Overview

This trial has been completed.

Conditions toothache, tooth bleaching
Treatment naproxen
Sponsor Universidade Federal de Sergipe
Start date May 2015
End date June 2016
Trial size 50 participants
Trial identifier NCT02463552, UFSergipe

Summary

This study aims to evaluate the effects of prior use of non-steroidal anti-inflammatory Naproxen on risk and level of tooth sensitivity caused by in-office bleaching procedures.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
naproxen
The patient will receive a single-dose of Naproxen (500 mg) one hour before the bleaching procedure.
(Experimental)
naproxen
The patient will receive a single-dose of Naproxen (500 mg) one hour before the bleaching procedure.

Primary Outcomes

Measure
Risk to Tooth sensitivity - during procedure
time frame: During the bleaching procedure

Secondary Outcomes

Measure
Level of tooth sensitivity - during procedure
time frame: During the bleaching procedure
Risk of tooth sensitivity - after procedure
time frame: 24 hours after bleaching prcedure
Level of tooth sensitivity - after procedure
time frame: 24 hours after bleaching prcedure

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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 2M2 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 Naproxen; - Non-attendance to any session of evaluation or bleaching.

Additional Information

Official title Rior Use of Naproxen on Tooth Sensitivity Reduction After In-office Bleaching: Randomized Clinical Trial
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Universidade Federal de Sergipe.