Back to resultsAssessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching
Primary Purpose
Inflammation, Pulpitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ibuprofen.
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation focused on measuring Analgesics, Ibuprofen, Inflammation, Tooth Bleaching
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.
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Shade evaluation
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).
Full Information
NCT ID
NCT01530217
First Posted
December 13, 2011
Last Updated
February 8, 2012
Sponsor
Universidade Estadual de Ponta Grossa
Collaborators
Fundação Araucária
1. Study Identification
Unique Protocol Identification Number
NCT01530217
Brief Title
Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching
Official Title
Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching: a Randomized, Triple-blind Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual de Ponta Grossa
Collaborators
Fundação Araucária
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Pulpitis
Keywords
Analgesics, Ibuprofen, Inflammation, Tooth Bleaching
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ibuprofen.
Other Intervention Name(s)
Uniprofen / National Pharmaceutical Chemistry União S / A.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tooth sensitivity evaluation
Description
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.
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.
Secondary Outcome Measure Information:
Title
Shade evaluation
Description
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).
Time Frame
Shade evaluation was recorded before and 30 days after the bleaching treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandra Reis, doctor
Organizational Affiliation
Universidade Estadual de Ponta Grossa
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching
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