The Effect of Low Level Laser Therapy on Improvement of Temporomandibular Joint Osteoarthritis
Primary Purpose
Temporomandibular Joint Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low level laser therapy
Low level laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Joint Disorder focused on measuring temporomandibular disorder, laser therapy, osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- The patients are selected according to the RDC/TMD criteria to include those having temporomandibular osteoarthritis with unknown etiology.
Exclusion Criteria:
- Patients with systemic problems.
- Patients using analgesic or antidepressant drugs.
- Patients undergoing any treatment modality for TMD disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
laser
placebo
Arm Description
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.
In this group the low power laser will be applied with minimal dose that is very lower than the threshold necessary for therapeutic effects.
Outcomes
Primary Outcome Measures
Pain relief
Pain is assessed by visual analogue scale (VAS)
Secondary Outcome Measures
TMD sounds
The presence or absence of articular sounds is checked.
Mouth opening measurement
The amount of mouth opening with and without pain is measured.
Full Information
NCT ID
NCT01417650
First Posted
August 8, 2011
Last Updated
August 15, 2011
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01417650
Brief Title
The Effect of Low Level Laser Therapy on Improvement of Temporomandibular Joint Osteoarthritis
Official Title
A Randomized Clinical Trial of the Effect of Low Level Laser Therapy on Improvement of Temporomandibular Joint Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorder
Keywords
temporomandibular disorder, laser therapy, osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laser
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
In this group the low power laser will be applied with minimal dose that is very lower than the threshold necessary for therapeutic effects.
Intervention Type
Radiation
Intervention Name(s)
Low level laser therapy
Other Intervention Name(s)
low power laser, laser therapy, diode laser
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Low level laser therapy
Other Intervention Name(s)
low power laser, laser therapy, diode laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain relief
Description
Pain is assessed by visual analogue scale (VAS)
Time Frame
Up to 1 month after laser theray
Secondary Outcome Measure Information:
Title
TMD sounds
Description
The presence or absence of articular sounds is checked.
Time Frame
Up to 1 month after laser therapy
Title
Mouth opening measurement
Description
The amount of mouth opening with and without pain is measured.
Time Frame
Up to 1 month after laser therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients are selected according to the RDC/TMD criteria to include those having temporomandibular osteoarthritis with unknown etiology.
Exclusion Criteria:
Patients with systemic problems.
Patients using analgesic or antidepressant drugs.
Patients undergoing any treatment modality for TMD disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farzaneh Ahrari, DDS, MS
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Effect of Low Level Laser Therapy on Improvement of Temporomandibular Joint Osteoarthritis
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