In-office and At-home Tooth Bleaching Using Low Concentration Peroxides.

Study Overview
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Brief Summary
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To evaluate the efficacy, safety and impact on quality of life related to oral health of home and office tooth whitening techniques in young individuals.

Detailed Description
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The aim of this study is to evaluate the efficacy, safety and impact on quality of life related to oral health of tooth whitening techniques in young individuals. It will be a randomized, parallel and single blind. Participants are divided into three groups (n = 30) according to bleaching technique to be performed (G1 = Office / hydrogen peroxide 6%; G2 = Office / hydrogen peroxide 15%; G3 = Home / carbamide peroxide 10%). The color of the teeth will be evaluated in seven different times, using the color scale Vita Master Classic 3D and spectrophotometer Vita Easy Shade Advance. IGM (1986) - the presence of tooth sensitivity by visual analogue scale and gingival security through modified gingival index will be evaluated. The impact of bleaching quality of life will be assessed using the Brazilian version of the oral impact on daily performance (OIDP). The instrument will be applied in interview form at two different times at baseline (T0) and thirty days after the first evaluation (T4). Statistical analysis include descriptive analysis and testing to compare the two bleaching techniques as the color change, sensitivity, gum irritation and impact on quality of life.

Official Title
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In-office and At-home Tooth Bleaching Using Low Concentration Peroxides.: Effectiveness, Security and Impact on Quality of Life Related to Oral Health

Conditions
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Discolored Teeth

Intervention / Treatment
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* Drug: hydrogen peroxide 6%
* Drug: hydrogen peroxide 15%
* Drug: Carbamide Peroxide 10%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: tooth color ranging from A3 or darker, teeth with no stains and restorations without whitening experience Exclusion Criteria: participants with gingivitis and periodontal disease, the total biofilm accumulation greater than 30%, severe crowding dental, smoking with tooth sensitivity and pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - HP 6%<br>Group 1: Experimental: Office; hydrogen peroxide 6%, | Drug: hydrogen peroxide 6%<br>* Office; hydrogen peroxide 6%, 3 sessions of 20 minutes of application<br>* Other names: Group 1 - HP 6%;|
| Experimental: Group 2 - HP 15%<br>Group 2: Experimental: Office; hydrogen peroxide 15%, | Drug: hydrogen peroxide 15%<br>* Office; hydrogen peroxide 15%, 3 sessions of 20 minutes of application<br>* Other names: Group 2 - HP 15%;|
| Active Comparator: Group 3 - CP 10%<br>Group 3: Control: Homemade; Carbamide Peroxide 10%, | Drug: Carbamide Peroxide 10%<br>* Homemade; Carbamide Peroxide 10%, 2 hours per day for 21 days<br>* Other names: Group 3 - CP 10%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of color change | Visual evaluation using color scale Vita Classical 3D Master (Vita Zahnfabrik, Germany); (B1, A1, B2, D2, A2, C1, C2, D4, A3, D3, B3, A3.5, B4, C3, A4, C4) Quantitative evaluation using a spectrophotometer Easy Shade Advance ® (Wilcos Brazil). System CIE L * a * b * - L represents the value (lightness or darkness), the value of a * is a measure red (positive a *) or green (negative a *); the value of b * is a yellow extent (b * positive) or blue (b * negative) and the color difference between the color coordinate is calculated as ΔE * = [(ΔL *) 2 + (Δa *) 2 + (Δb *) 2] 1/2. | T0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months ;T6:After 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth sensitivity assessment | It will be registered according to the Visual Analogue Scale (VAS), according to the criteria: none, mild, moderate or severe. | T0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment; | 
| Evaluation of gingival irritation | The Modified Gingival Index (IGM) The criteria are as follows: 0: Absence of inflammation;1: mild inflammation - slight change in color and texture of the gum; 2: mild inflammation involving the entire gingival margin; 3: moderate inflammation, shiny surface and edema; 4: Severe inflammation, spontaneous bleeding and severe edema. | T0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment; | 
| Impact assessment on quality of life | The Brazilian version of the oral impact on daily performance (OIDP) will be used to assess the impact on quality of life. The instrument will be applied in interview form at two different times at baseline (T0) and thirty days after the first evaluation (T4) to assess the perception of changes in oral health after treatment. | T0 (Baseline): Before treatment;T4: After 30 days of starting treatment; | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbamide peroxide, Hydrogen peroxide, Quality of life