At-home Bleaching Using Clear Aligners

Study Overview
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Brief Summary
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The aim of the present project is to clinically evaluate the bleaching effectiveness, tooth sensitivity, gingival irritation and patient´s satisfaction during a at-home bleaching with 10% carbamide peroxide using a conventional bleaching tray or a clear aligner.

Detailed Description
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Forty patients (n=40) will be randomized as to which side will receive the type of bleaching tray, conventional or clear aligner. The at-home bleaching will be performed with 10% carbamide peroxide (Opalescence PF 10%) for 2 hours for 4 weeks. The color will be assessed at baseline, after one, two, four weeks, and at 1 month after bleaching treatment using subjective color guides (VITA Classical and VITA Bleachguide 3D-MASTER) and a objective digital spectrophotometer (VITA Easyshade). The intensity and absolute risk of tooth sensitivity and gingival irritation will also be determined with a visual analog scale (EVA 0-10). Patient´s satisfaction will be evaluated at baseline, after one and two weeks, and at 1 month after bleaching treatment with an apropriate questionnaire using a visual analog scale (EVA 0-10). Color change between groups will be compared by paired Student´s t-test. The absolute risk of tooth sensitivity and gingival irritation for both groups will be compared by McNemar test. Also, odds ratios, confidence intervals, and Spearman correlation will be determined. The intensity of tooth sensitivity, gingival irritation and patient´s satisfaction will be compared by paired Student´s t-test. The level of statistical significance accepted will be 5% for all analyses.

Official Title
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At-home Bleaching With the Use of Clear Aligners: Randomized Single-blind Equivalence Clinical Trial

Conditions
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Tooth Discoloration, Tooth Sensitivity, Gingivitis, Satisfaction, Patient

Intervention / Treatment
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* Other: Whitening


Participation Criteria
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Eligibility Criteria
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The inclusion criteria will be the following: Patients over 18 years of age. Patients with vital teeth without restorations, single crowns, implants and/or bridges at the level of the anterior teeth. Absence of cavities in the teeth to be whitened. Patients with satisfactory oral hygiene, and periodontally healthy, who are not undergoing periodontal maintenance and who do not use chlorhexidine rinses. Patients with recessions without sensitivity are included. Absence of sensitivity, measured based on stimulation with the air from the syringe. Patients who are at least in A2-A3 color (Vita Classic Guide) The exclusion criteria will be the following: Patients who have previously undergone whitening (less than 5 years). Patients undergoing orthodontic treatment. Patients with white spot or developmental alterations (dentinogenesis imperfecta, amelogenesis imperfecta) or with stains (tetracyclines or fluorosis). Patients with a history of trauma to anterior teeth. Patients who require internal whitening. Smokers. Pregnant or lactating women. Allergy to any component of whitening. Alterations of the oral mucosa (desquamative gingivitis, OLP, leukoplakias, etc.). Medical conditions considered by the researchers that may compromise the study or the individual safety of the patient. Patients with poor oral hygiene. Patients with previous hypersensitivity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is a randomized, single blind (evaluators), split mouth and equivalence study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional tray<br>Two simple randomizations will be performed using a software program freely available online (www.sealedenvelop.com). For the first randomization, for each participant, the group (type of tray) will be randomized and it will always be applied to the participant's right hemiarch (n=40) according to the model: conventional tray or clear aligner. Subsequently, the second randomization will be carried out, which will define the alternate days for the use of the tray and the aligner: Monday, Wednesday and Friday or Tuesday, Thursday and Saturday. | Other: Whitening<br>* Two syringes of 10% carbamide peroxide bleaching gel will be provided for use with each type of tray. Volunteers will be instructed to use the whitening gel once a day for 2 hours, for 3 days per week with each tray, completing a total of 4 weeks of whitening procedure.<br>|
| Active Comparator: Clear aligner<br>The patients will use the clear aligner on their right hemiarch and according to the second randomization it will be applied on Monday, Wednesday and Friday or Tuesday, Thursday and Saturday. | Other: Whitening<br>* Two syringes of 10% carbamide peroxide bleaching gel will be provided for use with each type of tray. Volunteers will be instructed to use the whitening gel once a day for 2 hours, for 3 days per week with each tray, completing a total of 4 weeks of whitening procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Color change evaluation | The color will be assessed using subjective color guides (VITA Classical and VITA Bleachguide 3D-MASTER) and a objective digital spectrophotometer (VITA Easyshade). | Baseline, after one, two, four weeks, and at 1 month after bleaching treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity and absolute risk of tooth sensitivity | They will be determined by means of a visual analog scale (EVA), using a conventional bleaching tray or a clear aligner, during at home bleaching treatment with 10% carbamide peroxide. | Baseline, after one, two, four weeks, and at 1 month after bleaching treatment | 
| Intensity and absolute risk of gingival irritation | They will be determined by means of a visual analog scale (EVA), using a conventional bleaching tray or a clear aligner, during at home bleaching treatment with 10% carbamide peroxide. | Baseline, after one, two, four weeks, and at 1 month after bleaching treatment | 
| Patient´s satisfaction | It will be measured with a questionnaire using a visual analog scale (EVA), when a conventional bleaching tray or a clear aligner is used to perform a at home bleaching treatment with 10% carbamide peroxide. | Baseline, after one, two, four weeks, and at 1 month after bleaching treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clear aligner, At-home tooth bleaching, Tooth sensitivity, Gingival irritation, Patient´s satisfaction