NCT03089216

Combined Bleaching Technique: Efficacy and Tooth Sensitivity

Combined Bleaching Technique: Efficacy and Tooth Sensitivity - A Randomized, Double Blind Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Terezinha de Jesus Esteves Barata · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The aim of this clinical study is to evaluate the efficacy and dental sensitivity associated with Combined Bleaching Technique (in-office + at-home) varying in-office bleaching application under two different time protocols, and dentifrice containing arginine 8% and carbonate calcium use. One hundred eight participants who meet the study inclusion criteria will be selected. The desensitizing agent used will be a dentifrice containing 8% arginine and calcium carbonate. In each evaluation will be determined: tooth sensitivity and color. The data collected will be submitted to the factorial statistical analysis for evaluation of color and chi-square test for tooth sensitivity (α = 5%).

Detailed description

This study will be conducted under the CONSORT recommendations. After approval by the Ethics Committee for Research duly registered, the trial will be conducted in the clinic of dental school at the Federal University of Goias located in Goiania. One hundred eight participants 108 volunteers will be selected on the criteria that qualify inclusion and exclusion from the study will be reported all volunteers were examined not qualify under the criteria for inclusion as part of the initial according to CONSORT recommendations . After signing the signed an informed consent form all volunteer participants will receive a dental prophylaxis with pumice and water in a rubber cups for the removal of extrinsic stains two weeks before the beginning of tooth whitening.

Conditions

• Tooth Bleaching
• Tooth Sensitivity

Interventions

Type	Name	Description
PROCEDURE	Combined Bleaching(2x20)	one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
PROCEDURE	Combined Bleaching(2x20) with arginine	one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
PROCEDURE	Combined Bleaching (1x20)	one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
PROCEDURE	Combined Bleaching(1x20) with arginine	one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
DRUG	8% arginine and calcium carbonate	using during all the treatment.

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-11-30
• Completion: 2018-12-31
• First posted: 2017-03-24
• Last updated: 2019-08-05
• Results posted: 2019-08-05