Safety and Efficacy of a 6% Hydrogen Peroxide Tooth Bleaching Agent

NCT02353611 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-11-22

No results posted yet for this study

Summary

Bleaching protocol In each session, volunteers received prophylaxis with pumice powder and water. Then, gingival tissue was protected using a light-cured resin gum barrier applied according to the manufacturer's instructions (Lase Protect - DMC, São Carlos, SP, Brazil). Both bleaching agents were prepared by mixing hydrogen peroxide and thickening compounds according to the manufacturer's instructions (with 3 peroxide drops for 1 drop of thickener). The resultant gels were distributed uniformly on the upper hemiarcade surfaces of the teeth. A total of 8 teeth between the first premolars were bleached for each patient. In each bleaching session, the bleaching gels were applied twice for 12 minutes each. In each application, the surface of the gel was light activated with continuous irradiance for 12 minutes using LED/laser light with a total power of 1800 mW (Whitening Lase Plus - DMC Equipamentos, São Carlos, SP, Brazil). Three bleaching sessions were completed for the patients, and the interval between sessions was 7 days

Conditions

  • Tooth Bleaching

Interventions

OTHER

6% hydrogen peroxide

OTHER

35% hydrogen peroxide

conventional peroxide whitening compound acted like control

Sponsors & Collaborators

  • University of Chile

    lead OTHER

Principal Investigators

  • Javier Martín · University of Chile

  • Eduardo Fernandez · University of Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

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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 NCT02353611 on ClinicalTrials.gov