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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 7 November 2016
Main ID:  NCT02463552
Date of registration: 29/05/2015
Prospective Registration: No
Primary sponsor: Universidade Federal de Sergipe
Public title: Naproxen on Tooth Sensitivity Caused by In-office Bleaching
Scientific title: Rior Use of Naproxen on Tooth Sensitivity Reduction After In-office Bleaching: Randomized Clinical Trial
Date of first enrolment: May 2015
Target sample size: 50
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02463552
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention  
Phase:  N/A
Countries of recruitment
Brazil
Contacts
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Toothache
Tooth Bleaching
Intervention(s)
Drug: Naproxen
Primary Outcome(s)
Risk to Tooth sensitivity - during procedure [Time Frame: During the bleaching procedure]
Secondary Outcome(s)
Level of tooth sensitivity - after procedure [Time Frame: 24 hours after bleaching prcedure]
Risk of tooth sensitivity - after procedure [Time Frame: 24 hours after bleaching prcedure]
Level of tooth sensitivity - during procedure [Time Frame: During the bleaching procedure]
Secondary ID(s)
UFSergipe
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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