth size and planned movement.\u003csup\u003e\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cul\u003e\n \u003cli\u003eThere was no difference in the adaptation, comfort, and retention between the aligners with 0 and 2mm gingival marginal levels\u003c/li\u003e\n \u003cli\u003eAligners with 0mm marginal level were chosen by 69.57% of patients, who mentioned that comfort and good fit were the main reasons for choosing them.\u003c/li\u003e\n \u003cli\u003eThere was no difference in G.I. between the 0mm and 1mm gingival marginal levels.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Declarations","content":"\u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eNo funding was required for this study.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eEduardo Terumi Blatt Ohira: Study concept and design, data acquisition, analysis of data, manuscript draft and review.Tiago Fialho: data acquisition, manuscript draft and reviewSamira Salmeron: manuscript draft, analysis of data, Scientific review and Manuscript review.Karina Maria Salvatore Freitas: Study concept and design, analysis of data, statistical analysis, manuscript draft and review.Celia Regina Maio Pinzan-Vercelino: Scientific review. Manuscript review.Fabr\u0026iacute;cio Pinelli Valarelli: Scientific review. Manuscript review.Renata Cristina Gobbi de Oliveira: Scientific review. Manuscript review.Ricardo C\u0026eacute;sar Gobbi de Oliveira: Scientific review. Manuscript review.Paula Cotrin: Study concept and design, analysis of data, manuscript draft and review. Scientific review. Manuscript review. Study supervision\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request. Data are located in controlled access data storage at Ing\u0026aacute; University Center.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eAlansari, R. A., Faydhi, D. A., Ashour, B,S., Alsaggaf, D.H., Shuman, M. T \u0026amp; Ghoneim, S.H. Adult Perceptions of Different Orthodontic Appliances. \u003cem\u003ePatient Prefer Adherence\u003c/em\u003e. \u003cstrong\u003e13\u003c/strong\u003e, 2119-2128 (2019).\u003c/li\u003e\n\u003cli\u003eFavero, R., Libralato, L., Balestro, F., Volpato, A. \u0026amp; Favero, L. Edge level of aligners and periodontal health: a clinical perspective study in young patients. \u003cem\u003eDental Press J Orthod.\u003c/em\u003e \u003cstrong\u003e28\u003c/strong\u003e, e2321124 (2023).\u003c/li\u003e\n\u003cli\u003eKrey, K-F.H, Hartmann, M., Schicker, P., Corteville, F. \u0026amp; Eigenwillig, P. Complete digital in office workflow for aligner treatment with a fused filament fabrication (FFF) 3D printer: Technical considerations and report of cases. \u003cem\u003eJournal of Aligner Orthodontics\u003c/em\u003e. \u003cstrong\u003e3\u003c/strong\u003e, 195-204 (2019).\u003c/li\u003e\n\u003cli\u003eCan, E., Panayi, N., Polychronis, G., Papageorgiou, S.N., Zinelis, S. \u0026amp; Eliades, G. In-house 3D-printed aligners: effect of in vivo ageing on mechanical properties. \u003cem\u003eEur J Orthod\u003c/em\u003e. \u003cstrong\u003e44\u003c/strong\u003e, 51-55 (2022).\u003c/li\u003e\n\u003cli\u003eTozlu, M. \u0026amp; Ozdemir, F. In-house Aligners: Why We Should Fabricate Aligners in Our Clinics? \u003cem\u003eTurk J Orthod\u003c/em\u003e. \u003cstrong\u003e34\u003c/strong\u003e, 199-201 (2021).