NCT02935114

IN-OFFICE TOOTH BLEACHING WITH 37% CARBAMIDE PEROXIDE

EVALUATION OF CLINICAL EFFICACY AND SENSIBILITY OF BLEACHING AGENT 37% CARBAMIDE PEROXIDE IN-OFFICE TOOTH BLEACHING: CLINICAL TRIAL RANDOMIZED CONTROLLED
Universidade Federal de Sergipe·Phase 3·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov
Study focus
Disease/Condition
Tooth Sensitivity
Drug/Device/Intervention
37% Carbamide Peroxide
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Universidade Federal de Sergipe
Timeline & enrollment
Phase
Phase 3
Start date
May 01, 2016
End date
Nov 01, 2016
Enrollment
50 participants
Primary outcome

Color evaluation

Summary

Objectives: This study will determine the clinical efficacy of bleaching agent 37% carbamide
 peroxide compared to 35% hydrogen peroxide on the change of color scores in anterior superior
 teeth, in-office bleaching technique after 7, 14 and 37 days; and the Risk to the tooth
 sensitivity before, during and 24 hours after the procedure.
 
 Materials and Methods: Fifty patients will be selected for this single-blind, parallel,
 randomized-controlled clinical trial. The whitening treatment with 37% carbamide peroxide or
 35% hydrogen peroxide (control) will be carried out in a single application of 45 minutes for
 two sessions with a 7-day interval. The sensitivity level will be assessed before, during and
 24 hours after the procedure using verbal and analogic visual analogue (VAS) scales. Color
 alteration will be assessed by a bleach guide scale 7 days after each session and 30 days
 after the last session. Relative risk to sensitivity will be calculated and adjusted by
 session; while comparison of overall risk will performed by McNemar's test. Data on the
 sensitivity level for both scales will be subjected to the Mann-Whitney tests (α = 0.05). The
 color change will be measured with a spectrophotometer using the CIE L * a * b * and the L*,
 a * and b * parameter delta data, and ΔE and Δ00, will be individually subjected to two-way
 repeated measures ANOVA test to compare the two bleaching techniques at each evaluation time
 (α = 0.05).

ICD-10 classifications
Anomalies of tooth positionTeething syndromeDisturbances in tooth eruptionDisturbances in tooth formationOther disorders of tooth development
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT02935114
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT02935114 through Pure Global AI's free database. This Phase 3 trial is sponsored by Universidade Federal de Sergipe and is currently Completed. The study focuses on Tooth Sensitivity. Target enrollment is 50 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.