Platelet-Rich Plasma vs Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint
Primary Purpose
Degenerative Joint Disease
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Group A (corticosteroid injection group)
Group B (platelet rich plasma injection group)
Sponsored by
About this trial
This is an interventional health services research trial for Degenerative Joint Disease focused on measuring degenerative joint disease, temporomandibular joint
Eligibility Criteria
Inclusion Criteria: The following diagnostic criteria for patient selection are to be used:
- Patients will need to have a history of chronic pain (at least 3 months) refractory to conservative therapy with non-steroidal anti-inflammatory medications, muscle relaxants, diet modifications and splint therapy
- Patients will also need to have imaging findings (radiography or magnetic resonance imaging) that show mild to severe degenerative changes of the temporomandibular joint
Exclusion Criteria: Exclusion criteria will include
- Patients with systemic disorders such as rheumatic diseases, hematologic diseases, active infections, immunosuppression
- Patients receiving therapy with anticoagulants
Sites / Locations
- Kaiser Permanente Los Angeles Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group A (corticosteroid injection group)
Group B (platelet rich plasma injection)
Arm Description
Group A will receive one intra-articular injection of 2 ml of solution containing 1ml of 10mg/ml Triamcinolone suspended in 1 ml of 0.5% Bupivacaine solution per affected joint
Group B will receive a 2 ml intra-articular injection of a platelet rich plasma preparation per affected joint
Outcomes
Primary Outcome Measures
Pain relief
Changes in pain relief will be evaluated at 1, 3, and six month intervals using the Pain resource centers TMJ scale.
Secondary Outcome Measures
Improvement in function
The patients improvement in function will be evaluated at 1,3, and 6 months for improvement using the pain resource centers TMJ scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01920373
Brief Title
Platelet-Rich Plasma vs Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint
Official Title
Platelet-Rich Plasma Versus Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
The study was cancelled.
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
1.0 BACKGROUND AND HYPOTHESES
1.1 Osteoarthritis is a continuous and entirely physiologic adaptive process that occurs in every joint. These include the replication of cells that produce matrix, enzymes, protease inhibitors, cytokines, and other peptides. Along with the synthesis of new tissue there is a release of breakdown products into the synovial fluid. Enzymes and phagocytes are required to clear these breakdown products. Normal tissue turnover involves synthesis and breakdown in well-regulated balance. In the degenerative state this balance is upset producing inflammation-derived alterations to the synovium, cartilage, capsule, tendons, and bone. Common causes of such alterations include increased loading, physical stress, and traumatic injury to the joint.
1.2 The rationale for the use of corticosteroids in temporomandibular joint therapy is that they inhibit prostaglandin synthesis and decrease the activity of collagenase and other enzymes that degrade the articular cartilage. Platelet rich plasma is a novel therapeutic agent that has several potential advantages over corticosteroids for the treatment of degenerative pathology of the temporomandibular joint. Platelet rich plasma has been shown to have anti-inflammatory, analgesic, and anti-bacterial properties. It also restores intra-articular hyaluronic acid, increases glycosaminoglycan condrocyte synthesis, balances joint angiogenesis, and provides a scaffold for stem cell migration. Autologous platelet rich plasma injections for treatment of knee cartilage degenerative lesions and osteoarthritis have shown longer efficacy than hyaluronic acid injections in reducing pain and recovering articular function. Similarly, platelet rich plasma has shown to have better outcomes than corticosteroid injections in the management of lateral epicondylitis, and better outcomes than hyaluronic acid injections in the management of osteochondral lesions of the talus.
1.3 Current treatments for degeneration and osteoarthritis of the temporomandibular joint are focused primarily on palliation by reducing inflammation and inflammatory mediators. This study seeks to validate a therapeutic agent that has the potential to actively prevent the progression of degeneration in addition to reducing pain and inflammation
Detailed Description
2.0 OBJECTIVES AND PURPOSE
2.1 The purpose of this study is to compare the efficacy, in terms of pain relief and improvement in function, of intra-articular injections with platelet rich plasma versus the current standard which is corticosteroid injections into the temporomandibular joint.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Joint Disease
Keywords
degenerative joint disease, temporomandibular joint
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (corticosteroid injection group)
Arm Type
Active Comparator
Arm Description
Group A will receive one intra-articular injection of 2 ml of solution containing 1ml of 10mg/ml Triamcinolone suspended in 1 ml of 0.5% Bupivacaine solution per affected joint
Arm Title
Group B (platelet rich plasma injection)
Arm Type
Experimental
Arm Description
Group B will receive a 2 ml intra-articular injection of a platelet rich plasma preparation per affected joint
Intervention Type
Drug
Intervention Name(s)
Group A (corticosteroid injection group)
Intervention Type
Biological
Intervention Name(s)
Group B (platelet rich plasma injection group)
Primary Outcome Measure Information:
Title
Pain relief
Description
Changes in pain relief will be evaluated at 1, 3, and six month intervals using the Pain resource centers TMJ scale.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Improvement in function
Description
The patients improvement in function will be evaluated at 1,3, and 6 months for improvement using the pain resource centers TMJ scale.
Time Frame
24 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The following diagnostic criteria for patient selection are to be used:
Patients will need to have a history of chronic pain (at least 3 months) refractory to conservative therapy with non-steroidal anti-inflammatory medications, muscle relaxants, diet modifications and splint therapy
Patients will also need to have imaging findings (radiography or magnetic resonance imaging) that show mild to severe degenerative changes of the temporomandibular joint
Exclusion Criteria: Exclusion criteria will include
Patients with systemic disorders such as rheumatic diseases, hematologic diseases, active infections, immunosuppression
Patients receiving therapy with anticoagulants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Husam G Elias, MD, DMD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julian J Wilson, DDS
Organizational Affiliation
Kaiser Permanente
Official's Role
Study Chair
Facility Information:
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Platelet-Rich Plasma vs Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint
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