Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425263
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-17
Brief Title:
Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis
Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells but no application has ever been reported in the temporomandibular joint
Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells but no application has ever been reported in the temporomandibular joint
Detailed Description:
Rationale for conducting the research
The rationale of this procedure is to remove inflammatory mediators reduce friction stimulate the production of new synovial fluid eliminate suction-cup effect
The purpose of this study was to evaluate the hypothesis that TMJ arthrocentesis with intraarticular injection of autologous micro fragmented adipose tissue leads to better clinical outcomes in terms of reducing pain and improving function
compared with arthrocentesis and intraarticular injection of hyaluronic acid HA in patients with TMJ internal derangement and osteoarthritis
Preliminary results of this clinical trial show that the injection of micro fragmented adipose tissue can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic
Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function
For this reason this protocol has been designed with the aim to investigate whether injection in the TMJ of micro fragmented fat tissue can achieve the same improvements of pain and function compare this technique with standard arthrocentesis with HA injection
The rationale of this procedure is to remove inflammatory mediators reduce friction stimulate the production of new synovial fluid eliminate suction-cup effect
The purpose of this study was to evaluate the hypothesis that TMJ arthrocentesis with intraarticular injection of autologous micro fragmented adipose tissue leads to better clinical outcomes in terms of reducing pain and improving function
compared with arthrocentesis and intraarticular injection of hyaluronic acid HA in patients with TMJ internal derangement and osteoarthritis
Preliminary results of this clinical trial show that the injection of micro fragmented adipose tissue can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic
Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function
For this reason this protocol has been designed with the aim to investigate whether injection in the TMJ of micro fragmented fat tissue can achieve the same improvements of pain and function compare this technique with standard arthrocentesis with HA injection
Study Oversight
Has Oversight DMC:
None
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?:
None