The Effect of Low Level Laser Therapy on Improvement of Temporomandibular Joint Osteoarthritis

August 15, 2011 updated by: Mashhad University of Medical Sciences

A Randomized Clinical Trial of the Effect of Low Level Laser Therapy on Improvement of Temporomandibular Joint Osteoarthritis

Temporomandibular disorder (TMD) is the major cause of nondental pain in orofacial area. Laser therapy can be considered as one of the most popular methods of pain relief in TMD patients. The special features of laser light such as coherence, monochromaticity, and collimation can result in the ability of laser light to modify cellular metabolism, increase tissue repair and reduce edema and inflammation. The effectiveness of low level laser therapy in reducing the signs and symptoms of temporomandibular joint disorders has been investigated in a few studies. But, in most of the previous studies the etiology of TMD has not been considered in patient selection. Furthermore, there are some controversies in the results of these studies. According to our data, there is no study evaluating the effects of low level laser therapy on patients having TMJ osteoarthritis.

The aim of this study is to evaluate the effectiveness of low level laser therapy in improving osteoarthritis of temporomandibular joint and also to evaluate the long term effects of laser therapy on the morphology of the joint.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Project method: This study will be implemented on 20 patients aged 35-60 years referring to Department of Prosthetic Dentistry of Mashhad Dental School. The patients are selected according to the RDC/TMD criteria to include those having temporomandibular osteoarthritis with unknown etiology. The patients will be asked to take cone beam CT of temporomandibular joint to evaluate any changes in morphology of the TMJ. The patients will be randomly assigned to two groups: Group 1 (treatment group) will receive low level laser therapy. The laser light will be applied with 890 nm diode laser (Mustang 2000+, Russia) with frequency of 1500 Hz, and dose of 2 J/cm2 per point in the joint area and painful muscles if any. In Group 2 (placebo) the low power laser will be applied with a minimal dose that is very lower than the threshold necessary for therapeutic effects. Laser therapy for both the treatment and placebo groups will be applied in the back, front, and above the mandibular condyles and inside the external auditory meatus and also on painful muscles three times a week for four weeks. Patients will be evaluated at the start of the treatment, after the 6th and 12th sessions of laser therapy and also one month after the end of the treatment. At each evaluation, the pain level in opening the mouth and masticatory muscle tenderness will be measured according to the Visual Analogue Scale (VAS). The range of lateral and protrusive mandibular movements, the difficulty in chewing food and the the presence or absence of sound joints will also be evaluated. One year after treatment, the patients will be referred for taking the second cone beam CT of the TMJ to seek any change in morphology of the joint.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

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

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients are selected according to the RDC/TMD criteria to include those having temporomandibular osteoarthritis with unknown etiology.

Exclusion Criteria:

  1. Patients with systemic problems.
  2. Patients using analgesic or antidepressant drugs.
  3. Patients undergoing any treatment modality for TMD disease.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: laser
In this group, the 890 nm diode laser (Mustang 2000+,Russia) will be used with frequency of 1500 Hz, and dose of 2 J/cm2 per point in the joint area and painful muscles if any.
Radiation: Low level laser therapy
In this group, the 890 nm diode laser (Mustang 2000+, Russia) will be applied with frequency of 1500 Hz, and dose of 2 J/cm2 per point in the joint area and painful muscles if any.
Other Names:
  • low power laser, laser therapy, diode laser
Radiation: Low level laser therapy
In this group, the low level laser will be applied with a minimal dose that is very lower than the threshold necessary for therapeutic effects.
Other Names:
  • low power laser, laser therapy, diode laser
Placebo Comparator: placebo
In this group the low power laser will be applied with minimal dose that is very lower than the threshold necessary for therapeutic effects.
Radiation: Low level laser therapy
In this group, the 890 nm diode laser (Mustang 2000+, Russia) will be applied with frequency of 1500 Hz, and dose of 2 J/cm2 per point in the joint area and painful muscles if any.
Other Names:
  • low power laser, laser therapy, diode laser
Radiation: Low level laser therapy
In this group, the low level laser will be applied with a minimal dose that is very lower than the threshold necessary for therapeutic effects.
Other Names:
  • low power laser, laser therapy, diode laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief
Time Frame: Up to 1 month after laser theray
Pain is assessed by visual analogue scale (VAS)
Up to 1 month after laser theray

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TMD sounds
Time Frame: Up to 1 month after laser therapy
The presence or absence of articular sounds is checked.
Up to 1 month after laser therapy
Mouth opening measurement
Time Frame: Up to 1 month after laser therapy
The amount of mouth opening with and without pain is measured.
Up to 1 month after laser therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

  • Principal Investigator: Farzaneh Ahrari, DDS, MS, Mashhad University of Medical Sciences

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

January 1, 2011

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

August 8, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (Estimate)

August 16, 2011

Study Record Updates

Last Update Posted (Estimate)

August 16, 2011

Last Update Submitted That Met QC Criteria

August 15, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 89342

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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