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

Temporomandibular Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936338
• Other study ID #: 191
• Status: Completed
• Phase: N/A
• First received: July 9, 2009
• Last updated: July 9, 2009
• Start date: January 2006
• Est. completion date: December 2006

Study information

• Verified date: July 2009
• Source: Tokyo Medical and Dental University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2006
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Herniated Disk
• Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Behavioral:
• splint and joint mobilization self exercise

Locations

Country	Name	City	State
Japan	TMJ Clinic, Tokyo Medical and Dental University	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo Medical and Dental University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and (iv) limitation of daily activities		0, 4 and 8 week	No