Randomized Clinical Trial of Treatment for Temporomandibular Joint (TMJ) Disc Displacement
Primary Purpose
Herniated Disk, Temporomandibular Disorders
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
splint and joint mobilization self exercise
Sponsored by
About this trial
This is an interventional treatment trial for Herniated Disk focused on measuring anterior disc displacement without reduction of temporomandibular disorders
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.
Sites / Locations
- TMJ Clinic, Tokyo Medical and Dental University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
splint
joint mobilization self exercise
Arm Description
Outcomes
Primary Outcome Measures
(i) maximum mouth opening range without and (ii) with pain, (iii) present pain intensity, and (iv) limitation of daily activities
Secondary Outcome Measures
Full Information
NCT ID
NCT00936338
First Posted
July 9, 2009
Last Updated
July 9, 2009
Sponsor
Tokyo Medical and Dental University
1. Study Identification
Unique Protocol Identification Number
NCT00936338
Brief Title
Randomized Clinical Trial of Treatment for Temporomandibular Joint (TMJ) Disc Displacement
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tokyo Medical and Dental University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herniated Disk, Temporomandibular Disorders
Keywords
anterior disc displacement without reduction of temporomandibular disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
splint
Arm Type
Active Comparator
Arm Title
joint mobilization self exercise
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
splint and joint mobilization self exercise
Primary Outcome Measure Information:
Title
(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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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.
Facility Information:
Facility Name
TMJ Clinic, Tokyo Medical and Dental University
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Randomized Clinical Trial of Treatment for Temporomandibular Joint (TMJ) Disc Displacement
We'll reach out to this number within 24 hrs