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NCT Number: NCT06850194

Vertical Ramus Osteotomy With Iliac Graft Versus Sagittal Split Osteotomy

* 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 )

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Key information

Conditions

Mandibular Deficiency Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Micrognathism Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

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

bilateral sagittal splitting osteotomy

Procedure

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

Primary outcomes

  1. skeletal stability

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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