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

ConditionDentofacial Deformities

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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

Custom-made positioning appliance-assisted mandibular segment repositioning
Procedure/Surgery
A patient-specific surgical guide designed using STL-based digital planning in Blender and produced via 3D printing with biocompatible surgical resin (Formlabs SLA printer). Used to guide and stabilize the proximal mandibular segment during sagittal split ramus osteotomy.
Conventional Manual Positioning
Procedure/Surgery
The proximal mandibular segment is positioned manually by the surgeon based on visual and tactile feedback without the use of a positioning guide. This technique represents the standard method in sagittal split ramus osteotomy.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Custom-made positioning appliance-assisted mandibular segment repositioningExperimental treatment 1 intervention

Group B: Conventional Manual PositioningActive comparator 1 intervention

Trial outcomes

Primary outcomes

Deviation of the proximal mandibular segment from the preoperative plan

The deviation between the actual postoperative position of the proximal mandibular segment and the virtually planned position will be measured in millimeters using superimposed STL files in MeshLab software. The mean deviation value will be compared between the custom-made positioning appliance-assisted method and conventional manual positioning to assess positional accuracy.

Time frame

1 Month Postoperatively

Secondary outcomes

Duration of Fixation After Split

The time required for fixation of the mandibular segments following sagittal split osteotomy will be recorded separately for each side. This period begins immediately after the osteotomy is completed and ends when rigid fixation is achieved. The recorded times will be compared between the custom-made positioning appliance-assisted method and the conventional manual method to evaluate potential differences in procedural efficiency.

Time frame

Intraoperative

Sponsors and contacts

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Sümer Münevveroğlu

Lead sponsor

Medipol University

Sponsor institution

Source ClinicalTrials.gov

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