Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching

NCT ID: NCT01530217

Last Updated: 2012-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-05-31

Brief Summary

Ibuprofen has been recognized as anti-inflammatory and analgesic. The purpose of this study is to determine the effect of ibuprofen 400 mg on tooth sensitivity (TS) caused by in-office bleaching.

Methods: 30 health adults who received either placebo or ibuprofen. The drugs were administered 1 hour prior to the bleaching and will be prescribed 5 doses every 8 hours during 48 hours. For bleaching will be used 35% hydrogen peroxide gel. The tooth sensitivity will be recorded for up and lower arc on two scales: VAS (visual analogic scale) and 0-4. The shade evaluation will be performed before and 30 days after bleaching with visual shade guide and spectrophotometer.

Detailed Description

Background: Ibuprofen has been recognized as anti-inflammatory and analgesic. The purpose of this study was to determine the effect of ibuprofen 400 mg on tooth sensitivity (TS) caused by in-office bleaching.

Methods: A triple-blind, parallel design, randomized clinical trial will be conducted on 30 health adults who received either placebo or ibuprofen. The drugs will be administered 1 hour prior to the bleaching and a every eight hours during 48 hours. For bleaching used 35% hydrogen peroxide gel. The TS will be recorded for up and lower arc on two scales: VAS and 0-4. The shade evaluation will be performed before and 30 days after bleaching with visual shade guide and spectrophotometer. The % of patients that reported TS at least once during treatment and the TS intensity will be evaluated by Fisher's and Mann-Whitney tests, respectively. The color changes will be evaluated by repeated measures ANOVA.

Conditions

Inflammation; Pulpitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Interventions

Ibuprofen.

Ibuprofen Group will be receive a dose of non-steroidal antiinflammatory drug ibuprofen 400 mg. All the participants will be watched to ensure that they took the drugs 1 hour prior to treatment. A second dose of ibuprofen (400 mg), will be administered a every 8 hours after the first dose during 48 hours.

Intervention Type: DRUG

Other Intervention Names

Uniprofen / National Pharmaceutical Chemistry União S / A.

Eligibility Criteria

Inclusion Criteria

• patients included in this clinical trial were:
• at least 18 years old.
• had good general and oral health.
• the participants should have eight caries-free maxillary and jaw anterior teeth and without restorations on the labial surfaces.
• the central incisors should be shade C2 or darker.

Exclusion Criteria

• participants that had undergone tooth-whitening procedures.
• presenting anterior restorations.
• pregnant/lactating.
• with severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth).
• taking any kind of medicine, bruxism habits or any other pathology that could cause sensitivity (such as recession, dentine exposure).
• participants that reported some earlier or present health problems in stomach, heart, kidney and liver, or participants using any continuous drug with anti-inflammatory and antioxidant action were excluded from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação Araucária

OTHER

Sponsor Role: collaborator

Universidade Estadual de Ponta Grossa

OTHER

Sponsor Role: lead

Responsible Party

Alessandra Reis

Doctor. Adjunctive Professors. School of Dentistry. State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandra Reis, doctor

Role: PRINCIPAL_INVESTIGATOR

Universidade Estadual de Ponta Grossa

Other Identifiers

17836/2010

Identifier Type: -

Identifier Source: org_study_id