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Efficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders (TMD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Olga Flecha, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01659840
First received: August 6, 2012
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

The study hypothesis was that the red (600nm) and infrared (800nm) laser therapy have the same efficacy in relieving pain and improving the quality of life of TMD patients


Condition Intervention
Temporomandibular Disorders
 Radiation: Red laser
Radiation: Infrared laser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders - A Double-blind, Randomized, Parallel Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • pain points of muscle and articulation [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

Enrollment: 116
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Red laser
On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications.
 Radiation: Red laser
On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications.
Infrared laser
On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications.
 Radiation: Infrared laser
On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications.

Detailed Description:

The aim of the present study was to evaluate and compare the efficacy of red (600nm) and infrared (800nm) laser therapy in relieving pain and improving the quality of life of TMD patients.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • systemic health;
  • Temporomandibular Disorder diagnosed by the Research Diagnostic Criteria for Temporomandibular Disorders questionnaire (RDC);
  • pain score ≥ 5 on palpation according to a visual and numerical scale (VNS)

Exclusion Criteria:

  • participants who made frequent use of analgesics, NSAIDs and antidepressants;
  • patients with previously undergone TMD treatment, or suffered facial trauma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659840

Locations
Brazil
Periodontics Clinic, Department of Dentistry
Diamantina, Minas Gerais, Brazil, 39100000
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Olga D Flecha, Professor Federal University of the Valleys of Jequitinhonha and Mucuri
  More Information

No publications provided

Responsible Party: Olga Flecha, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01659840     History of Changes
Other Study ID Numbers: senhaodf
Study First Received: August 6, 2012
Last Updated: August 7, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
laser,
quality of life,
orofacial pain

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
 Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes

ClinicalTrials.gov processed this record on May 21, 2013