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

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ClinicalTrials.gov Identifier: NCT00936338
Recruitment Status : Completed
First Posted : July 10, 2009
Last Update Posted : July 10, 2009
Sponsor:
Information provided by:
Tokyo Medical and Dental University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Herniated Disk Temporomandibular Disorders Behavioral: splint and joint mobilization self exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2006
Actual Study Completion Date : December 2006

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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. (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 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 (NCT number): NCT00936338


Locations
Japan
TMJ Clinic, Tokyo Medical and Dental University
Tokyo, Japan
Sponsors and Collaborators
Tokyo Medical and Dental University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00936338     History of Changes
Other Study ID Numbers: 191
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: July 2009

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
Intervertebral Disc Displacement
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
 Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Spinal Diseases
Bone Diseases
Hernia
Pathological Conditions, Anatomical