Randomized Clinical Trial of Treatment for Temporomandibular Joint (TMJ) Disc Displacement - Full Text View

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:

MedlinePlus related topics: Exercise and Physical Fitness 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 ] [ 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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:


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

ClinicalTrials.gov processed this record on September 29, 2016