Naproxen on Tooth Sensitivity Caused by In-office Bleaching

Study Overview
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Brief Summary
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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.

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

Conditions
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Toothache, Tooth Bleaching

Intervention / Treatment
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* Drug: Naproxen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |