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RecruitingNCT06850194Updated Feb 28, 2025

Vertical Ramus Osteotomy With Iliac Graft Versus Sagittal Split Osteotomy

An interventional study of vertical ramus osteotomy with iliac graft and bilateral sagittal splitting osteotomy in Mandibular Deficiency, sponsored by Fayoum University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Fayoum University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 )
02

Conditions studied

  • Mandibular Deficiency

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03

In context

Micrognathism

26 studies on the registry are indexed under Micrognathism; 7 are open to participants now.

This study's planned enrollment of 20 is below the median of 24 across 22 interventional studies indexed under Micrognathism.

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Lead sponsor

Fayoum University is the lead sponsor of 148 studies on the registry; 44 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with chin deviation,
  • severe temporomandibular joint (TMJ) symptoms.
  • Sever periodontal disease
  • pregnancy,
  • previous mandibular surgery,
  • inability to follow-up for the study protocol
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Bilateral Sagittal Split Osteotomy Group

    Procedure: bilateral sagittal splitting osteotomy

  • Experimental
    vertical ramus osteotomy with iliac graft group

    Procedure: vertical ramus osteotomy with iliac graft

Interventions

  • Procedurevertical ramus osteotomy with iliac graft

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

  • Procedurebilateral sagittal splitting osteotomy

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

06

What researchers measure

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

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Beni-Suief University
    Beni-seuf, 02, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06850194
Lead sponsor
Fayoum University
Responsible party
Shaimaa Mohsen (associate professor oral and maxillofacial surgery, Fayoum University) — Principal investigator
First posted
Feb 27, 2025
Start date
Feb 15, 2025
Primary completion
Feb 1, 2026 (estimated)
Completion
Feb 27, 2026 (estimated)
Last update
Feb 28, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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