Tooth Whitening With Hydrogenperoxide in Adolescents
- Conditions
- Posteruptive Color Change of Tooth
- Interventions
- Other: Placebo gel without hydrogen peroxideOther: 6.0% hydrogen peroxide - White ClassOther: 7.5% hydrogen peroxide - White ClassOther: 7.5% hydrogen peroxide - Oral-B 3D White
- Registration Number
- NCT01998386
- Lead Sponsor
- University of Nove de Julho
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 64
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo gel without hydrogen peroxide Placebo gel without hydrogen peroxide The volunteers of this group will receive a placebo gel without hydrogen peroxide for whitening treatment. 6.0% hydrogen peroxide - White Class 6.0% hydrogen peroxide - White Class Volunteers of this group will receive a gel with 6.0% hydrogen peroxide - White Class with calcium for whitening treatment. 7.5% hydrogen peroxide - White Class 7.5% hydrogen peroxide - White Class The volunteers of this group will receive a gel with 7.5% hydrogen peroxide -White Class with calcium for whitening treatment. 7.5% hydrogen peroxide - Oral-B 3D White 7.5% hydrogen peroxide - Oral-B 3D White The participants in this group will receive disposable whitening strips - Oral-B 3D White for whitening treatment.
- Primary Outcome Measures
Name Time Method Discoloration Change of teeth color after 7 days of the beginning of treatment 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.
- Secondary Outcome Measures
Name Time Method Dental sensitivity Sensivity alteration after 7 days of the beginning of treatment 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.
Trial Locations
- Locations (1)
University of Nove de Julho
🇧🇷Sao Paulo, Brazil