Etodolac and Post-bleaching Sensitivity

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives: This study will determine the effectiveness of preemptive administration of etodolac on risk and intensity of tooth sensitivity caused by in-office bleaching using 35% hydrogen peroxide.

Materials and Methods: Fifty patients will be selected for this triple-blind, randomized, cross-over, placebo-controlled clinical trial. Etodolac (400 mg) or placebo will be administrated in a single-dose 1 hour prior to bleaching procedure. The whitening treatment with 35% hydrogen peroxide will be carried out in two sessions with a 7-day interval. Tooth sensitivity will be assessed before, during and 24 hours after the procedure using analog visual and verbal scales. Color alteration will be assessed by a bleach guide scale 7 days after each 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 and color shade will be subjected to the Friedman, Wilcoxon and Mann-Whitney tests, respectively (α = 0.05).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Flavia Pardo Salata Nahsan
• Treatments: Etodolac

Criteria

Inclusion Criteria:

• Patients included in this clinical trial will be at least 18 years old with good oral health. . Only patients presenting all six upper anterior teeth with shade mismatching with 2.5 M2 (Vita Bleachguide 3D-Master scale, Vita-Zahnfabrik, Bad Sackingen, Germany) or darker will be included.

Exclusion Criteria:

• Patients with any of the six upper anterior teeth with caries, restoration, severe discoloration (e.g., stains caused by tetracycline), enamel hypoplasia, gingival recession, dentin exposure, pulpitis, or endodontics will be excluded. Participants submitted to previous bleaching procedures, presenting prior tooth sensitivity, known allergy to any component of medication used in the study, pregnant or breastfeeding will be also excluded.