Trial Outcomes & Findings for Intra-articular Injection in Arthroscopic Management of Temporomandibular Diseases (NCT NCT04936945)
NCT ID: NCT04936945
Last Updated: 2024-09-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperative
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
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.
|
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 .
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arthroscopy Plus Platelet Rich Plasma.
n=10 Participants
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.
|
Arthroscopy Plus Hyaluronic Acid.
n=10 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.9 years
STANDARD_DEVIATION 9.94 • n=10 Participants
|
31.9 years
STANDARD_DEVIATION 9.94 • n=10 Participants
|
31.9 years
STANDARD_DEVIATION 9.94 • n=20 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Egypt
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: change from baseline maximum interincisal mouth opening in millimeters at 6 months postoperativechange 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
Outcome measures
| Measure |
Arthroscopy Plus Platelet Rich Plasma.
n=10 Participants
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.
|
Arthroscopy Plus Hyaluronic Acid.
n=10 Participants
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.
|
|---|---|---|
|
Maximum Interincisal Opening (MIO) Measurements
Pre-operative
|
23.1 Millimeter
Standard Deviation 6.71
|
27.9 Millimeter
Standard Deviation 4.51
|
|
Maximum Interincisal Opening (MIO) Measurements
1-week PO
|
33.8 Millimeter
Standard Deviation 3.43
|
35.6 Millimeter
Standard Deviation 3.96
|
|
Maximum Interincisal Opening (MIO) Measurements
3-weeks PO
|
36 Millimeter
Standard Deviation 4.4
|
36.7 Millimeter
Standard Deviation 4.92
|
|
Maximum Interincisal Opening (MIO) Measurements
1-month PO
|
36.7 Millimeter
Standard Deviation 5.08
|
37.3 Millimeter
Standard Deviation 5.5
|
|
Maximum Interincisal Opening (MIO) Measurements
2-months PO
|
36.7 Millimeter
Standard Deviation 5.08
|
37.6 Millimeter
Standard Deviation 5.21
|
|
Maximum Interincisal Opening (MIO) Measurements
3-months PO
|
37.6 Millimeter
Standard Deviation 4.55
|
38.2 Millimeter
Standard Deviation 4.71
|
|
Maximum Interincisal Opening (MIO) Measurements
4-months PO
|
37.1 Millimeter
Standard Deviation 4.41
|
38 Millimeter
Standard Deviation 4.29
|
|
Maximum Interincisal Opening (MIO) Measurements
5-months PO
|
36.8 Millimeter
Standard Deviation 4.78
|
38.3 Millimeter
Standard Deviation 4.06
|
|
Maximum Interincisal Opening (MIO) Measurements
6-months PO
|
36.9 Millimeter
Standard Deviation 4.95
|
38.5 Millimeter
Standard Deviation 4.33
|
PRIMARY outcome
Timeframe: change from preoperative pain intensity according to 100 -point visual analogue scale at 6 months postoperativeA 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.
Outcome measures
| Measure |
Arthroscopy Plus Platelet Rich Plasma.
n=10 Participants
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.
|
Arthroscopy Plus Hyaluronic Acid.
n=10 Participants
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.
|
|---|---|---|
|
Pain Intensity Measurements
preoperative
|
49 score on a scale
Standard Deviation 20.79
|
49 score on a scale
Standard Deviation 21.32
|
|
Pain Intensity Measurements
1-week PO
|
28 score on a scale
Standard Deviation 14.76
|
30 score on a scale
Standard Deviation 14.14
|
|
Pain Intensity Measurements
3-weeks PO
|
21 score on a scale
Standard Deviation 8.76
|
25 score on a scale
Standard Deviation 14.34
|
|
Pain Intensity Measurements
1-month PO
|
16 score on a scale
Standard Deviation 9.66
|
20 score on a scale
Standard Deviation 14.91
|
|
Pain Intensity Measurements
2-months PO
|
13 score on a scale
Standard Deviation 6.75
|
13 score on a scale
Standard Deviation 9.49
|
|
Pain Intensity Measurements
3-months PO
|
12 score on a scale
Standard Deviation 7.89
|
7 score on a scale
Standard Deviation 4.83
|
|
Pain Intensity Measurements
4-months PO
|
12 score on a scale
Standard Deviation 10.33
|
4 score on a scale
Standard Deviation 5.16
|
|
Pain Intensity Measurements
5-months PO
|
14 score on a scale
Standard Deviation 13.5
|
3 score on a scale
Standard Deviation 4.83
|
|
Pain Intensity Measurements
6-months PO
|
14 score on a scale
Standard Deviation 13.5
|
3 score on a scale
Standard Deviation 4.83
|
Adverse Events
Arthroscopy Plus Platelet Rich Plasma.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arthroscopy Plus Hyaluronic Acid.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place