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

NCT01530217 | Completed DMC

• 1 other identifier: 17836/2010
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammation; Pulpitis

Keywords

Analgesics; Ibuprofen; Inflammation; Tooth Bleaching

Outcome Measures

Primary Outcomes (1)

• Tooth sensitivity evaluation

  Patients will be distributed in two groups: Group 1 - Control Group will receive placebo. Group 2 - Ibuprofen will receive not selective anti-inflammatory (Ibuprofen 400 mg). All of the drugs will be administered one hour before the bleaching treatment. Evaluation of Dental Sensitivity Level: the effect of the product will be evaluated up to 1 Hour, 24 and 48 hours after the tooth bleaching, using a verbal scale of 5 points and a Visual Analogue Scale (VAS) will be used.

  Sensitivity during the treatment and until 48 hours after bleaching. The tooth sensitivity will be evaluated only this period because the literature appoint dates in this time.

Secondary Outcomes (1)

• Shade evaluation

  Shade evaluation was recorded before and 30 days after the bleaching treatment.

Interventions

Ibuprofen. DRUG

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.

Also known as: Uniprofen / National Pharmaceutical Chemistry União S / A.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Estadual de Ponta Grossa: lead
• Fundação Araucária: collaborator

MeSH Terms

Conditions

Inflammation; Pulpitis

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Alessandra Reis, doctor

  Universidade Estadual de Ponta Grossa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor. Adjunctive Professors. School of Dentistry. State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: February 9, 2012
• Study Start: March 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 9, 2012

Record last verified: 2012-02