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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00936338

First Posted: July 10, 2009

Last Update Posted: July 10, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Tokyo Medical and Dental University

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Temporomandibular Joint Dysfunction

U.S. FDA Resources

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 ]


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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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


ClinicalTrials.gov Identifier:	NCT00936338 History of Changes
Other Study ID Numbers:	191
First Submitted:	July 9, 2009
First Posted:	July 10, 2009
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

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