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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSümer Münevveroğlu

About this trial

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.

Eligibility criteria

Qualifiers

Patients scheduled to undergo bilateral sagittal split ramus osteotomy as part of orthognathic surgery

Age ≥ 18 years

Availability of preoperative and postoperative CT scans

Consent to participate in the study

Disqualifiers

History of previous mandibular surgery

Craniofacial syndromes or congenital deformities

Incomplete radiological records

Trial design

Treatments tested in this trial

  • Custom-made positioning appliance-assisted mandibular segment repositioning
  • Conventional Manual Positioning

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sümer Münevveroğlu

Lead sponsor

Medipol University

Sponsor institution