NCT01417650

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

August 16, 2011

Status Verified

June 1, 2010

Enrollment Period

9 months

First QC Date

August 8, 2011

Last Update Submit

August 15, 2011

Conditions

Keywords

temporomandibular disorderlaser therapyosteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Pain relief

    Pain is assessed by visual analogue scale (VAS)

    Up to 1 month after laser theray

Secondary Outcomes (2)

  • TMD sounds

    Up to 1 month after laser therapy

  • Mouth opening measurement

    Up to 1 month after laser therapy

Study Arms (2)

laser

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: low power laser, laser therapy, diode laser
laser

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Temporomandibular Joint DisordersOsteoarthritis

Interventions

Low-Level Light TherapyLaser TherapyLasers, Semiconductor

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesArthritisRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPhototherapyAblation TechniquesSurgical Procedures, OperativeLasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Farzaneh Ahrari, DDS, MS

    Mashhad University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2011

First Posted

August 16, 2011

Study Start

January 1, 2011

Primary Completion

October 1, 2011

Study Completion

January 1, 2012

Last Updated

August 16, 2011

Record last verified: 2010-06