Clinical trial Recruiting at 1 site Interventional Ages 18 to 55

Using virtual planning and custom guides to improve jaw surgery outcomes

Official title: Analysis of Mandibular Proximal Segment Position Using Virtual Orthognathic Surgical Planning, Individualized Guides, and Osteosynthesis Plates

Run by Bezmialem Vakif University · NCT06442787 · Data updated 2026-11-12

This study is testing if using virtual planning and custom tools can help improve the results of jaw surgery for adults with specific jaw alignment issues.

Quick facts

Study typeInterventional
Ages18 Years to 55 Years
SexAll
Enrollment60 (estimated)
SponsorBezmialem Vakif University
Academic / other
Locations1 site (Istanbul, Fatih)
StatusRecruiting
StartedOctober 1, 2024
Main results expectedMarch 1, 2025
Study endsMarch 1, 2025
Registry record updatedJanuary 28, 2025
Trial IDNCT06442787 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include healthy adults over 18 with skeletal Class 2 or Class 3 malocclusion who require bimaxillary orthognathic surgery.

Probably not a fit

Patients with cleft lip and palate, craniofacial deformities, or those with a history of temporomandibular joint disorders may not benefit from this study.

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

What this trial studies

This study focuses on enhancing the precision of orthognathic surgery through the use of virtual surgical planning, individualized cutting guides, and patient-specific osteosynthesis plates. It aims to compare the effectiveness of various proximal segment positioning devices in mandibular surgeries, addressing the common issue of incorrect positioning that can lead to complications. By analyzing the outcomes of these innovative techniques, the study seeks to provide insights into improving surgical results for patients with dentofacial deformities. The research will involve healthy adults with specific skeletal malocclusions who have undergone orthodontic treatment prior to surgery.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate jaw positioning during surgery, reducing complications and improving patient outcomes.

How similar studies have gone: While there have been successful reports on the use of patient-specific plates in maxillary positioning, this study is novel in its focus on mandibular positioning.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Healthy individuals over 18 years of age
2. Patients with skeletal Class 2 and Class 3 malocclusion requiring bimaxillary orthognathic surgery
3. Patients who have undergone orthodontic treatment prior to surgery

Exclusion Criteria:

1. Patients with cleft lip and palate or craniofacial deformities
2. Oligodontia
3. Patients in whom the study protocol could not be continued due to intraoperative complications such as guide mismatch or bad split, or due to reasons such as inability to obtain postoperative CT scans
4. Patients with pre-existing temporomandibular joint disorders prior to surgery
5. Patients who have undergone previous orthognathic surgery
6. Patients with a history of maxillary or mandibular trauma
7. Patients requiring segmental maxillary surgery
8. Patients with bone metabolism disorders
9. Patients allergic to titanium
10. Pregnant individuals

Where it's running

  • Bezmialem Vakıf Universty
    Istanbul, Fatih, Turkey (Türkiye)
    Recruiting

Similar studies

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.