\u003c/li\u003e\n\u003cli\u003eBichu, Y.M., Alwafi, A., Liu, X., Andrews, J., Ludwig, B. \u0026amp; Bichu, A.Y. Advances in orthodontic clear aligner materials. \u003cem\u003eBioact Mater\u003c/em\u003e. \u003cstrong\u003e22\u003c/strong\u003e, 384-403 (2023).\u003c/li\u003e\n\u003cli\u003eKhosravi, R., Gidarakou, I. \u0026amp; Salazar, T. Essential factors in developing an efficient in-office aligner system. \u003cem\u003eSeminars in Orthodontics\u003c/em\u003e. \u003cstrong\u003e28\u003c/strong\u003e, 45-52 (2022).\u003c/li\u003e\n\u003cli\u003ePutrino, A., Barbato, E. \u0026amp; Galluccio, G. Clear Aligners: Between Evolution and Efficiency-A Scoping Review\u003cem\u003e. Int J Environ Res Public Health\u003c/em\u003e. \u003cstrong\u003e18\u003c/strong\u003e (2021).\u003c/li\u003e\n\u003cli\u003eThakkar, D., Benattia, A., Bichu, Y.M., Zou, B., Aristizabal, J.F. \u0026amp; Fadia, D. Seamless workflows for in-house aligner fabrication. \u003cem\u003eSeminars in Orthodontics\u003c/em\u003e. \u003cstrong\u003e29\u003c/strong\u003e, 17-24 (2023).\u003c/li\u003e\n\u003cli\u003eGao, L. \u0026amp; Wichelhaus, A. Forces and moments delivered by the PET-G aligner to a maxillary central incisor for palatal tipping and intrusion. \u003cem\u003eAngle Orthod\u003c/em\u003e. \u003cstrong\u003e87\u003c/strong\u003e, 534-541 (2017).\u003c/li\u003e\n\u003cli\u003eAlign Technology, I. A diferen\u0026ccedil;a do Invisalign. invisalign.com.br: \u003cem\u003eAlign Technology, Inc\u003c/em\u003e; 2023.\u003c/li\u003e\n\u003cli\u003eTakara, Y., Haga, S., Kimura, H. \u0026amp; Maki, K. Mechanical analysis of factors affecting clear aligner removability. \u003cem\u003eDent Mater J\u003c/em\u003e. \u003cstrong\u003e41\u003c/strong\u003e, 534-544 (2022).\u003c/li\u003e\n\u003cli\u003eCowley, D.P., Mah, J. \u0026amp; O\u0026apos;Toole, B. The effect of gingival-margin design on the retention of thermoformed aligners. \u003cem\u003eJ Clin Orthod\u003c/em\u003e. \u003cstrong\u003e46\u003c/strong\u003e, 697-702, quiz 705 (2012).\u003c/li\u003e\n\u003cli\u003eHaouili, N., Kravitz, N.D., Vaid, N.R., Ferguson, D.J. \u0026amp; Makki, L. Has Invisalign improved? A prospective follow-up study on the efficacy of tooth movement with Invisalign. \u003cem\u003eAm J Orthod Dentofacial Orthop\u003c/em\u003e. \u003cstrong\u003e158\u003c/strong\u003e, 420-425 (2020).\u003c/li\u003e\n\u003cli\u003eKravitz, N.D., Kusnoto, B., BeGole, E., Obrez, A. \u0026amp; Agran, B. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign. \u003cem\u003eAm J Orthod Dentofacial Orthop\u003c/em\u003e. \u003cstrong\u003e135\u003c/strong\u003e, 27-35 (2009).\u003c/li\u003e\n\u003cli\u003eMota Junior, S.L., Hartmann, G.C., Vitral, R.F. \u0026amp; Tanaka, O.M. Efficacy of incisor movement with clear aligners: What about interval changes for aligners? \u003cem\u003eAm J Orthod Dentofacial Orthop\u003c/em\u003e. \u003cstrong\u003e160\u003c/strong\u003e, 4892021 (2021).\u003c/li\u003e\n\u003cli\u003eD\u0026apos;Anto, V., Bucci, R., De Simone, V., Huanca Ghislanzoni, L., Michelotti, A. \u0026amp; Rongo, R. Evaluation of Tooth Movement Accuracy with Aligners: A Prospective Study. \u003cem\u003eMaterials (Basel)\u003c/em\u003e. \u003cstrong\u003e15\u003c/strong\u003e (2022).\u003c/li\u003e\n\u003cli\u003eJaber, S.T., Hajeer, M.Y. \u0026amp; Burhan, A.S. The Effectiveness of In-house Clear Aligners and Traditional Fixed Appliances in Achieving Good Occlusion in Complex Orthodontic Cases: A Randomized Control Clinical Trial. \u003cem\u003eCureus\u003c/em\u003e. \u003cstrong\u003e14\u003c/strong\u003e, e30147 (2022).