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

This study has been completed.
Sponsor:
Information provided by:
Tokyo Medical and Dental University
ClinicalTrials.gov Identifier:
NCT00936338
First received: July 9, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Herniated Disk
Temporomandibular Disorders
Behavioral: splint and joint mobilization self exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Tokyo Medical and Dental University:

Primary Outcome Measures:
  • (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 ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2006
Study Completion Date: December 2006
Arms Assigned Interventions
Active Comparator: splint Behavioral: splint and joint mobilization self exercise
Active Comparator: joint mobilization self exercise Behavioral: splint and joint mobilization self exercise

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00936338

Locations
Japan
TMJ Clinic, Tokyo Medical and Dental University
Tokyo, Japan
Sponsors and Collaborators
Tokyo Medical and Dental University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00936338     History of Changes
Other Study ID Numbers: 191
Study First Received: July 9, 2009
Last Updated: July 9, 2009
Health Authority: Japan: Institutional Review Board

Keywords provided by Tokyo Medical and Dental University:
anterior disc displacement without reduction of temporomandibular disorders

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

ClinicalTrials.gov processed this record on October 20, 2014