Naproxen on Tooth Sensitivity Caused by In-office Bleaching

Tooth Bleaching Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02463552
• Other study ID #: UFSergipe
• Status: Completed
• Phase: N/A
• First received: May 29, 2015
• Last updated: October 24, 2016
• Start date: May 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Universidade Federal de Sergipe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dentin Sensitivity
• Tooth Bleaching
• Toothache

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sergipe	Aracaju	SE

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Sergipe

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes