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

This study has been completed.
Sponsor:
Collaborator:
Fundação Araucária
Information provided by (Responsible Party):
Alessandra Reis, Universidade Estadual de Ponta Grossa
ClinicalTrials.gov Identifier:
NCT01530217
First received: December 13, 2011
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Inflammation
Pulpitis
Drug: Ibuprofen.

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching: a Randomized, Triple-blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by Universidade Estadual de Ponta Grossa:

Primary Outcome Measures:
  • Tooth sensitivity evaluation [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Shade evaluation [ Time Frame: Shade evaluation was recorded before and 30 days after the bleaching treatment. ] [ Designated as safety issue: Yes ]
    Shade evaluation was recorded using two methods: the subjective evaluation using a shade guide (Vita Lumin, Vita Zahnfabrik, Bad Säckingen, Germany) and an objective evaluation using the spectrophotometer (Easyshade, Vident, Brea, CA, USA).


Enrollment: 30
Study Start Date: March 2011
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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.
    Other Name: Uniprofen / National Pharmaceutical Chemistry União S / A.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01530217

Sponsors and Collaborators
Universidade Estadual de Ponta Grossa
Fundação Araucária
Investigators
Principal Investigator: Alessandra Reis, doctor Universidade Estadual de Ponta Grossa
  More Information

No publications provided

Responsible Party: Alessandra Reis, Doctor. Adjunctive Professors. School of Dentistry. State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil., Universidade Estadual de Ponta Grossa
ClinicalTrials.gov Identifier: NCT01530217     History of Changes
Other Study ID Numbers: 17836/2010
Study First Received: December 13, 2011
Last Updated: February 8, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Estadual de Ponta Grossa:
Analgesics
Ibuprofen
Inflammation
Tooth Bleaching

Additional relevant MeSH terms:
Dentin Sensitivity
Inflammation
Pathologic Processes
Stomatognathic Diseases
Tooth Diseases
Ibuprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014