Tooth Whitening With Hydrogenperoxide in Adolescents

University of Nove de Julho

Status: Unknown

Conditions: Posteruptive Color Change of Tooth

Treatments: Other: 7.5% hydrogen peroxide - Oral-B 3D White; Other: 7.5% hydrogen peroxide - White Class; Other: 6.0% hydrogen peroxide - White Class; Other: Placebo gel without hydrogen peroxide

Study type: Interventional

Funder types: Other

Identifiers

NCT01998386

TWHPA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 12 to 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 4 patient groups, including a placebo group

Placebo gel without hydrogen peroxide

Placebo Comparator group

Description:

The volunteers of this group will receive a placebo gel without hydrogen peroxide for whitening treatment.

Treatment:

Other: Placebo gel without hydrogen peroxide

6.0% hydrogen peroxide - White Class

Experimental group

Description:

Volunteers of this group will receive a gel with 6.0% hydrogen peroxide - White Class with calcium for whitening treatment.

Treatment:

Other: 6.0% hydrogen peroxide - White Class

7.5% hydrogen peroxide - White Class

Experimental group

Description:

The volunteers of this group will receive a gel with 7.5% hydrogen peroxide -White Class with calcium for whitening treatment.

Treatment:

Other: 7.5% hydrogen peroxide - White Class

7.5% hydrogen peroxide - Oral-B 3D White

Experimental group

Description:

The participants in this group will receive disposable whitening strips - Oral-B 3D White for whitening treatment.

Treatment:

Other: 7.5% hydrogen peroxide - Oral-B 3D White