Randomized Clinical Trial of Treatment for Temporomandibular Joint (TMJ) Disc Displacement

July 9, 2009 updated by: Tokyo Medical and Dental University
The effectiveness of physical therapy for treatment of anterior disc displacement without reduction of temporomandibular disorders has not been well defined. This study compared the treatment method with conservative splint therapy. Fifty two subjects were assigned at random to either of two treatment groups: one is a splint treatment group, and the other is a joint mobilization self exercise group. Each treatment was evaluated using four outcome variables: (i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and (iv) limitation of daily activities. All outcome variables were significantly improved after eight-week of treatment in the exercise group. Meanwhile, the splint treatment improved three variables, other than "mouth opening with pain"; however, the degree of improvement was less than that seen in the exercise group. This result demonstrates that the joint mobilization self exercise improves jaw function and relieves pain as compared to the splint treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • TMJ Clinic, Tokyo Medical and Dental University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • (1) male or female over 18 years old;
  • (2) with mouth opening pain on the TMJ affected side;
  • (3) over two weeks after the onset of ADDwoR;
  • (4) with maximum mouth opening of less than 40 mm; and
  • (5) MRI-confirmed ADDwoR. The

Exclusion Criteria:

  • (1) unwilling or unable to receive splint and/or exercise therapy;
  • (2) with systemic bone or joint disease,
  • (3) regular medication such as analgesics, anti-anxiety drugs, antidepressants and psychotropics; and
  • (4) missing teeth and/or a removable denture but having a fixed partial denture restoration over one year.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: splint
Behavioral: splint and joint mobilization self exercise
Active Comparator: joint mobilization self exercise
Behavioral: splint and joint mobilization self exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
(i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and (iv) limitation of daily activities
Time Frame: 0, 4 and 8 week
0, 4 and 8 week

Collaborators and Investigators

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

Sponsor

Tokyo Medical and Dental University

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, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (Estimate)

July 10, 2009

Study Record Updates

Last Update Posted (Estimate)

July 10, 2009

Last Update Submitted That Met QC Criteria

July 9, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191

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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