Custom 3D-printed guide versus manual positioning for the proximal mandibular segment in sagittal split ramus osteotomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.