CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 108 enrolled
Drug / intervention
8% arginine and calcium carbonate +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03089216
NCT03089216Phase 4Completed

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

Terezinha de Jesus Esteves Barata·interventional·Posted Mar 24, 2017·Updated Aug 5, 2019

In Brief

A Phase 4 clinical trial evaluating Combined Bleaching(2x20), Combined Bleaching(2x20) with arginine, and 3 other interventions for Tooth Bleaching and Tooth Sensitivity. Completed, enrolled 108 participants.

Detailed 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%).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 24, 2017
Enrollment StartApr 1, 2016
Primary CompletionNov 30, 2016
Study CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.3 years ago

Interventions

Combined Bleaching(2x20)procedure

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.

Combined Bleaching(2x20) with arginineprocedure

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.

Combined Bleaching (1x20)procedure

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.

Combined Bleaching(1x20) with arginineprocedure

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.

8% arginine and calcium carbonatedrug

using during all the treatment.