Back to resultsEfficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders (TMD)
Primary Purpose
Temporomandibular Disorders
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Red laser
Infrared laser
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorders focused on measuring laser,, quality of life,, orofacial pain
Eligibility 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
Sites / Locations
- Periodontics Clinic, Department of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Red laser
Infrared laser
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
pain points of muscle and articulation
Secondary Outcome Measures
Quality of life
Full Information
NCT ID
NCT01659840
First Posted
August 6, 2012
Last Updated
August 7, 2012
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01659840
Brief Title
Efficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders
Acronym
TMD
Official Title
Efficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders - A Double-blind, Randomized, Parallel Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders
Keywords
laser,, quality of life,, orofacial pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Red laser
Arm Type
Other
Arm Description
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.
Arm Title
Infrared laser
Arm Type
Other
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Red laser
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Infrared laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain points of muscle and articulation
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga D Flecha, Professor
Organizational Affiliation
Federal University of the Valleys of Jequitinhonha and Mucuri
Official's Role
Principal Investigator
Facility Information:
Facility Name
Periodontics Clinic, Department of Dentistry
City
Diamantina
State/Province
Minas Gerais
ZIP/Postal Code
39100000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders
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