- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01659840
Efficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders (TMD)
August 7, 2012 updated by: Olga Flecha, Federal University of São Paulo
Efficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders - A Double-blind, Randomized, Parallel Clinical Trial
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
116
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minas Gerais
-
Diamantina, Minas Gerais, Brazil, 39100000
- Periodontics Clinic, Department of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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.
|
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.
|
|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
pain points of muscle and articulation
Time Frame: 180 days
|
180 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life
Time Frame: 180 days
|
180 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Olga D Flecha, Professor, Federal University of the Valleys of Jequitinhonha and Mucuri
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
August 6, 2012
First Submitted That Met QC Criteria
August 7, 2012
First Posted (Estimate)
August 8, 2012
Study Record Updates
Last Update Posted (Estimate)
August 8, 2012
Last Update Submitted That Met QC Criteria
August 7, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- senhaodf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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