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| Name | Class |
|---|---|
| Align Technology, Inc. | INDUSTRY |
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The aim of this project is to clinically evaluate patient satisfaction, whitening efficacy, tooth sensitivity, and gingival irritation during at-home whitening with 10% carbamide peroxide using an Essix-type retainer or a Vivera retainer.
Forty patients (n=40) will be randomized as to which side will receive the type of bleaching tray, essix-type retairner or Vivera retainer. The at-home bleaching will be performed with 10% carbamide peroxide (Opalescence PF 10%) for 2 hours The treatment lasted 4 weeks, although as each retainer was worn every other day, the actual application time was 2 weeks. Patient´s satisfaction will be evaluated at baseline, after one, two weeks, and 4 weeks with an apropriate questionnaire using a visual analog scale (EVA 0-10). The color will be assessed at baseline, after one, two and four weeks 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). 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essix-type retairner | Active Comparator | 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: essix-type retairner or Vivera retainer. Subsequently, the second randomization will be carried out, which will define the alternate days for the use of essix-type retairner and Vivera retainer: Monday, Wednesday and Friday or Tuesday, Thursday and Saturday. |
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| Vivera retainer | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whitening | Other | 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 retainer, completing a total of 4 weeks of whitening procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient´s satisfaction | It will be measured with a questionnaire using a visual analog scale (EVA), when a essix-type retairner or Vivera retainer is used to perform a at home bleaching treatment with 10% carbamide peroxide. | Baseline, after one, two and four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Color change evaluation | The color will be assesed using subjetive color guides (VITA Classical and VITA 3D-MASTER) and a objetive digital spectrophotometer (VITA Easyshade). | Baseline, after one, two and four weeks |
| Intensity and absolute risk of tooth sensitivity |
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The inclusion criteria will be the following:
The exclusion criteria will be the following:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Dental Iturralde | Tafalla | Navarre | 31300 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22408775 | Background | Almeida LC, Riehl H, Santos PH, Sundfeld ML, Briso AL. Clinical evaluation of the effectiveness of different bleaching therapies in vital teeth. Int J Periodontics Restorative Dent. 2012 Jun;32(3):303-9. | |
| 35128627 | Background | Carneiro TS, Favoreto MW, Bernardi LG, Sutil E, Wendlinger M, Centenaro GG, Reis A, Loguercio AD. Gingival irritation in patients submitted to at-home bleaching with different cutouts of the bleaching tray: a randomized, single-blind clinical trial. Clin Oral Investig. 2022 Jun;26(6):4381-4390. doi: 10.1007/s00784-022-04401-4. Epub 2022 Feb 7. |
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| ID | Term |
|---|---|
| D014075 | Tooth Discoloration |
| D003807 | Dentin Sensitivity |
| D005891 | Gingivitis |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
| D005882 | Gingival Diseases |
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This is a randomized, single blind (evaluators), split mouth and equivalence study.
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It will be a single-blind study in which only the evaluator will not know the designation of the groups because he has not participated in the study's randomization and implementation process. Due to the tray test and demonstration of the bleaching procedure, the operator and the participant cannot be blinded.
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They will be determined by means of a visual analog scale (EVA), using a essix-type retairner or Vivera retainer, 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 essix-type retairner or Vivera retainer, during at home bleaching treatment with 10% carbamide peroxide. | Baseline, after one, two, four weeks, and at 1 month after bleaching treatment |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |