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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01300780
First Posted: February 23, 2011
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Universidade Estadual de Ponta Grossa
Fundação Araucária
Information provided by (Responsible Party):
Eloisa Andrade de Paula, Universidade Estadual de Ponta Grossa
  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 Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Preoperative Use of an Anti-inflammatory on Tooth Sensitivity Caused by In-office Bleaching: A Randomized, Double-blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by Eloisa Andrade de Paula, 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 ]
    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 ]
    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
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Experimental
The participants from the placebo group received a placebo (Talco pharma SM-200-Henrifarma produtos químicos e farmacêuticos LTDA, São Paulo, SP, Brazil) and participants from the etoricoxib group received a dose of a selective COX- 2 inhibitor etoricoxib 60 mg (Arcoxia, MSD, Campinas, SP, Brazil). All the participants were watched to ensure that they took the drugs or placebo 1 h before treatment. The drugs were similar in appearance. A second dose of placebo or etoricoxib (60 mg) was administered 24 h after the first dose. At the time the participants were required to take the second dose of the medicine, the research auxiliary called him/her and asked him/her to take the medicine.
Drug: Etoricoxib
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
Placebo Comparator: placebo group
The participants from the placebo group received a placebo (Talco pharma SM-200-Henrifarma produtos químicos e farmacêuticos LTDA, São Paulo, SP, Brazil) and participants from the etoricoxib group received a dose of a selective COX- 2 inhibitor etoricoxib 60 mg (Arcoxia, MSD, Campinas, SP, Brazil). All the participants were watched to ensure that they took the drugs or placebo 1 h before treatment. The drugs were similar in appearance. A second dose of placebo or etoricoxib (60 mg) was administered 24 h after the first dose. At the time the participants were required to take the second dose of the medicine, the research auxiliary called him/her and asked him/her to take the medicine.
Other: Placebo
Group 1 - Control Group will receive two doses of placebo tablet administered a every 8 hours,
Other Name: Placebo group

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Principal Investigator: Alessandra Reis, doctor Universidade Estadual de Ponta Grossa
  More Information

Publications:
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
First Submitted: February 22, 2011
First Posted: February 23, 2011
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Eloisa Andrade de Paula, Universidade Estadual de Ponta Grossa:
bleaching agent
tooth bleaching
sensibility

Additional relevant MeSH terms:
Dentin Sensitivity
Tooth Diseases
Stomatognathic Diseases
Etoricoxib
Anti-Inflammatory Agents
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
Antirheumatic Agents