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
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
Pulpitis
Tooth Diseases
Stomatognathic Diseases
Pathologic Processes
Dental Pulp Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014