Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- History of previous mandibular surgery
- Craniofacial syndromes or congenital deformities
- Incomplete radiological records
AI-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
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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