Combined Dental Bleaching Protocols and Time Required to Achieve Satisfactory Color

Study Overview
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Brief Summary
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This parallel, randomized, and controlled clinical trial will assess the effect of a single prior session of in-office dental bleaching on time required to achieve satisfactory tooth color with at-home bleaching. Participants enrolled will randomly allocated to receive or not a single session of dental bleaching with 35% hydrogen peroxide applied for 45 min. Following, all participants will use customized trays filled with 10% carbamide peroxide for 1h per day until obtain satisfactory results. The primary outcome will be the number of days necessary to obtain satisfactory tooth color. Furthermore, tooth sensitivity and color changes measured with spectrophotometer will be assessed.

Official Title
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Effect of a Single Prior Session of In-office Dental Bleaching on Time Required to Obtain Satisfactory Tooth Color With At-home Bleaching

Conditions
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Tooth Discoloration

Intervention / Treatment
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* Drug: Bleaching Agents
* Drug: Bleaching Agents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general and oral health; Upper canines darker than the tab 2.5M2 at VITA Bleachedguide 3D-MASTER® (Vita-Zahnfabrik, Bad Sackingen, Germany) scale. Exclusion Criteria: Presence of non-treated caries or periodontal disease; Prior tooth hypersensitivity; Presence of gingival recession; Teeth with cracked enamel or any hypoplasia; Patients using oral removable or fixed orthodontic appliances; Patients were pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined technique<br>A single session of in-office tooth bleaching will be performed with 35% hydrogen peroxide for 45 minutes. Following, the teeth will be further bleached with customized trays filled with 10% carbamide peroxide and used for 1h per day. | Drug: Bleaching Agents<br>* In-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes.<br>Drug: Bleaching Agents<br>* At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.<br>|
| Active Comparator: At-home bleaching<br>The teeth will be bleached only with customized trays filled with 10% carbamide peroxide and used for 1h per day. | Drug: Bleaching Agents<br>* At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tooth color satisfaction | Time in days performing at-home bleaching necessary to participant reports that is satisfied with the tooth color obtained | up to 1 month after beginning the tooth bleaching procedures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Color change | Values of delta E measured with a spectrophotometer from color at baseline | up to 1 month after beginning the tooth bleaching procedures | 
| Tooth sensitivity | Maximum level of tooth sensitivity reported by participants using an analogue visual scale. The distance between the patient's marking and the no pain border was recorded in cm. | 1, 2, 3, and 4 week after beginning the tooth bleaching procedures | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth bleaching, Hydrogen peroxide, Carbamide peroxide, Tooth Bleaching Agents