Naproxen on Tooth Sensitivity Caused by In-office Bleaching

NCT02463552 | Completed

• 1 other identifier: UFSergipe
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Toothache; Tooth Bleaching

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Level of tooth sensitivity - during procedure

  During the bleaching procedure

• Risk of tooth sensitivity - after procedure

  24 hours after bleaching prcedure

• Level of tooth sensitivity - after procedure

  24 hours after bleaching prcedure

Other Outcomes (1)

• Efficacy of bleaching

  7 days after bleaching procedure

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Naproxen

Naproxen

EXPERIMENTAL

Drug: Naproxen

Interventions

Naproxen DRUG

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

Naproxen; Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sergipe: lead

Study Sites (1)

Universidade Federal de Sergipe

Aracaju, Sergipe, 49060100, Brazil

Location

MeSH Terms

Conditions

Toothache

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 4, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

BR (1)