drugset / Trial / NCT03153657

Piroxicam-beta-Cyclodextrin on Tooth Sensitivity Caused by In-office Bleaching

NCT03153657

Phase 3 Completed 50 enrolled Federal University of Sergipe
RandomizedCrossoverTriple-blindPrevention

Summary

Objectives: This study aims to evaluate the effectiveness of preemptive administration of non-steroidal anti-inflammatory Piroxicam-beta-Cyclodextrin on risk and level of tooth sensitivity caused by in-office bleaching procedures using 35% hydrogen peroxide. Fifty patients will be selected for this triple-blind, randomized, cross-over, placebo-controlled clinical trial. Piroxicam-beta-Cyclodextrin (200 mg) or placebo will be administrated in a single-dose thirty minutes 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 Immediately before bleaching agent removal and up to 24 hours after each session 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 Fisher's exact test. Data on the sensitivity level for both scales and color shade will be subjected to the Mann-Whitney and Friedman tests, respectively (α = 0.05).

Timeline

Start
2016-12-13
Primary completion
2017-04
Completion
2017-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Piroxicam Unknown 20 mg