NCT01998386

Tooth Whitening With Hydrogenperoxide in Adolescents

Tooth Whitening With Hydrogenperoxide in Adolescents - Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 12 Years – 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Posteruptive Color Change of Tooth

Interventions

Type	Name	Description
OTHER	Placebo gel without hydrogen peroxide	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.
OTHER	6.0% hydrogen peroxide - White Class	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.
OTHER	7.5% hydrogen peroxide - White Class	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.
OTHER	7.5% hydrogen peroxide - Oral-B 3D White	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.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-03-01
• Completion: 2017-09-01
• First posted: 2013-11-28
• Last updated: 2013-11-28

Locations

1 site across 1 country: Brazil