Clinical trial NCT04731233
Conditions: TMJ Osteoarthritis
Sponsor: University of Florida
Start date: 2021-03-30; Completion date: 2024-02-21
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

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.

Arms: arm 1: The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure. arm 2: 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.
Interventions: intervention 1: Plasma Rich in Growth Factor (PRGF) Supplementation intervention 2: Triamcinolone Acetonide
Intervention descriptions: intervention 1: 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. intervention 2: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.

Protocol documents:
Prot_000.pdf: 
 
 
Clinical Trial Number: NCT04731233 
 
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)   
 
Date: January 2, 2025 
 
 
 
Protocol 
 
 


Protocol: 
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 arthritis, 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. 

SAP_001.pdf: 
 
 
Clinical Trial Number: 
NCT04731233 
 
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) 
 
Date: January 2, 2025 
 
 
 
 
Proposed Statistical Analyses 
 
 


 
Statistical Analyses 
Statistical analyses will consist of descriptive statistics (mean, standard deviation for parametric 
data; median and range for non-parametric data) and inferential statistics (two way ANOVA, 1 
between (treatment groups), 1 within (time)) using a probability level of < 0.05).  The primary 
outcome variable will be intracapsular pain.