Efficacy in the Reduction of Hypersensitivity During Home Whitening With 16% Carbamide Peroxide Applied on Alternate Days

Study Overview
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Brief Summary
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The concentration of 16% carbamide peroxide is the highest concentration that European regulations allow for use in home whitening (Council directive 2011/84/EU). This concentration allows for faster results, but instead patients may suffer more frequently from dental sensitivity. The most commonly described side effect of all whitening procedures is the appearance of dentin hypersensitivity, hence the efforts to counteract or overcome this adverse effect. The objective of the study is to clinically evaluate the difference in dental hypersensitivity produced by home dental whitening treatment using 16% carbamide peroxide in a tray for two hours daily applied daily or every other day for three weeks.

Detailed Description
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Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a total of 3 weeks of whitening procedure. Depending on the randomization, the bleaching procedure will be performed every other day or daily. In the upper arch, the teeth to be whitened will be from 15 to 25. The evaluations of efficacy, dental sensitivity and satisfaction will be carried out in the upper and lower arch. The color will be recorded before, weekly for 1 month, 6 months and 12 months after finishing the treatment. Shade assessment using the subjective method will be recorded with the Vita Classical color scale (Vita Zahnfabrik, Bad Säckingen, Germany), it will also be determined with the Vita 3D-MASTER scale (Vita Zahnfabrik, Bad Säckingen, Germany). For objective evaluation, the Vita Easyshade spectrophotometer (Vita Zahnfabrik, Bad Säckingen, Germany) will be used, according to the CIEL*a*b* system.

Official Title
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Efficacy in the Reduction of Hypersensitivity During Home Whitening With 16% Carbamide Peroxide Applied on Alternate Days: a Randomized Clinical Trial

Conditions
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Dental Hypersensitivity, Teeth Whitening

Intervention / Treatment
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* Other: Daily whitening
* Other: Alternate whitening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years. 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 mouthwashes. Patients with recessions without presenting sensitivity will be included. Absence of sensitivity, measured with the application of air with the dental team's syringe. Patients whose canines have at least an A2-A3 shade (VITA Classic® Guide). Exclusion Criteria: Patients who have previously undergone whitening (less than 5 years). Patients undergoing orthodontic treatment. Patients with white spots or alterations in the development of enamel or with stains. Patients with a history of trauma to anterior teeth. Patients who require internal whitening. Smokers. Pregnant or lactating. Patients with allergies to any whitening component. Patients presenting alterations of the oral mucosa (desquamative gingivitis, oral lichen planus, leukoplakia, etc.). Patients with 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

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: Parallel Assignment
Interventional Model Description: Each volunteer will be given 3 syringes of 16% carbamide peroxide bleaching gel to use on the splint. Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a total of 3 weeks of whitening procedure. Depending on the randomization, the whitening procedure will be performed on alternate days or daily. In the upper arch, the teeth to be whitened will be from 15 to 25 and in the lower one from 35 to 45.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Daily whitening<br>Volunteers should whiten daily with a whitening tray from 15 to 25 and 35 to 45 for 2 hours. This procedure will last 3 weeks. | Other: Daily whitening<br>* Daily application of a 16% carbamide peroxide bleaching gel in volunteers without sensitivity.<br>|
| Experimental: Alternate whitening<br>Volunteers will bleach for 3 weeks with 16% carbamide peroxide, alternating one rest day for each placement day. They will wear a whitening tray from 15 to 25 and from 35 to 45 for 2 hours. | Other: Alternate whitening<br>* Volunteers will apply the whitening gel at 16% carbamide peroxide, alternating a rest day with an application day. Patients should not be sensitive before starting the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Sensitivity | The objective of the study is to clinically evaluate the appearance of dental sensitivity produced by the home dental whitening treatment using 16% carbamide peroxide applied in a tray for two hours daily each day or using it on alternate days for three weeks. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whitening efficacy | To assess whether the efficacy of the 16% carbamide peroxide whitening treatment described above applied every other day is the same as when used every day or is there a difference in whitening efficacy. This will be determined instrumentally with the Vita EasyShade V® spectrophotometer, based on the CIEL*a*b* system, according to the CIELAB, CIEDE2000 system and the whiteness index. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bleaching, hipersensitivity, whitening, at-home, carbamide