NCT07788976

Brief Summary

This study aims to compare the effects of the Hunsuck and Posnick modifications of medial mandibular osteotomy on postoperative skeletal stability and relapse in patients undergoing orthognathic surgery. The study will evaluate whether the choice of medial osteotomy technique influences postoperative mandibular relapse.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Jan 2026Apr 2027

Study Start

First participant enrolled

January 1, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2027

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

August 24, 2026

Last Update Submit

August 24, 2026

Conditions

Keywords

orthognathic surgeryrelapse

Outcome Measures

Primary Outcomes (1)

  • Postoperative Skeletal Relapse

    The primary outcome will be the amount and percentage of skeletal relapse between 1 month and 12 months after orthognathic surgery (T3-T1), assessed using three-dimensional cephalometric and skeletal measurements.

    1 year

Study Arms (2)

Hunsuck Modification Group

EXPERIMENTAL

Patients undergoing orthognathic surgery with bilateral sagittal split ramus osteotomy (BSSO) will undergo medial mandibular osteotomy using the Hunsuck modification. The osteotomy will be performed according to the Hunsuck technique, with the medial horizontal osteotomy terminating at the level of the lingula and extending posteriorly to facilitate the sagittal split. Postoperative skeletal stability and relapse will be evaluated during the follow-up period.

Procedure: sagittal split osteotomyProcedure: Hunsuck Modification of Medial Mandibular Osteotomy

Posnick Modification Group

ACTIVE COMPARATOR

Patients undergoing orthognathic surgery with bilateral sagittal split ramus osteotomy (BSSO) will undergo medial mandibular osteotomy using the Posnick modification. The osteotomy will be performed according to the Posnick technique, with the modified medial osteotomy design extending posteriorly in accordance with the technique. Postoperative skeletal stability and relapse will be evaluated during the follow-up period.

Procedure: sagittal split osteotomyProcedure: Posnick Modification Group

Interventions

Bilateral sagittal split ramus osteotomy will be performed as part of orthognathic surgery to correct the planned mandibular skeletal deformity. The mandibular ramus and body will be divided using the assigned medial osteotomy modification (Hunsuck or Posnick), followed by sagittal splitting of the mandible. The distal mandibular segment will then be repositioned according to the preoperative surgical plan and stabilized using appropriate osteosynthesis. Postoperative skeletal stability and mandibular relapse will be evaluated during the follow-up period.

Hunsuck Modification GroupPosnick Modification Group

The Hunsuck modification of the medial mandibular osteotomy will be performed during bilateral sagittal split ramus osteotomy (BSSO). The medial horizontal osteotomy will be initiated at the lingula and extended posteriorly for a short distance, according to the Hunsuck modification. The remaining steps of the BSSO will be performed using the standard surgical technique. Postoperative skeletal stability and relapse will be assessed using preoperative, immediate postoperative, and follow-up radiographic evaluations

Hunsuck Modification Group

The Posnick modification of the medial mandibular osteotomy will be performed during bilateral sagittal split ramus osteotomy (BSSO). The medial horizontal osteotomy will be performed according to the Posnick modification, with the osteotomy design extending posteriorly along the medial aspect of the mandibular ramus as described for this technique. The remaining steps of the BSSO will be performed using the standard surgical technique. Postoperative skeletal stability and relapse will be assessed using preoperative, immediate postoperative, and follow-up radiographic evaluations.

Posnick Modification Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with an indication for orthognathic surgery who are planned to undergo bimaxillary orthognathic surgery.
  • Patients who have undergone preoperative orthodontic treatment.
  • Patients aged 18-65 years.

You may not qualify if:

  • Patients who develop an unfavorable split (bad split) during surgery.
  • Patients with cleft lip and palate, craniofacial syndromes, or a history of facial trauma.
  • Patients who have previously undergone orthognathic surgery and require revision surgery.
  • Patients whose computed tomography (CT) records are inadequate for the required measurements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem vakif university

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Recurrence

Interventions

Osteotomy, Sagittal Split Ramus

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeOsteotomyOrthopedic ProceduresDentistry

Central Study Contacts

Emine Fulya Akkoyun, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 27, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 28, 2026

Study Completion (Estimated)

April 25, 2027

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations