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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Mashhad University of Medical Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01417650
First received: August 8, 2011
Last updated: August 15, 2011
Last verified: June 2010
  Purpose

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.


Condition Intervention
Temporomandibular Joint Disorder
Radiation: Low level laser therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of the Effect of Low Level Laser Therapy on Improvement of Temporomandibular Joint Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • Pain relief [ Time Frame: Up to 1 month after laser theray ] [ Designated as safety issue: No ]
    Pain is assessed by visual analogue scale (VAS)


Secondary Outcome Measures:
  • TMD sounds [ Time Frame: Up to 1 month after laser therapy ] [ Designated as safety issue: No ]
    The presence or absence of articular sounds is checked.

  • Mouth opening measurement [ Time Frame: Up to 1 month after laser therapy ] [ Designated as safety issue: No ]
    The amount of mouth opening with and without pain is measured.


Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 low level laser will be applied with a minimal dose that is very lower than the threshold necessary for therapeutic effects.
Other Name: low power laser, laser therapy, diode laser

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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417650

Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
Principal Investigator: Farzaneh Ahrari, DDS, MS Mashhad University of Medical Sciences
  More Information

No publications provided

Responsible Party: Azam Madani, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01417650     History of Changes
Other Study ID Numbers: 89342
Study First Received: August 8, 2011
Last Updated: August 15, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Mashhad University of Medical Sciences:
temporomandibular disorder
laser therapy
osteoarthritis

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

ClinicalTrials.gov processed this record on October 21, 2014