Overview

This trial is active, not recruiting.

Condition tooth discoloration
Treatments 35% hydrogen peroxide, 20% hydrogen peroxide
Sponsor University of Nove de Julho
Start date February 2013
End date September 2014
Trial size 53 participants
Trial identifier NCT02414464, TBYP

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Volunteers of this group will receive a gel with 35% hydrogen peroxide - Whiteness HP 35% for whitening treatment.
35% hydrogen peroxide Whiteness HP 35%
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.
(Experimental)
Volunteers of this group will receive a gel with 35% hydrogen peroxide with calcium - Whiteness HP Blue Calcium 35% for whitening treatment.
35% hydrogen peroxide Whiteness HP Blue Calcium 35%
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.
(Experimental)
Volunteers of this group will receive a gel with 35% hydrogen peroxide with calcium - Whiteness HP Blue Calcium 20% for whitening treatment.
20% hydrogen peroxide Whiteness HP Blue Calcium 20%
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.

Primary Outcomes

Measure
Discoloration
time frame: Change of teeth color after 48 hours, after 6 months, after 12 months, after 18 months

Secondary Outcomes

Measure
Dental sensitivity
time frame: Sensivity alteration up to 48 hours after the procedure

Eligibility Criteria

Male or female participants from 11 years up to 24 years old.

Inclusion Criteria: - Individuals aged 11 to 24 years with a diagnosis of tooth discoloration and a signed statement of informed consent. Exclusion Criteria: - Individuals with dentofacial anomalies, those without the permanent dentition complete to the second molars, those in orthodontic or orthopedic treatment of the jaws, those who took medications that could alter tooth color and those who had previously been submitted to tooth bleaching

Additional Information

Official title In-Office Tooth Bleaching for Young Patients Using a Hydrogen Peroxide-based Gel: a Randomized, Controlled, Clinical Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of Nove de Julho.