Platelet-Rich Plasma vs Corticosteroid Injection as Treatment for Degenerative Pathology of the Temporomandibular Joint

NCT ID: NCT01920373

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30

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.

Conditions

Degenerative Joint Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Group A (corticosteroid injection group)

Intervention Type: DRUG

Group B (platelet rich plasma injection)

Group B will receive a 2 ml intra-articular injection of a platelet rich plasma preparation per affected joint

Group Type: EXPERIMENTAL

Group B (platelet rich plasma injection group)

Intervention Type: BIOLOGICAL

Interventions

Group A (corticosteroid injection group)

Intervention Type: DRUG

Group B (platelet rich plasma injection group)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• Patients with systemic disorders such as rheumatic diseases, hematologic diseases, active infections, immunosuppression
• Patients receiving therapy with anticoagulants

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Husam G Elias, MD, DMD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Julian J Wilson, DDS

Role: STUDY_CHAIR

Kaiser Permanente

Locations

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

468485

Identifier Type: -

Identifier Source: org_study_id