Efficacy of PRGF Supplementation After TMJ Arthrocentesis in Patients With TMJ Osteoarthritis

• ClinicalTrials.gov Identifier: NCT04731233
• Recruitment Status: Recruiting
• First Posted: January 29, 2021
• Last Update Posted: January 18, 2022
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Study Description

Brief Summary:

Temporomandibular joint (TMJ) osteoarthritis (OA) affects articulating tissues secondary to inflammation resulting in intracapsular pain. This prospective, double-blind randomized clinical trial will evaluate the relative efficacy of TMJ arthrocentesis with a supplementation of platelet-rich growth factors (PRGF) compared to TMJ arthrocentesis with a steroid supplementation (a known effective therapy) for patients with TMJ OA.

Condition or disease	Intervention/treatment	Phase
TMJ; Osteoarthritis	Biological: Plasma Rich in Growth Factor (PRGF) Supplementation; Drug: Triamcinolone Acetonide	Phase 4

Detailed Description:

Temporomandibular disorders (TMD) are musculoskeletal disorders that are commonly encountered, with pain in the temporomandibular joint (TMJ) and jaw closing muscles. Pain that involves the temporomandibular joint includes inflammatory pathologies such as arthritides, painful disk displacements and many times have an overlay of psychosocial comorbidities due to the uncontrolled pain. TMJ osteoarthritis is an intracapsular condition affecting the temporomandibular joint and presents with remodeling of the TMJ articulating tissues including the condyle and articular eminence secondary to inflammation resulting in intracapsular pain. There is a paucity of information regarding the relative effectiveness of different therapies for the treatment of patients with TMJ osteoarthritis. The identification of the least invasive and most efficacious therapy is vital to proper management of these patients with temporomandibular joint pain and disability. The purpose of this study is to establish the relative efficacy of TMJ arthrocentesis with steroid supplementation (a known effective therapy) compared to TMJ arthrocentesis with a supplement of plasma rich in growth factors (PRGF) for patients with TMJ osteoarthritis. Plasma rich in growth factors is isolated from the patient's own blood and injected into the temporomandibular joint to activate stem cells that may restore some of the articulating tissues that were lost during degeneration changes within the joint secondary to osteoarthritis. Pain and disability will be assessed using standard pain and physical measures that are recorded before and after treatment. Patients enrolled into the study will be examined and treated at the Department of Oral and Maxillofacial Surgery Faculty/Resident clinic. At the first appointment, they will be examined following standard procedures (medical history, physical exam, imaging by cone beam computerized tomography (CBCT)) to determine their diagnosis(es) and if they would potentially benefit from the TMJ arthrocentesis procedure. If the patient meets the inclusion criteria for the study and with their informed consent on the day of their TMJ arthrocentesis procedure, they will be required to have a pregnancy test if below age 60 and complete a questionnaire about their physical and pain symptoms and undergo a standardized clinical exam. The patients will then undergo the standard clinical protocol for TMJ arthrocentesis followed by either a 2 cc steroid/bupivacaine hydrochloride supplementation (standard treatment group) or a 2 cc PRGF supplementation (experimental group) into the TMJ. Follow-up appointments will be conducted at 1 month, 3 months and 6 months when the pain VAS measures and a clinical exam will be assessed. If patients have not experienced improvement in their primary outcome measure (TMJ pain) at the 3 month evaluation, the patient will have a second TMJ arthrocentesis procedure that will be supplemented with the alternative medication/growth factors (steroid or PRGF) using a cross-over design. Data from these patients will be analyzed separately from patients that complete the six month study. Also at 6 months, a second CBCT image of the temporomandibular joints will be obtained to determine the extent of bone remodeling within the TMJ. The results of this study should provide new information on the efficacy of PRGF supplementation for management of temporomandibular joint osteoarthritis.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind Study of the Efficacy of Platelet-Rich Growth Factor (PRGF) Supplementation Compared to Steroid Supplementation After Temporomandibular Joint (TMJ) Arthrocentesis in Female Patients With TMJ Osteoarthritis (OA)
• Actual Study Start Date: March 30, 2021
• Estimated Primary Completion Date: March 2023
• Estimated Study Completion Date: September 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: PRGF Arm; The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure.	Biological: Plasma Rich in Growth Factor (PRGF) Supplementation; After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes.
Active Comparator: Steroid Arm; Two cc containing 40 mg of triamcinolone acetonide with 5 mg bupivacaine will be infused into the upper joint space after the TMJ arthrocentesis procedure.	Drug: Triamcinolone Acetonide; After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.; Other Name: Kenalog

Outcome Measures

Primary Outcome Measures :

1. Visual Analog Scale Measurement (VAS) of Intracapsular Pain Intensity [ Time Frame: Baseline up to 6 months ]
   To compare the VAS measure of intracapsular pain intensity before (baseline) and after the procedure. VAS measurement provides a range of scores from 0-100. A higher score indicates greater pain intensity.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Only females will be studied since greater than 95% of the patients that pursue temporomandibular joint arthrocentesis are female.
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Female
• 40 - 80 years of age
• Unilateral or bilateral TMJ arthralgia
• Osteoarthritis diagnosis according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
• TMJ sounds (crepitus or click or both)
• Mild-moderate masticatory muscle myalgia
• History of non-surgical treatment for at least 6 weeks including such modalities as appliance therapy, NSAID therapy or physical modalities without resolution of pain

Exclusion Criteria:

• Contraindication to sedation including pregnancy or medical history
• Rheumatologic disorders causing arthritis of the temporomandibular joint (i.e., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis)
• History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy
• History of steroid injection in TMJ
• TMJ pain greater than five years
• History of narcotic drug use on a scheduled basis
• Current active infection
• Fibromyalgia

Contacts and Locations

Contacts

Contact: Charles G. Widmer, DDS; 352-273-5696; widmer@dental.ufl.edu

Locations

United States, Florida

University of Florida; Recruiting

Gainesville, Florida, United States, 32610

Principal Investigator: Charles Widmer, D.D.S

Sponsors and Collaborators

University of Florida

Investigators

• Principal Investigator: Charles G. Widmer, DDS; University of Florida

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT04731233
• Other Study ID Numbers: IRB202000689-A; OCR40106 ( Other Identifier: UF OnCore )
• First Posted: January 29, 2021
• Last Update Posted: January 18, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Mitogens; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators