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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
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorder focused on measuring temporomandibular disorder, laser therapy, osteoarthritis

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    August 8, 2011
    Last Updated
    August 15, 2011
    Sponsor
    Mashhad University of Medical Sciences
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    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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