Vertical Ramus Osteotomy With Iliac Graft Versus Sagittal Split Osteotomy

NCT06850194 | Recruiting DMC

• 1 other identifier: 111
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 )

Conditions

Mandibular Deficiency

Outcome Measures

Primary Outcomes (1)

• skeletal stability

  Skeletal stability will be assessed by lateral cephalometric x-ray. It will be done pre operatively, immediate postoperative, and 6 months later

  6 months

Study Arms (2)

Bilateral Sagittal Split Osteotomy Group

ACTIVE COMPARATOR

Procedure: bilateral sagittal splitting osteotomy

vertical ramus osteotomy with iliac graft group

EXPERIMENTAL

Procedure: vertical ramus osteotomy with iliac graft

Interventions

vertical ramus osteotomy with iliac graft PROCEDURE

in the VRO group all patient will undergo vertical ramus osteotomy surgery with iliac graft to correct the sever mandibular defficiency

vertical ramus osteotomy with iliac graft group

bilateral sagittal splitting osteotomy PROCEDURE

all patients in this group will undergo to bilateral sagittal split osteotomy to correct the sever mandibular deficiency

Bilateral Sagittal Split Osteotomy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with age above 18 years old suffered from skeletal class II with severe mandibular deficiency

You may not qualify if:

• patients with chin deviation,
• severe temporomandibular joint (TMJ) symptoms.
• Sever periodontal disease
• pregnancy,
• previous mandibular surgery,
• inability to follow-up for the study protocol

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Beni-Suief University

Beni-seuf, Egypt, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Micrognathism

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor oral and maxillofacial surgery

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 27, 2025
• Study Start: February 15, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 27, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

EG (1)