\u003c/li\u003e\n\u003cli\u003eChagas, A.S., Freitas, K.M.S., Can\u0026ccedil;ado, R.H., Valarelli, F.P., Canuto, L.F.G. \u0026amp; Oliveira, R.C.G. Level of satisfaction in the use of the wraparound Hawley and thermoplastic maxillary retainers. \u003cem\u003eAngle Orthod\u003c/em\u003e. \u003cstrong\u003e90\u003c/strong\u003e, 63-68 (2020).\u003c/li\u003e\n\u003cli\u003eElshazly, T.M., Bourauel, C., Aldesoki, M., Salvatori, D., Alhotan, A. \u0026amp; Keilig, L. Effect of attachment configuration and trim line design on the force system of orthodontic aligners: A finite element study on the upper central incisor. \u003cem\u003eOrthod Craniofac Res\u003c/em\u003e. \u003cstrong\u003e27\u003c/strong\u003e, Suppl 2(Suppl 2), 131-140 (2024). \u003c/li\u003e\n\u003cli\u003eThai, J.K., Araujo, E., McCray, J., Schneider, P.P. \u0026amp; Kim, K.B. Esthetic perception of clear aligner therapy attachments using eye-tracking technology. \u003cem\u003eAm J Orthod Dentofacial Orthop\u003c/em\u003e. \u003cstrong\u003e158\u003c/strong\u003e, 400-409 (2020)\u003c/li\u003e\n\u003cli\u003eLinjawi, A.I. \u0026amp; Abushal, A.M. Adaptational changes in clear aligner fit with time. \u003cem\u003eAngle Orthod\u003c/em\u003e. \u003cstrong\u003e92\u003c/strong\u003e, 220-225 (2022).\u003c/li\u003e\n\u003cli\u003eLoe, H. The Gingival Index, the Plaque Index and the Retention Index Systems. \u003cem\u003eJ Periodontol.\u003c/em\u003e \u003cstrong\u003e38\u003c/strong\u003e, Suppl:610-616 (1967).\u003c/li\u003e\n\u003cli\u003eFialho, T., de Freitas, K.M.S., Ohira, E.T.B., de Souza, J.E.P., de Oliveira, R.C.G, de Oliveira, R.C.G., Valarelli, F.P., Pinzan-Vercelino, C.R.M. \u0026amp; Cotrin, P. Comparison of the efficiency of initial dental alignment with Invisalign\u0026reg; aligners changed every 7 or 14\u0026thinsp;days in mature adults: Randomized clinical trial. \u003cem\u003eOrthod Craniofac Res\u003c/em\u003e. \u003cstrong\u003e27\u003c/strong\u003e, 544-551 (2024).\u003c/li\u003e\n\u003cli\u003eLevrini, L., Mangano, A., Montanari, P., Margherini, S., Caprioglio, A. \u0026amp; Abbate, G.M. Periodontal health status in patients treated with the Invisalign((R)) system and fixed orthodontic appliances: A 3 months clinical and microbiological evaluation. \u003cem\u003eEur J Dent\u003c/em\u003e. \u003cstrong\u003e9\u003c/strong\u003e, 404-410 (2015).\u003c/li\u003e\n\u003cli\u003ePogal-Sussman-Gandia, C.B., Tabbaa, S. \u0026amp; Al-Jewair, T. Effects of Invisalign (R) treatment on speech articulation. \u003cem\u003eInt Orthod\u003c/em\u003e. \u003cstrong\u003e17\u003c/strong\u003e, 513-518 (2019).\u003c/li\u003e\n\u003cli\u003eAntonio-Zancajo, L., Montero, J., Albaladejo, A., Oteo-Calatayud, M.D. \u0026amp; Alvarado-Lorenzo, A. Pain and Oral-Health-Related Quality of Life in Orthodontic Patients During Initial Therapy with Conventional, Low-Friction, and Lingual Brackets and Aligners (Invisalign): A Prospective Clinical Study. \u003cem\u003eJ Clin Med\u003c/em\u003e. \u003cstrong\u003e9\u003c/strong\u003e (2020).\u003c/li\u003e\n\u003cli\u003eFlores-Mir, C., Brandelli, J. \u0026amp; Pacheco-Pereira, C. Patient satisfaction and quality of life status after 2 treatment modalities: Invisalign and conventional fixed appliances. \u003cem\u003eAm J Orthod Dentofacial Orthop.\u003c/em\u003e \u003cstrong\u003e154\u003c/strong\u003e, 639-644 (2018).