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

NCT ID: NCT00936338

Last Updated: 2009-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2006-12-31

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.

Conditions

Herniated Disk; Temporomandibular Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

splint

Group Type: ACTIVE_COMPARATOR

splint and joint mobilization self exercise

Intervention Type: BEHAVIORAL

joint mobilization self exercise

Group Type: ACTIVE_COMPARATOR

splint and joint mobilization self exercise

Intervention Type: BEHAVIORAL

Interventions

splint and joint mobilization self exercise

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokyo Medical and Dental University

OTHER

Sponsor Role: lead

Locations

TMJ Clinic, Tokyo Medical and Dental University

Tokyo, , Japan

Countries

Japan

Other Identifiers

191

Identifier Type: -

Identifier Source: org_study_id