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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Kaiser Permanente
Sponsor:
Information provided by (Responsible Party):
Husam G. Elias, MD, Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01920373
First received: August 8, 2013
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Degenerative Joint Disease
Drug: Group A (corticosteroid injection group)
Biological: Group B (platelet rich plasma injection group)
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
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)
Arms Assigned Interventions
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)

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01920373

Contacts
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

Locations
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         
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Husam G Elias, MD, DMD Kaiser Permanente
Study Chair: Julian J Wilson, DDS Kaiser Permanente
  More Information

No publications provided

Responsible Party: Husam G. Elias, MD, Physician, Division of Maxillofacial Surgery, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01920373     History of Changes
Other Study ID Numbers: 468485
Study First Received: August 8, 2013
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Kaiser Permanente:
degenerative joint disease
temporomandibular joint

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 21, 2014