Naproxen on Tooth Sensitivity Caused by In-office Bleaching

Rior Use of Naproxen on Tooth Sensitivity Reduction After In-office Bleaching: Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Tooth Bleaching; Toothache
• Intervention / Treatment: Drug: Naproxen

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SE
    • Aracaju, SE, Brazil, 49060100
      • Universidade Federal de Sergipe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Naproxen; The patient will receive a single-dose of Naproxen (500 mg) one hour before the bleaching procedure.
Experimental: Naproxen	Drug: Naproxen; The patient will receive a single-dose of Naproxen (500 mg) one hour before the bleaching procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk to Tooth sensitivity - during 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.	During the bleaching procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of tooth sensitivity - during 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.	During the bleaching procedure
Risk of tooth sensitivity - after 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.	24 hours after bleaching prcedure
Level of tooth sensitivity - after 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.	24 hours after bleaching prcedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of bleaching	A spectrophotometer will be used to assess the color alteration, while the parameter "L", "a" and "b" will be recorded.	7 days after bleaching procedure

Collaborators and Investigators

• Sponsor: Universidade Federal de Sergipe

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Dentin Sensitivity; Toothache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: UFSergipe