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IN-OFFICE TOOTH BLEACHING WITH 37% CARBAMIDE PEROXIDE

NCT02935114 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-11-15

No results posted yet for this study

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).

Conditions

  • Tooth Sensitivity

Interventions

DRUG

37% Carbamide Peroxide

* no Gingival dam protection (as manufacturer´s instruction) * 37% Carbamide Peroxide application (2 sessions of 45 minutes) * Tooth sensitivity (Verbal and visual scale) and color evaluation

DRUG

35% hydrogen Peroxide

* Gingival dam protection (as manufacturer´s instruction) * 35% Hydrogen Peroxide application (2 sessions of 45 minutes) * Tooth sensitivity (Verbal and visual scale) and color evaluation

Sponsors & Collaborators

  • Universidade Federal de Sergipe

    lead OTHER

Principal Investigators

  • Aline C Peixoto · Universidade Federal de Sergipe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-06-30
Completion
2016-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02935114 on ClinicalTrials.gov