\u003c/li\u003e\n\u003cli\u003eNedwed, V. \u0026amp; Miethke, R.R. Motivation, acceptance and problems of invisalign patients. \u003cem\u003eJ Orofac Orthop\u003c/em\u003e. \u003cstrong\u003e66\u003c/strong\u003e, 162-173 (2005).\u003c/li\u003e\n\u003cli\u003eSharma, R., Drummond, R., Wiltshire, W., Schroth, R., Lekic, M. \u0026amp; Bertone M. Quality of life in an adolescent orthodontic population. \u003cem\u003eAngle Orthod\u003c/em\u003e. \u003cstrong\u003e91\u003c/strong\u003e, 718-724 (2021).\u003c/li\u003e\n\u003cli\u003eAlfawal, A.M.H., Burhan, A.S., Mahmoud, G., Ajaj, M.A., Nawaya, F.R. \u0026amp; Hanafi, I. The impact of non-extraction orthodontic treatment on oral health-related quality of life: clear aligners versus fixed appliances-a randomized controlled trial. \u003cem\u003eEur J Orthod\u003c/em\u003e. \u003cstrong\u003e44\u003c/strong\u003e, 595-602 (2022).\u003c/li\u003e\n\u003cli\u003eGao, M., Yan, X., Zhao, R., Shan, Y., Chen, Y. \u0026amp; Jian, F. Comparison of pain perception, anxiety, and impacts on oral health-related quality of life between patients receiving clear aligners and fixed appliances during the initial stage of orthodontic treatment. \u003cem\u003eEur J Orthod\u003c/em\u003e. \u003cstrong\u003e43\u003c/strong\u003e, 353-359 (2021).\u003c/li\u003e\n\u003cli\u003eAli Baeshen, H., El-Bialy, T., Alshehri, A., Awadh, W., Thomas, J. \u0026amp; Dhillon, H. The effect of clear aligners on speech: a systematic review. \u003cem\u003eEur J Orthod\u003c/em\u003e. \u003cstrong\u003e45\u003c/strong\u003e, 11-19 (2023).\u003c/li\u003e\n\u003cli\u003eFraundorf, E.C., Araujo, E., Ueno, H., Schneider, P.P. \u0026amp; Kim, K.B. Speech performance in adult patients undergoing Invisalign treatment. \u003cem\u003eAngle Orthod\u003c/em\u003e. \u003cstrong\u003e92\u003c/strong\u003e, 80-86 (2022).\u003c/li\u003e\n\u003cli\u003eLin, F., Yao, L., Bhikoo, C. \u0026amp; Guo, J. Impact of fixed orthodontic appliance or clear-aligner on daily performance, in adult patients with moderate need for treatment. \u003cem\u003ePatient Prefer Adherence.\u003c/em\u003e \u003cstrong\u003e10\u003c/strong\u003e, 1639-1645 (2016).\u003c/li\u003e\n\u003cli\u003eAzaripour, A., Weusmann, J., Mahmoodi, B., Peppas, D., Gerhold-Ay, A. \u0026amp; Van Noorden, C.J. Braces versus Invisalign(R): gingival parameters and patients\u0026apos; satisfaction during treatment: a cross-sectional study. \u003cem\u003eBMC Oral Health\u003c/em\u003e. \u003cstrong\u003e15\u003c/strong\u003e, 69 (2015).\u003c/li\u003e\n\u003cli\u003eRossini, G., Parrini, S., Castroflorio, T., Deregibus, A. \u0026amp; Debernardi, C.L. Periodontal health during clear aligners treatment: a systematic review. \u003cem\u003eEur J Orthod.\u003c/em\u003e \u003cstrong\u003e37\u003c/strong\u003e,539-543 (2015).\u003c/li\u003e\n\u003cli\u003eZhao, R., Huang, R., Long, H., Li, Y., Gao, M. \u0026amp; Lai, W. The dynamics of the oral microbiome and oral health among patients receiving clear aligner orthodontic treatment. \u003cem\u003eOral Dis\u003c/em\u003e. \u003cstrong\u003e26\u003c/strong\u003e, 473-483 (2020).\u003c/li\u003e\n\u003cli\u003eSaccomanno, S., Saran, S., Lagan\u0026agrave;, D., Mastrapasqua, R.F. \u0026amp; Grippaudo, C. Motivation, Perception, and Behavior of the Adult Orthodontic Patient: A Survey Analysis. \u003cem\u003eBiomed Res Int.\u003c/em\u003e \u003cstrong\u003e2022\u003c/strong\u003e, 2754051 (2022).