Comparison of a Patient-Specific Proximal Segment Positioning Appliance and the Conventional Method in Sagittal Split Ramus Osteotomy

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Istanbul Medipol University, Medipol Mega University Hospital
RECRUITING
Istanbul
Contact Information
Primary
Sümer Münevveroğlu, D.D.S., Ph.D.
sumer.munevveroglu@medipol.edu.tr
00905386013666
Time Frame
Start Date: 2024-01-25
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 30
Treatments
Experimental: Custom-made positioning appliance-assisted mandibular segment repositioning
Patients receive a custom-made positioning appliance designed via STL-based planning and manufactured using 3D printing. The appliance is used to guide the proximal mandibular segment during sagittal split ramus osteotomy on one side of the mandible, aiming to improve positional accuracy.
Active_comparator: Conventional Manual Positioning
On the contralateral side of the mandible, the proximal segment is positioned manually by the surgeon using standard visual and tactile feedback during sagittal split ramus osteotomy, without a guiding appliance.
Related Therapeutic Areas
Sponsors
Leads: Sümer Münevveroğlu

This content was sourced from clinicaltrials.gov