Tooth Whitening With Hydrogenperoxide in Adolescents

Study Overview
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Brief Summary
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The specific objective of this study is: Evaluate and quantify colorimetric changes in young permanent anterior teeth; Compare the efficiency and efficacy of three gels used for self-administered home whitening and an over the counter whitening strip; Analyze the increase in dental sensitivity in adolescent patients submitted to home whitening with 6% and 7.5% hydrogen peroxide with and without the addition of calcium (whitening strips); Assess sensitivity, comfort and acceptance of whitening strips by patients; Assess patient satisfaction with the method and material used for home whitening.

Detailed Description
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The aim of the proposed controlled clinical trial will be to assess colorimetric changes and increased dental sensitivity in adolescent patients submitted to tooth whitening with 6% and 7.5% hydrogen peroxide using home kits with whitening strips. Adolescents aged 12 to 20 years will be allocated to different groups based on treatment (n = 16 per group): 1) placebo; 2) 6.0% hydrogen peroxide (White Class with calcium - FGM); 3) 7.5% hydrogen peroxide (White Class with calcium - FGM); and 4) 7.5% hydrogen peroxide (Oral B 3D White - Oral-B). After the whitening procedures, the participants will be evaluated using a visual analogue scale for tooth sensitivity and digital spectrophotometry for the measurement of changes in color.

Official Title
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Tooth Whitening With Hydrogenperoxide in Adolescents - Controlled Clinical Trial

Conditions
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Posteruptive Color Change of Tooth

Intervention / Treatment
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* Other: Placebo gel without hydrogen peroxide
* Other: 6.0% hydrogen peroxide - White Class
* Other: 7.5% hydrogen peroxide - White Class
* Other: 7.5% hydrogen peroxide - Oral-B 3D White


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 12 to 20 years; diagnosis of altered color on maxillary and mandibular anterior teeth with initial color equivalent to A2 on the Vita scale (Vita Zahnfabrik); signed statement of informed consent Exclusion Criteria: Dental anomalies (malformation, carious lesions, fractures); presence of at least four maxillary and/or mandibular anterior teeth; known adverse reaction to peroxide; use of whitening agents (administered in dental office or at home) in the previous year; currently undergoing orthodontic treatment, orthopedic treatment of the jaws or psychological treatment; use of medication that can alter the color of the teeth, such as ferrous sulfate.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Placebo Comparator: Placebo gel without hydrogen peroxide<br>The volunteers of this group will receive a placebo gel without hydrogen peroxide for whitening treatment. | Other: Placebo gel without hydrogen peroxide<br>* Castings will be made of the upper and lower arches of the volunteers and plaster will be poured into the molds. Individual plastic molds (vacuum form, flexible acetate 1 mm in thickness) will be made for each arch using the plaster models. After fitting the molds in the oral cavity, the volunteers will receive oral and written instructions on how to use the whitening gel and will be instructed to perform proper oral hygiene with dental floss and a tooth brush prior to the application of the whitening agent. The volunteers will be instructed to use the molds with the gel one hour a day for seven days. Thirty days after the beginning of treatment, the volunteers in this group will receive the whitening treatment with 6.0% hydrogen peroxide - White Class with calcium.<br>|
| Experimental: 6.0% hydrogen peroxide - White Class<br>Volunteers of this group will receive a gel with 6.0% hydrogen peroxide - White Class with calcium for whitening treatment. | Other: 6.0% hydrogen peroxide - White Class<br>* Castings will be made of the upper and lower arches of the volunteers and plaster will be poured into the molds. Individual plastic molds (vacuum form, flexible acetate 1 mm in thickness) will be made for each arch using the plaster models. After fitting the molds in the oral cavity, the volunteers will receive oral and written instructions on how to use the whitening gel 6.0% hydrogen peroxide - White Class with calcium and will be instructed to perform proper oral hygiene with dental floss and a tooth brush prior to the application of the whitening agent. The volunteers will be instructed to use the molds with whitening gel one hour a day for seven days.<br>|
| Experimental: 7.5% hydrogen peroxide - White Class<br>The volunteers of this group will receive a gel with 7.5% hydrogen peroxide -White Class with calcium for whitening treatment. | Other: 7.5% hydrogen peroxide - White Class<br>* Castings will be made of the upper and lower arches of the volunteers and plaster will be poured into the molds. Individual plastic molds (vacuum form, flexible acetate 1 mm in thickness) will be made for each arch using the plaster models. After fitting the molds in the oral cavity, the volunteers will receive oral and written instructions on how to use the whitening gel 7.5% hydrogen peroxide - White Class with calciumand will be instructed to perform proper oral hygiene with dental floss and a tooth brush prior to the application of the whitening agent. The volunteers will be instructed to use the molds with whitening gel one hour a day for seven days.<br>|
| Experimental: 7.5% hydrogen peroxide - Oral-B 3D White<br>The participants in this group will receive disposable whitening strips - Oral-B 3D White for whitening treatment. | Other: 7.5% hydrogen peroxide - Oral-B 3D White<br>* The participants in this group will receive four disposable whitening 7.5% hydrogen peroxide - Oral-B 3D White strips for daily individual use. The volunteers will be instructed to perform proper oral hygiene with dental floss and a tooth brush prior to the application of the whitening strips. The volunteers will receive oral and written instructions on how to use the whitening strips, which will be placed on the surface of the teeth for 30 minutes twice a day for seven days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discoloration | Color readings of the vestibular region of the maxillary and mandibular anterior teeth will be performed by a previously trained examiner blinded to the allocation of the volunteers to the different groups. A digital spectrophotometer will be used for the colorimetric evaluation. It will be carried out in all groups at the following times: pre-treatment period, immediately following the first treatment period, after seven days, after 30 days, after six months, after 12 months, after 24 months, and after 48 months. | Change of teeth color after 7 days of the beginning of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental sensitivity | The volunteers will inform the degree of sensitivity at all evaluation times using a visual analog scale ranging from 0 (absence of sensitivity) to 10 (maximum sensitivity). Evaluations of dental sensitivity will be carried out in all groups at the following times: pre-treatment period, immediately following the first treatment period, after seven days, after 30 days, after six months, after 12 months, after 24 months and after 48 months. | Sensivity alteration after 7 days of the beginning of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth Whitening, Adolescent, Clinical Trial