Custom 3D-printed guide versus manual positioning for the proximal mandibular segment in sagittal split ramus osteotomy
Comparison of a Patient-Specific Proximal Segment Positioning Appliance and the Conventional Method in Sagittal Split Ramus Osteotomy
This study will try a custom 3D-printed positioning guide on one side of the jaw and the surgeon's usual manual positioning on the other side in adults having sagittal split ramus osteotomy to see if the guide improves positioning accuracy and short-term outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medipol University Academic / other |
| Locations | 1 site (Istanbul, Bağcılar) |
| Trial ID | NCT07125963 on ClinicalTrials.gov |
What this trial studies
Thirty adults undergoing bilateral SSRO (with or without Le Fort I) will receive a patient-specific proximal segment positioning appliance designed from preoperative CT (STL-based planning using Blender) and printed in biocompatible resin. During surgery the custom guide will be applied to one mandibular side while the opposite side is positioned conventionally, enabling within-patient comparison to remove inter-individual anatomical variability. The primary outcome is positioning accuracy measured by 3D superimposition and deviation analysis of preoperative plans and one-month postoperative STL models from CBCT, with secondary outcomes including surgical time, surgeon-rated ease of use, and postoperative TMJ symptoms. Paired statistical tests (paired t-test or Wilcoxon signed-rank) will compare deviations and clinical measures between guided and manual sides.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for bilateral sagittal split ramus osteotomy for dentofacial deformities who can complete pre- and postoperative CT imaging and provide informed consent.
Not a fit: Patients with prior mandibular surgery, craniofacial syndromes or congenital deformities, or incomplete radiological records are excluded and unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the patient-specific guide could improve proximal segment positioning, potentially reducing TMJ problems, facial asymmetry, and instability after surgery.
How similar studies have performed: 3D planning and patient-specific guides have shown improved accuracy in other orthognathic procedures, but direct within-patient comparisons for proximal segment positioning are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * History of previous mandibular surgery * Craniofacial syndromes or congenital deformities * Incomplete radiological records
Where this trial is running
Istanbul, Bağcılar
- Istanbul Medipol University, Medipol Mega University Hospital — Istanbul, Bağcılar, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Sümer Münevveroğlu, D.D.S., Ph.D.
- Email: sumer.munevveroglu@medipol.edu.tr
- Phone: 00905386013666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.