Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-04-05 @ 8:00 PM
Study NCT ID:
NCT02120495
Status:
UNKNOWN
Last Update Posted:
2014-11-20
First Post:
2014-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Digital Techniques in Intraoral Condylectomy Via Coronoid Process Resection
Sponsor:
Peking University
Organization:
Study Overview
Official Title:
Application of Digital Techniques in Intraoral Condylectomy Via Coronoid Process Resection
Status:
UNKNOWN
Status Verified Date:
2014-11
Last Known Status:
RECRUITING
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:
This study will apply the digital techniques to do the condylectomy through an intraoral approach without needing to do the intraoral vertical ramus osteotomy (IVRO). This new surgical technique will greatly maintain the TMJ anatomy structure, reduce the risk and increase the precision of the operation procedure.
Detailed Description:
In this study we will use the digital techniques such as pre-surgical visual treatment planning, real time surgical navigation system, endoscope techniques, to do the intraoral condylectomy via coronoid process resection. After the condyle lesion resection, the coronoid process will be reimplanted and fixed by stainless steel wire. By using these techniques we can safely and precisely cut proper size and position of the condyle lesion as we pre-surgically designed, and at the same time greatly maintain the temporomandibular joint anatomy structure. Since we don't need to do the mandible vertical ramus osteotomy, and no conventional extraoral incision will be needed, the surgical injury will be minimized and the TMJ function will recover soon postoperatively. Additionally, the intraoral approach can avoid the risk of facial nerve injury, salivary fistula and skin scar, so it has better aesthetic results than the preauricular approach and the submandibular approach.
Study Oversight
Has Oversight DMC:
True
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?: