Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT06132802
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2023-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Anterior Repositioning Guided Splint Combined With or Without I Platelet-rich Fibrin
Sponsor:
Mahmoud Mohammed Mahmoud Nasef
Organization:
Study Overview
Official Title:
Evaluation of Anterior Repositioning Guided Splint Combined With or Without Injectable Platelet-rich Fibrin in Treatment of TMJ Internal Derangement.
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to evaluate clinically and radiographically the effectiveness of arthrocentesis and injection of I-PRF with wearing ARS in comparison to arthrocentesis and ARS only.
Detailed Description:
The patient will be seated at a 45° angle with the head turned toward the unaffected side. After preparing and disinfecting the target site with betadine, two points will be marked over the affected joint. Local anesthesia will be administered to block the auriculotemporal nerve. Using 19-gauge needles, the superior joint space will be distended with 2-3 ml of Ringer's solution. Another needle will be inserted into the distended compartment near the articular eminence to facilitate solution flow. Lactated Ringer's solution, connected to one needle, will be infused with sufficient pressure (200 mL in 15-20 minutes) to release adhesions. Following the removal of one needle, 2 ml of injectable platelet-rich fibrin (PRF) will be injected into the superior joint space.
For the preparation of injectable PRF, 20 ml of the patient's blood will be drawn and divided into two 10 ml vaccutainers. After centrifugation, the obtained PRF will be aspirated into a 5 ml syringe, and 1.5 to 2 ml of PRF will be injected into the superior joint space.
For the preparation of injectable PRF, 20 ml of the patient's blood will be drawn and divided into two 10 ml vaccutainers. After centrifugation, the obtained PRF will be aspirated into a 5 ml syringe, and 1.5 to 2 ml of PRF will be injected into the superior joint space.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: