Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530745
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-27
Brief Title:
PRP vs HA Intra-articular Injections in TMDs
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Quintuple Intra-Articular Hyaluronic Acid HA Improves and Platelet-Rich Plasma PRP Does Not Affect Mandibular Mobility in Temporomandibular Joint TMJ Disorders A Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial aims to compare the multidirectional mandibular mobility following the treatment of TMJ disorders with same-protocol intra-articular injections of PRP and HA It is questioned whether there is direct clinical evidence of the superiority of PRP or HA in the injection treatment of TMJ disorders
Detailed Description:
This study was designed as a two-arm equal-allocation clinical trial with a non-concurrent active treatment control The study group consisted of consecutive patients receiving PRP injections into the TMJ cavities The control group consisted of the same number of patients who received HA according to the same protocol Controls were recruited consecutively men and women separately to maintain a consistent male-to-female ratio The main condition for recruitment was the diagnosis of TMJ pain by a specialist in orthodontics or dental prosthetics and on this basis a referral for injection treatment TMJ pain was diagnosed under the ICOP 2020 guidelines The treatment was performed at the Maxillofacial Surgery Clinic in Kielce Poland The study group received PRP from peripheral venous blood of the elbow bend centrifuged at 160 revolutions per minute for 5 minutes with iFuge D06 Neuation Technologies Pvt Ltd Gujarat India The control group received 2 hyaluronic acid Synocrom Forte Croma-Pharma GmbH Leobendorf Austria In both groups 04 mL of the solution was injected per joint
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None