Effect of an Anti-inflammatory on Tooth Sensitivity Caused by Bleaching.

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Universidade Estadual de Ponta Grossa
Fundação Araucária
FGM Produtos Odontológicos
Information provided by (Responsible Party):
Eloisa Andrade de Paula, Universidade Estadual de Ponta Grossa
ClinicalTrials.gov Identifier:
NCT01300780
First received: February 22, 2011
Last updated: November 12, 2011
Last verified: November 2011
  Purpose

Perhaps the use of a more selective anti-inflammatory drug, capable of inhibiting enzyme specific for pain may be more effective in preventing the tooth sensitivity caused by the inflammatory response produced by in-office bleaching. To the extent of the authors´ knowledge, no study has so far addressed the use of a selective anti-inflammatory drug specific for pain enzyme on tooth sensitivity, being this the aim of the present investigation.


Condition Intervention
Color Changes During Tooth Formation
Drug: Etoricoxib

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Preoperative Use of an Anti-inflammatory on Tooth Sensitivity Caused by In-office Bleaching: a Randomized, Double-blind Clinical Trial.

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

Primary Outcome Measures:
  • Sensibility [ Time Frame: Evaluation of sensibility during the tooth whitening and 24/48 after of the bleaching ] [ Designated as safety issue: No ]
    The effect of the product will be evaluated immediately, 1 Hour, 24 and 48 hours after the teeth bleaching applied to the patients, using a verbal scale of 5 points, also a numerical scale of 101 points will be used, In addition to these two scales a Visual Analogue Scale (VAS, which consists of 10 cm line. One of the extremes presents a "no pain" indication and the other "unbearable pain". Each patient will be directed to mark with a single vertical dash the point that better matches his pain rating at the moment of the evaluation.


Secondary Outcome Measures:
  • Colour [ Time Frame: In the first session and second session of the tooth whitening ] [ Designated as safety issue: No ]
    For a color rating before, immediately and 30 days after the bleaching treatment the spectrophotometer Vita Easy Shade will be used together with the Vita Classica scale, which will be organized from the highest value (B1) to the lowest (C4). To evaluate color with the spectrophotometer, first a mold will be made of the upper anterior teeth from canine to canine with heavy condensation silicone, which will serve as a guide to the spectrophotometer. A Window of 3 mm in diameter will be made on the vestibular face of the silicon guide in the area of the tooth where the color will be assessed.


Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sensibility
To determine the effect pre operative of anti-inflammatory eotricoxib in the reduction of tooth sensitivity caused by in-office bleaching of vital teeth using hydrogen peroxide 35% and verify effectiveness of color change caused by that product.
Drug: Etoricoxib
Group 1 - Control Group will receive two doses of placebo tablet administered a every 8 hours, Group 2 - experimental Etoricoxib will receive two doses of selective anti-inflammatory to enzyme cyclooxygenase 2 (COX-2) (Etoricoxib 60 mg) given once every 24 hours;
Other Name: Anti-inflamatory

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • will be included patients 18 years old and over
  • with good general and oral health
  • with the eight upper front teeth free of cavities and restorations in the buccal cavity

The initial color of those teeth must be C2 or dark, comparing with scale Vita Lumin (Vita Zahnfabrik, Bad Säckingen, Germany) organized in order of value.

Exclusion Criteria:

  • shall be excluded patients who underwent any previous form of bleaching procedure
  • lactating and pregnant patients
  • who relates sensitivity
  • severe dental browning (tetracycline staining, fluorosis or endodontics)
  • with parafunctional habit or any other type of oral disease

Still will be excluded patients who have systemic conditions as stomach problems, heart, kidney and liver, or using any continuous drug with anti-inflammatory and antioxidant action.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01300780

Locations
Brazil
Universidade Estadual de Ponta Grossa
Guarapuava, Paraná, Brazil, 84030900
Sponsors and Collaborators
Eloisa Andrade de Paula
Universidade Estadual de Ponta Grossa
Fundação Araucária
FGM Produtos Odontológicos
Investigators
Principal Investigator: Alessandra Reis, doctor Universidade Estadual de Ponta Grossa
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eloisa Andrade de Paula, Doctor, Universidade Estadual de Ponta Grossa
ClinicalTrials.gov Identifier: NCT01300780     History of Changes
Other Study ID Numbers: 17838/2010
Study First Received: February 22, 2011
Last Updated: November 12, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Estadual de Ponta Grossa:
bleaching agent
tooth bleaching
sensibility

Additional relevant MeSH terms:
Dentin Sensitivity
Tooth Diseases
Stomatognathic Diseases
Etoricoxib
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 26, 2014