\u003c/li\u003e\n\u003cli\u003eLyu, X., Cao, X., Yan, J., Zeng, R. \u0026amp; Tan, J. Biomechanical effects of clear aligners with different thicknesses and gingival-margin morphology for appliance design optimization. \u003cem\u003eAm J Orthod Dentofacial Orthop\u003c/em\u003e. \u003cstrong\u003e164\u003c/strong\u003e, 239-252 (2023).\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 to 3 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Orthodontics, Malocclusion, Orthodontic Appliances, Removable","lastPublishedDoi":"10.21203/rs.3.rs-6784996/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6784996/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective:\u003c/strong\u003eThis prospective clinical study compared the overall patient perception and periodontal health using in-office clear aligners with two gingival margin level heights (gingival level and 2 mm up to the gingival level).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMaterial and Methods:\u003c/strong\u003e The sample comprised 23 patients treated with in-office clear aligners. The mean age was 28.74 years. The mean initial maxillary and mandibular irregularity indexes were 3.95 and 3.66mm, respectively. Twelve patients started using 2 pairs of aligners trimmed at the gingival margin level (0mm), and 11 patients using 2 pairs of aligners trimmed 2 mm above the gingival margin level. Each set of aligners was used for 14 days. The total evaluation time was 2 months. The Gingival Index Bleed was performed at the end of the use of each type of aligner. On Google Forms, patients answered a 9-item questionnaire about their perception of comfort, adaptation, speech, and swallowing while using the 2 aligners. The Wilcoxon test was used to compare the questionnaire grades. Dependent t-test compared the G.I. Descriptive statistics were used to determine aligner preference.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e There was no statistically significant difference between the two heights of gingival margin levels in the nine evaluated items. Most patients preferred the 0mm, with comfort and adaptation as the main reason for the choice Those who opted for gingival margin height up to 2 mm mentioned good fit, adaptation, and retention as the main reasons. \u003cstrong\u003eConclusion:\u003c/strong\u003e The patient's perception was similar for speaking, cleaning, esthetics, fit, and retention with the 2 evaluated heights. However, most of the patients preferred the aligners trimmed at the gingival level.\u003c/p\u003e","manuscriptTitle":"Comparison of patient adaptation with in-office aligners with two different levels of the gingival margin","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-06-10 11:24:14","doi":"10.21203/rs.3.rs-6784996/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"1c2fc247-0276-4fcf-8e77-8719888cdc7e","owner":[],"postedDate":"June 10th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":49631499,"name":"Health sciences/Health care/Dentistry/Orthodontics"},{"id":49631500,"name":"Health sciences/Health care/Quality of life"}],"tags":[],"updatedAt":"2025-11-24T06:24:04+00:00","versionOfRecord":[],"versionCreatedAt":"2025-06-10 11:24:14","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6784996","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6784996","identity":"rs-6784996","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}