Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching
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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 |
- 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.
- 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) |
-
Drug: Ibuprofen.
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 |
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.
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| 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 May 16, 2013