Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT06850194
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2025-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vertical Ramus Osteotomy With Iliac Graft Versus Sagittal Split Osteotomy
Sponsor:
Fayoum University
Organization:
Study Overview
Official Title:
Evaluating the Efficacy of Vertical Ramus Osteotomy With Iliac Graft Versus Bilateral Sagittal Split Osteotomy for the Correction of Mandibular Deficiency in Skeletal Class II Cases Management. A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-02
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:
* Patients will be collected from faculty of dentistry
* bilateral vertical ramus osteotomy (VRO )with iliac graft group (group I):- 10 patients will be treated via VRO and iliac crest or
* bilateral sagital spilt osteotomy (BSSO) group (group II):- 10 patients will be treated via BSSO
* All patients will be studied by comprehensive clinical oral and maxillofacial examination and lateral cephalometric radiographic analyses, within 1 week before the surgery (T0), immediately after the surgery (T1), and 6 months after surgery (T2).
* All lateral cephalometric radiographs and clinical photographs must be standardized for all cases.
* After pre-surgical orthodontic treatment , a lateral cephalograph Will be obtained for planning the surgical movement of both jaws
* Surgical models and surgical stent will be fabricated.
* All surgical procedures will be performed under nasal intubation and general anesthesia to surgically reposition the maxilla in standard LeFort I setback fosteotomy; the BSSO group will be underwent BSSO, and VRO group will be underwent VRO
* The bony segments will be fixed in the new position with the use of custom made plates (specific for each patient )
* bilateral vertical ramus osteotomy (VRO )with iliac graft group (group I):- 10 patients will be treated via VRO and iliac crest or
* bilateral sagital spilt osteotomy (BSSO) group (group II):- 10 patients will be treated via BSSO
* All patients will be studied by comprehensive clinical oral and maxillofacial examination and lateral cephalometric radiographic analyses, within 1 week before the surgery (T0), immediately after the surgery (T1), and 6 months after surgery (T2).
* All lateral cephalometric radiographs and clinical photographs must be standardized for all cases.
* After pre-surgical orthodontic treatment , a lateral cephalograph Will be obtained for planning the surgical movement of both jaws
* Surgical models and surgical stent will be fabricated.
* All surgical procedures will be performed under nasal intubation and general anesthesia to surgically reposition the maxilla in standard LeFort I setback fosteotomy; the BSSO group will be underwent BSSO, and VRO group will be underwent VRO
* The bony segments will be fixed in the new position with the use of custom made plates (specific for each patient )
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: