Temporomandibular Joint Disorders
Conditions
Brief summary
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.
Interventions
PROCEDURETemporomandibular 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 or hyaluronic acid will be done.
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \- All patients with reduced mouth opening and/or painful maximum mouth opening. * Joint pain. * Patients with radiological evidence of degenerative joint disease. * Patients with unsuccessful medical conservative treatment for at least two months. * Unilateral or bilateral temporomandibular joint involvement. * Wilkes stages IV and V
Exclusion criteria
* \- Patients with bony ankylosis . * Patients with advanced resorption of the glenoid fossa. * Patients with infection or tumors around joint area * Patients unfit for intervention medically. * Patients who refused to share in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Interincisal Opening (MIO) Measurements | change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative | 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 |
| Pain Intensity Measurements | change from preoperative pain intensity according to 100 -point visual analogue scale at 6 months postoperative | 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. |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Arthroscopy Plus Hyaluronic Acid. | Total | Arthroscopy Plus Platelet Rich Plasma. |
|---|---|---|---|
| Age, Continuous | 31.9 years STANDARD_DEVIATION 9.94 | 31.9 years STANDARD_DEVIATION 9.94 | 31.9 years STANDARD_DEVIATION 9.94 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Egypt | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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
Time frame: change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arthroscopy Plus Platelet Rich Plasma. | Maximum Interincisal Opening (MIO) Measurements | 1-week PO | 33.8 Millimeter | Standard Deviation 3.43 |
| Arthroscopy Plus Platelet Rich Plasma. | Maximum Interincisal Opening (MIO) Measurements | 3-months PO | 37.6 Millimeter | Standard Deviation 4.55 |
| Arthroscopy Plus Platelet Rich Plasma. | Maximum Interincisal Opening (MIO) Measurements | 1-month PO | 36.7 Millimeter | Standard Deviation 5.08 |
| Arthroscopy Plus Platelet Rich Plasma. | Maximum Interincisal Opening (MIO) Measurements | 4-months PO | 37.1 Millimeter | Standard Deviation 4.41 |
| Arthroscopy Plus Platelet Rich Plasma. | Maximum Interincisal Opening (MIO) Measurements | 3-weeks PO | 36 Millimeter | Standard Deviation 4.4 |
| Arthroscopy Plus Platelet Rich Plasma. | Maximum Interincisal Opening (MIO) Measurements | 5-months PO | 36.8 Millimeter | Standard Deviation 4.78 |
| Arthroscopy Plus Platelet Rich Plasma. | Maximum Interincisal Opening (MIO) Measurements | 2-months PO | 36.7 Millimeter | Standard Deviation 5.08 |
| Arthroscopy Plus Platelet Rich Plasma. | Maximum Interincisal Opening (MIO) Measurements | 6-months PO | 36.9 Millimeter | Standard Deviation 4.95 |
| Arthroscopy Plus Platelet Rich Plasma. | Maximum Interincisal Opening (MIO) Measurements | Pre-operative | 23.1 Millimeter | Standard Deviation 6.71 |
| Arthroscopy Plus Hyaluronic Acid. | Maximum Interincisal Opening (MIO) Measurements | 6-months PO | 38.5 Millimeter | Standard Deviation 4.33 |
| Arthroscopy Plus Hyaluronic Acid. | Maximum Interincisal Opening (MIO) Measurements | Pre-operative | 27.9 Millimeter | Standard Deviation 4.51 |
| Arthroscopy Plus Hyaluronic Acid. | Maximum Interincisal Opening (MIO) Measurements | 1-week PO | 35.6 Millimeter | Standard Deviation 3.96 |
| Arthroscopy Plus Hyaluronic Acid. | Maximum Interincisal Opening (MIO) Measurements | 3-weeks PO | 36.7 Millimeter | Standard Deviation 4.92 |
| Arthroscopy Plus Hyaluronic Acid. | Maximum Interincisal Opening (MIO) Measurements | 1-month PO | 37.3 Millimeter | Standard Deviation 5.5 |
| Arthroscopy Plus Hyaluronic Acid. | Maximum Interincisal Opening (MIO) Measurements | 2-months PO | 37.6 Millimeter | Standard Deviation 5.21 |
| Arthroscopy Plus Hyaluronic Acid. | Maximum Interincisal Opening (MIO) Measurements | 3-months PO | 38.2 Millimeter | Standard Deviation 4.71 |
| Arthroscopy Plus Hyaluronic Acid. | Maximum Interincisal Opening (MIO) Measurements | 4-months PO | 38 Millimeter | Standard Deviation 4.29 |
| Arthroscopy Plus Hyaluronic Acid. | Maximum Interincisal Opening (MIO) Measurements | 5-months PO | 38.3 Millimeter | Standard Deviation 4.06 |
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.
Time frame: change from preoperative pain intensity according to 100 -point visual analogue scale at 6 months postoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arthroscopy Plus Platelet Rich Plasma. | Pain Intensity Measurements | 1-week PO | 28 score on a scale | Standard Deviation 14.76 |
| Arthroscopy Plus Platelet Rich Plasma. | Pain Intensity Measurements | 3-months PO | 12 score on a scale | Standard Deviation 7.89 |
| Arthroscopy Plus Platelet Rich Plasma. | Pain Intensity Measurements | 1-month PO | 16 score on a scale | Standard Deviation 9.66 |
| Arthroscopy Plus Platelet Rich Plasma. | Pain Intensity Measurements | 4-months PO | 12 score on a scale | Standard Deviation 10.33 |
| Arthroscopy Plus Platelet Rich Plasma. | Pain Intensity Measurements | 3-weeks PO | 21 score on a scale | Standard Deviation 8.76 |
| Arthroscopy Plus Platelet Rich Plasma. | Pain Intensity Measurements | 5-months PO | 14 score on a scale | Standard Deviation 13.5 |
| Arthroscopy Plus Platelet Rich Plasma. | Pain Intensity Measurements | 2-months PO | 13 score on a scale | Standard Deviation 6.75 |
| Arthroscopy Plus Platelet Rich Plasma. | Pain Intensity Measurements | 6-months PO | 14 score on a scale | Standard Deviation 13.5 |
| Arthroscopy Plus Platelet Rich Plasma. | Pain Intensity Measurements | preoperative | 49 score on a scale | Standard Deviation 20.79 |
| Arthroscopy Plus Hyaluronic Acid. | Pain Intensity Measurements | 6-months PO | 3 score on a scale | Standard Deviation 4.83 |
| Arthroscopy Plus Hyaluronic Acid. | Pain Intensity Measurements | preoperative | 49 score on a scale | Standard Deviation 21.32 |
| Arthroscopy Plus Hyaluronic Acid. | Pain Intensity Measurements | 1-week PO | 30 score on a scale | Standard Deviation 14.14 |
| Arthroscopy Plus Hyaluronic Acid. | Pain Intensity Measurements | 3-weeks PO | 25 score on a scale | Standard Deviation 14.34 |
| Arthroscopy Plus Hyaluronic Acid. | Pain Intensity Measurements | 1-month PO | 20 score on a scale | Standard Deviation 14.91 |
| Arthroscopy Plus Hyaluronic Acid. | Pain Intensity Measurements | 2-months PO | 13 score on a scale | Standard Deviation 9.49 |
| Arthroscopy Plus Hyaluronic Acid. | Pain Intensity Measurements | 3-months PO | 7 score on a scale | Standard Deviation 4.83 |
| Arthroscopy Plus Hyaluronic Acid. | Pain Intensity Measurements | 4-months PO | 4 score on a scale | Standard Deviation 5.16 |
| Arthroscopy Plus Hyaluronic Acid. | Pain Intensity Measurements | 5-months PO | 3 score on a scale | Standard Deviation 4.83 |