Tooth Whitening With Hydrogenperoxide in Adolescents

Not Applicable

• Conditions: Posteruptive Color Change of Tooth

• 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.

Study Timeline

• Status Verified: 2013-09
• Study First Submitted: 2013-09-15
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-23
• Last Update Submitted: 2013-11-23
• Study First Posted: 2013-11-28
• Last Update Posted: 2013-11-28
• Primary Completion: 2014-03
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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