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Naproxen on Tooth Sensitivity Caused by In-office Bleaching

NCT ID: NCT02463552

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-10-31

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.

Detailed Description

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Conditions

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Toothache Tooth Bleaching

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Naproxen

Intervention Type DRUG

The patient will receive a single-dose of Naproxen (500 mg) one hour before the bleaching procedure.

Naproxen

Group Type EXPERIMENTAL

Naproxen

Intervention Type DRUG

The patient will receive a single-dose of Naproxen (500 mg) one hour before the bleaching procedure.

Interventions

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Naproxen

The patient will receive a single-dose of Naproxen (500 mg) one hour before the bleaching procedure.

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal de Sergipe

OTHER

Sponsor Role lead

Responsible Party

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André Luis Faria e Silva

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidade Federal de Sergipe

Aracaju, Sergipe, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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UFSergipe

Identifier Type: -

Identifier Source: org_study_id