Platelet-Rich Plasma Versus Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint
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
Degenerative Joint Disease
Drug: Group A (corticosteroid injection group)
Biological: Group B (platelet rich plasma injection group)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
|Official Title:||Platelet-Rich Plasma Versus Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint|
- Pain relief [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Changes in pain relief will be evaluated at 1, 3, and six month intervals using the Pain resource centers TMJ scale.
- Improvement in function [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]The patients improvement in function will be evaluated at 1,3, and 6 months for improvement using the pain resource centers TMJ scale.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Group A (corticosteroid injection group)
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
|Drug: Group A (corticosteroid injection group)|
Experimental: Group B (platelet rich plasma injection group)
Group B will receive a 2 ml intra-articular injection of a platelet rich plasma preparation per affected joint
|Biological: Group B (platelet rich plasma injection group)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01920373
|Contact: Julian J Wilson, DDS||310-738-0412||Julian.J.Wilson@kp.org|
|Contact: Husam G Elias, MD, DMD||310-703-0151||Husam.G.Elias@kp.org|
|United States, California|
|Kaiser Permanente Los Angeles Medical Center||Not yet recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Julian J Wilson, DDS 310-783-0412 Julian.J.Wilson@kp.org|
|Principal Investigator: Husam G Elias, MD, DMD|
|Sub-Investigator: Julian J Wilson, DDS|
|Principal Investigator:||Husam G Elias, MD, DMD||Kaiser Permanente|
|Study Chair:||Julian J Wilson, DDS||Kaiser Permanente|