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

Degenerative Joint Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01920373
• Other study ID #: 468485
• Status: Withdrawn
• Phase: Phase 1
• First received: August 8, 2013
• Last updated: March 10, 2015
• Start date: November 2013

Study information

• Verified date: March 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Joint Diseases
• Osteoarthritis

Intervention

Drug:
• Group A (corticosteroid injection group)

Biological:
• Group B (platelet rich plasma injection group)

Locations

Country	Name	City	State
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	Changes in pain relief will be evaluated at 1, 3, and six month intervals using the Pain resource centers TMJ scale.	24 weeks	No
Secondary	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.	24 weeks	No