Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| OCR40106 | Other Identifier | UF OnCore |
Not provided
Not provided
Not provided
Could not recruit participants due to their refusal to be randomized in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRGF Arm | Experimental | The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure. |
|
| Steroid Arm | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma Rich in Growth Factor (PRGF) Supplementation | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating | The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain). | Three Months |
| Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating | The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain). | Six Months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Chewing Pain Measured by Visual Analog Scale (VAS) | The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain). |
Inclusion Criteria:
Exclusion Criteria:
Only females will be studied since greater than 95% of the patients that pursue temporomandibular joint arthrocentesis are female.
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles G. Widmer, DDS | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment period: 02-17-2021 to 02-21-2024 Study location: Oral and Maxillofacial Surgery Clinic
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PRGF Arm | The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure. 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. |
| FG001 | 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. Triamcinolone Acetonide: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PRGF Arm | The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating | The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain). | Posted | Mean | Standard Deviation | units on a scale | Three Months |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRGF Arm | The PRGF experimental group will have two cc of PRGF infused into the upper joint space after the TMJ arthrocentesis procedure. 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. |
Not provided
Not provided
Due to the limited number of participants in this clinical trial, the study was terminated, and a statistical analysis was not conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles G. Widmer | University of Florida | 352-273-5696 | widmer@dental.ufl.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 2, 2025 | Jan 6, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 2, 2025 | Jan 6, 2025 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D036341 | Intercellular Signaling Peptides and Proteins |
| D019587 | Dietary Supplements |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Triamcinolone Acetonide | Drug | After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine. |
|
|
| Baseline |
| Chewing Pain Measured by Visual Analog Scale (VAS) | The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain). | Six Months |
| Temporomandibular Joint Crepitus | Presence of multiple, distinct joint sounds (crepitus). | Baseline |
| Temporomandibular Joint Crepitus | Presence of multiple, distinct joint sounds (crepitus). | Six Months |
| BG001 | 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. Triamcinolone Acetonide: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Temporomandibular Joint (TMJ) Intracapsular Pain-Visual Analog Scale (VAS) Rating | The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain). | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. Triamcinolone Acetonide: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine. |
|
|
| Primary | Temporomandibular Joint (TMJ) Visual Analog Scale (VAS) Pain Rating | The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain). | Posted | Mean | Standard Error | units on a scale | Six Months |
|
|
|
| Other Pre-specified | Chewing Pain Measured by Visual Analog Scale (VAS) | The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Other Pre-specified | Chewing Pain Measured by Visual Analog Scale (VAS) | The Visual Analog Scale (VAS) is a pain rating scale that has a range of 0-100 and is represented as a 100 mm line. On this scale, 0 is represented as "no pain" and 100 is represented as "the most intense pain imaginable". Pain is measured by having the subject place a line bisecting a 100 mm line to represent the pain level and a numerical rating is obtained by measuring the distance, in mm, from the zero-pain anchor (left side of scale represented by 0 pain). | Posted | Mean | Standard Deviation | units on a scale | Six Months |
|
|
|
| Other Pre-specified | Temporomandibular Joint Crepitus | Presence of multiple, distinct joint sounds (crepitus). | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Other Pre-specified | Temporomandibular Joint Crepitus | Presence of multiple, distinct joint sounds (crepitus). | Posted | Count of Participants | Participants | Six Months |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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. Triamcinolone Acetonide: After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine. | 0 | 1 | 0 | 1 | 0 | 1 |
Not provided
Not provided
| D005502 |
| Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |