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

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidade Federal de Sergipe
• Treatments: Betadex; Piroxicam; Piroxicam-beta-cyclodextrin

Criteria

Inclusion Criteria:

• At least 18 years old patients of both genders presenting good general/oral health;

• All maxillary anterior teeth presenting shade equal or darker than 2,5M2 at Vita bleachguide guide (Vita-Zahnfabrik, Germany);

• Signed the form accepting to participate of this study.

Exclusion Criteria:

• Presence of caries lesions, restorations and/or endodontic treatment at any maxillary anterior teeth.

• Undergone tooth-whitening procedures;

• Pregnant/lactating;

• Presence of periodontal diseases;

• Presence of severe tooth discoloration by tetracycline stains or fluorosis;

• Any kind of medicine, bruxism habits or any other pathology that can cause sensitivity (such as recession, dentin exposure);

• Continuous use of drugs with anti-inflammatory actions;

• Presence of tooth hypersensitivity at baseline measurement;

• Any known adverse effects caused by Piroxicam-beta-Cyclodextrin;

• Non-attendance to any session of evaluation or bleaching.