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The aim of this study is to evaluate the efficacy of intra-articular injection of platelet rich plasma versus hyaluronic acid following diagnostic arthroscopy in the management of patients suffering from degenerative temporomandibular joint (TMJ).
This is a prospective randomized study of 20 patients with TMJ degenerative joint diseases Wilkes IV, V.
Patients will be divided into two groups; Group A: will be treated with operative arthroscopy plus intra-articular platelet rich plasma.
Group B: will be treated with operative arthroscopy plus intra-articular hyaluronic acid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arthroscopy plus platelet rich plasma. | Active Comparator | Group A: will be treated with operative arthroscopy plus intra-articular injection of platelet rich plasma |
|
| arthroscopy plus hyaluronic acid. | Active Comparator | Group B: will be treated with operative arthroscopy plus intra-articular injection of hyaluronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporomandibular joint arthroscopy plus intra-articular injection | Procedure | patients with TMJ degenerative joint diseases Wilkes stages IV, V not responding to conservative treatment will undergo operative diagnostic arthroscopic treatment then at the end of the procedure intra-articular injection of platelet rich plasma or hyaluronic acid will be done. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Interincisal Opening (MIO) Measurements | change in maximum inter-incisal mouth opening will be measured in millimeters between preoperative and postoperative at 1 week,3 weeks, the every month till 6 months | change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative |
| Pain Intensity Measurements | A 100 -point visual analogue scale (VAS) for the assessment of pain intensity with 0 as the absence of pain and 100 as the worst pain imaginable With filled standardized charts. | change from preoperative pain intensity according to 100 -point visual analogue scale at 6 months postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samia M Saied, MD | Professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag University | Sohag | 82525 | Egypt |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arthroscopy Plus Platelet Rich Plasma. | Group A: will be treated with operative arthroscopy plus intra-articular injection of platelet rich plasma Temporomandibular joint arthroscopy plus intra-articular injection: patients with TMJ degenerative joint diseases Wilkes stages IV, V not responding to conservative treatment will undergo operative arthroscopic treatment then at the end of the procedure intra-articular injection of platelet rich plasma. |
| FG001 | Arthroscopy Plus Hyaluronic Acid. | Group B: will be treated with operative arthroscopy plus intra-articular injection of hyaluronic acid Temporomandibular joint arthroscopy plus intra-articular injection: patients with TMJ degenerative joint diseases Wilkes stages IV, V not responding to conservative treatment will undergo operative arthroscopic treatment then at the end of the procedure intra-articular injection of hyaluronic acid . |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arthroscopy Plus Platelet Rich Plasma. | Group A: will be treated with operative arthroscopy plus intra-articular injection of platelet rich plasma Temporomandibular joint arthroscopy plus intra-articular injection: patients with TMJ degenerative joint diseases Wilkes stages IV, V not responding to conservative treatment will undergo operative diagnostic arthroscopic treatment then at the end of the procedure intra-articular injection of platelet rich plasma. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Maximum Interincisal Opening (MIO) Measurements | change in maximum inter-incisal mouth opening will be measured in millimeters between preoperative and postoperative at 1 week,3 weeks, the every month till 6 months | Posted | Mean | Standard Deviation | Millimeter | change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative |
|
23 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arthroscopy Plus Platelet Rich Plasma. | Group A: will be treated with operative arthroscopy plus intra-articular injection of platelet rich plasma Temporomandibular joint arthroscopy plus intra-articular injection: patients with TMJ degenerative joint diseases Wilkes stages IV, V not responding to conservative treatment will undergo operative diagnostic arthroscopic treatment then at the end of the procedure intra-articular injection of platelet rich plasma. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Magdy Mohamed Amien | Soahg University | 0934602963 | portal@med.sohag.edu.eg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2023 | May 17, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2023 | May 17, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007270 | Injections, Intra-Articular |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| BG001 | Arthroscopy Plus Hyaluronic Acid. | Group B: will be treated with operative arthroscopy plus intra-articular injection of hyaluronic acid Temporomandibular joint arthroscopy plus intra-articular injection: patients with TMJ degenerative joint diseases Wilkes stages IV, V not responding to conservative treatment will undergo operative diagnostic arthroscopic treatment then at the end of the procedure intra-articular injection of hyaluronic acid. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Arthroscopy Plus Hyaluronic Acid. |
Group B: will be treated with operative arthroscopy plus intra-articular injection of hyaluronic acid Temporomandibular joint arthroscopy plus intra-articular injection: patients with TMJ degenerative joint diseases Wilkes stages IV, V not responding to conservative treatment will undergo operative diagnostic arthroscopic treatment then at the end of the procedure intra-articular injection hyaluronic acid. |
|
|
| Primary | Pain Intensity Measurements | A 100 -point visual analogue scale (VAS) for the assessment of pain intensity with 0 as the absence of pain and 100 as the worst pain imaginable With filled standardized charts. | Posted | Mean | Standard Deviation | score on a scale | change from preoperative pain intensity according to 100 -point visual analogue scale at 6 months postoperative |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Arthroscopy Plus Hyaluronic Acid. | Group B: will be treated with operative arthroscopy plus intra-articular injection of hyaluronic acid Temporomandibular joint arthroscopy plus intra-articular injection: patients with TMJ degenerative joint diseases Wilkes stages IV, V not responding to conservative treatment will undergo operative diagnostic arthroscopic treatment then at the end of the procedure intra-articular injection of hyaluronic acid. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| 3-weeks PO |
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| 1-month PO |
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| 2-months PO |
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| 3-months PO |
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| 4-months PO |
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| 5-months PO |
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| 6-months PO |
|