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

Not Applicable

Completed

• Conditions: Tooth Discoloration
• Interventions: Other: 35% hydrogen peroxide; Other: 20% hydrogen peroxide

• Registration Number: NCT02414464
• Lead Sponsor: University of Nove de Julho

Brief 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.

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2014-09
• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-10
• Study Completion: 2015-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
35% hydrogen peroxide	35% hydrogen peroxide	Volunteers of this group will receive a gel with 35% hydrogen peroxide - Whiteness HP 35% for whitening treatment.
20% hydrogen peroxide with calcium	20% hydrogen peroxide	Volunteers of this group will receive a gel with 35% hydrogen peroxide with calcium - Whiteness HP Blue Calcium 20% for whitening treatment.
35% hydrogen peroxide with calcium	35% hydrogen peroxide	Volunteers of this group will receive a gel with 35% hydrogen peroxide with calcium - Whiteness HP Blue Calcium 35% for whitening treatment.

Primary Outcome Measures

Name	Time	Method
Discoloration	Change of teeth color after 48 hours, after 6 months, after 12 months, after 18 months	the initial tooth color was determined with the aid of the classic Vita® scale. Tooth color was recorded 48 hours after each session to determine the difference in tone before and after the procedures.; It will be carried out in all groups at the following times: pre-treatment period, 48 hours following each session, after six months, after 12 months, after 18 months.

Secondary Outcome Measures

Name	Time	Method
Dental sensitivity	Sensivity alteration up to 48 hours after the procedure	The visual analog scale was used for the subjective measure of sensitivity during and after the procedures.