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

NCT00936338 | Completed

• 1 other identifier: 191
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

anterior disc displacement without reduction of temporomandibular disorders

Outcome Measures

Primary Outcomes (1)

• (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

Study Arms (2)

splint

ACTIVE COMPARATOR

Behavioral: splint and joint mobilization self exercise

joint mobilization self exercise

ACTIVE COMPARATOR

Behavioral: splint and joint mobilization self exercise

Interventions

splint and joint mobilization self exercise BEHAVIORAL

joint mobilization self exercise; splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Tokyo Medical and Dental University: lead

Study Sites (1)

TMJ Clinic, Tokyo Medical and Dental University

Tokyo, Japan

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Temporomandibular Joint Disorders

Interventions

Splints

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 10, 2009
• Study Start: January 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 10, 2009

Record last verified: 2009-07

Locations

JP (1)