NCT02414464

Tooth Bleaching for Young Patients Using a Hydrogen Peroxide-based Gel

In-Office Tooth Bleaching for Young Patients Using a Hydrogen Peroxide-based Gel: a Randomized, Controlled, Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 11 Years – 24 Years
• Healthy volunteers: Accepted

Summary

The aim of the present study was to evaluate colorimetric changes and tooth sensitivity in young patients submitted to tooth bleaching with 20% and 35% hydrogen peroxide.

Detailed description

A randomized, controlled, clinical trial was conducted with 53 patients aged 11 to 24 years who were allocated to groups based on the use of the following commercial products: Whiteness HP - FGM® (35% hydrogen peroxide); Whiteness HP Blue Calcium - FGM® (35% hydrogen peroxide); and Whiteness HP Blue Calcium - FGM® (20% hydrogen peroxide). After the bleaching procedure, the visual analog scale was used to measure tooth sensitivity and the classic Vita® scale was used to determine changes in tooth color. Statistical analysis involved the Friedman, Kruskal-Wallis and Student-Newman-Keuls tests, with p-value ≤ 0.05 or ≤ 0.0001 considered indicative of statistical significance.

Conditions

• Tooth Discoloration

Interventions

Type	Name	Description
OTHER	35% hydrogen peroxide	Prophylaxis was performed with a jet of sodium bicarbonate to remove extrinsic pigments and plaque. Each patient underwent two bleaching sessions. A lip retractor (Arc Flex, FGM®) was placed. Cotton roles or gauze compresses were used to achieve relative isolation. A dental dam (Top Dam, FGM®) was placed over the free marginal gingival tissue and the inter-tooth papillae of teeth 14 to 24 in each session. The Whiteness HP 35% gel was applied to the vestibular faces of these teeth. In the present study, the Whiteness HP 35% gel was applied without an external auxiliary source. As this is not a self-catalyzed system, the gel was removed after each 15-minute application and reapplied two more times, totaling 45 minutes of contact with the teeth.
OTHER	35% hydrogen peroxide	Prophylaxis was performed with a jet of sodium bicarbonate to remove extrinsic pigments and plaque. Each patient underwent two bleaching sessions. A lip retractor (Arc Flex, FGM®) was placed. Cotton roles or gauze compresses were used to achieve relative isolation. A dental dam (Top Dam, FGM®) was placed over the free marginal gingival tissue and the inter-tooth papillae of teeth 14 to 24 in each session. The Whiteness HP Blue Calcium 35% gel was applied to the vestibular faces of these teeth for 40 minutes in each session.
OTHER	20% hydrogen peroxide	Prophylaxis was performed with a jet of sodium bicarbonate to remove extrinsic pigments and plaque. Each patient underwent two bleaching sessions. A lip retractor (Arc Flex, FGM®) was placed. Cotton roles or gauze compresses were used to achieve relative isolation. A dental dam (Top Dam, FGM®) was placed over the free marginal gingival tissue and the inter-tooth papillae of teeth 14 to 24 in each session. The Whiteness HP Blue Calcium 20% gel was applied to the vestibular faces of these teeth 50 minutes in each session.

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-09-01
• Completion: 2015-05-01
• First posted: 2015-04-10
• Last updated: 2018-05-02