Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT07118605
Status:
COMPLETED
Last Update Posted:
2025-08-12
First Post:
2025-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minimally Invasive Sagittal Split Ramus Osteotomy
Sponsor:
TC Erciyes University
Organization:
Study Overview
Official Title:
Exploring the Potential of Minimally Invasive Sagittal Split Ramus Osteotomy to Transform Patient Outcomes: A Randomized, Double-Blind, Controlled Split Mouth Study
Status:
COMPLETED
Status Verified Date:
2025-07
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:
This randomized, double-blind, controlled, split-mouth clinical trial investigates the effects of two different surgical approaches - the conventional technique and a minimally invasive technique - during bilateral sagittal split ramus osteotomy (SSRO) for mandibular deformity correction. The study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Erciyes University.
Each patient will receive both surgical techniques, randomly assigned to either side of the mandible. All procedures will be performed under general anesthesia by the same surgeon. Intraoperative outcomes including bleeding volume and operative time will be recorded. Postoperative evaluations will be conducted on day 1, weeks 1, 2, and 4, and at 3 months to assess pain and swelling.
This study aims to determine whether the minimally invasive SSRO technique can improve surgical efficiency and reduce postoperative morbidity compared to the conventional approach, without compromising treatment outcomes.
Each patient will receive both surgical techniques, randomly assigned to either side of the mandible. All procedures will be performed under general anesthesia by the same surgeon. Intraoperative outcomes including bleeding volume and operative time will be recorded. Postoperative evaluations will be conducted on day 1, weeks 1, 2, and 4, and at 3 months to assess pain and swelling.
This study aims to determine whether the minimally invasive SSRO technique can improve surgical efficiency and reduce postoperative morbidity compared to the conventional approach, without compromising treatment outcomes.
Detailed Description:
None
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?: