Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07125963

Patient-Specific vs. Conventional Positioning in Sagittal Split Ramus Osteotomy

Led by Sümer Münevveroğlu · Updated on 2025-08-15

30

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to evaluate the clinical efficacy and positioning accuracy of a custom-made proximal segment positioning appliance designed for use in sagittal split ramus osteotomy (SSRO). The appliance is produced using STL-based digital planning and 3D printing technologies. In each patient, the appliance is applied to one side of the mandible while the contralateral side is positioned using the conventional manual method. This within-subject design enables direct comparison by eliminating inter-individual anatomical variability. The primary outcome is the accuracy of segment positioning, evaluated by 3D superimposition and deviation analysis of pre- and postoperative STL models. Secondary outcomes include surgical time, ease of use as rated by the surgeon, and postoperative temporomandibular joint symptoms. The study will enroll 30 adult patients undergoing SSRO or double-jaw surgery due to dentofacial deformities. The results are expected to provide high-level clinical evidence for the reliability of patient-specific appliances in orthognathic surgery.

CONDITIONS

Official Title

Patient-Specific vs. Conventional Positioning in Sagittal Split Ramus Osteotomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled to undergo bilateral sagittal split ramus osteotomy as part of orthognathic surgery
  • Age 18 years or older
  • Availability of preoperative and postoperative CT scans
  • Consent to participate in the study
Not Eligible

You will not qualify if you...

  • History of previous mandibular surgery
  • Craniofacial syndromes or congenital deformities
  • Incomplete radiological records

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Istanbul Medipol University, Medipol Mega University Hospital

Istanbul, Bağcılar, Turkey (Türkiye), 34218

Actively Recruiting

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Research Team

S

Sümer Münevveroğlu, D.D.S., Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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