Naproxen on Tooth Sensitivity Caused by In-office Bleaching

Not Applicable

Completed

• Conditions: Toothache; Tooth Bleaching
• Interventions: Drug: Naproxen

• Registration Number: NCT02463552
• Lead Sponsor: Universidade Federal de Sergipe

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-04
• Primary Completion: 2016-06
• Status Verified: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Naproxen	-
Naproxen	Naproxen	-

Primary Outcome Measures

Name	Time	Method
Risk to Tooth sensitivity - during procedure	During the bleaching procedure	The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe. Score different from 0 will determine presence of sensitivity. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.

Secondary Outcome Measures

Name	Time	Method
Level of tooth sensitivity - during procedure	During the bleaching procedure	The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe.
Risk of tooth sensitivity - after procedure	24 hours after bleaching prcedure	The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe. Score different from 0 will determine presence of sensitivity. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated.
Level of tooth sensitivity - after procedure	24 hours after bleaching prcedure	The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe.

Trial Locations

Locations (1)

Universidade Federal de Sergipe; 🇧🇷 Aracaju, SE, Brazil