Piroxicam-beta-Cyclodextrin on Tooth Sensitivity Caused by In-office Bleaching
Status:
Completed
Trial end date:
2017-05-01
Target enrollment:
Participant gender:
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).