Clinical trial NCT01530217: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Pulpitis
Keywords: Analgesics
Ibuprofen
Inflammation
Tooth Bleaching
Lead sponsor: Universidade Estadual de Ponta Grossa
Sponsor class: OTHER
Collaborators: name: Fundação Araucária
First posted: 2012-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Tooth sensitivity evaluation
timeFrame: 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:
measure: Shade evaluation
timeFrame: Shade evaluation was recorded before and 30 days after the bleaching treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Estadual de Ponta Grossa
name: Alessandra Reis, doctor
role: PRINCIPAL_INVESTIGATOR
References: