Trials
Search / Trial NCT06442787

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

Launched by BEZMIALEM VAKIF UNIVERSITY · May 28, 2024

Apply for Trial

Trial Information

Current as of March 13, 2025

Recruiting

Keywords

Virtual Surgical Planning Orthognathic Surgery Custom Plate Mandibular Condyle Position

ClinConnect Summary

This clinical trial is exploring new ways to improve the results of orthognathic surgery, which is a procedure to correct jaw and facial deformities. The researchers want to compare different methods for positioning the lower jaw during surgery to see which one works best. They will use advanced technology, like virtual planning and custom-made tools, to help make the surgery more precise. While there is a lot of information about the upper jaw positioning, there is not enough research on how to best position the lower jaw, which is what this study aims to address.

To participate in this trial, you must be a healthy adult over 18 years old who has been diagnosed with specific types of jaw misalignments (known as skeletal Class 2 and Class 3 malocclusions) and has already received orthodontic treatment. Unfortunately, individuals with certain conditions, such as cleft lip and palate, past jaw injuries, or specific allergies, won't be eligible. If you choose to participate, you can expect to undergo surgery using the latest techniques, and your progress will be carefully monitored. This study could help improve how jaw surgeries are performed in the future, benefiting many patients.

Gender

ALL

Eligibility 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

About Bezmialem Vakif University

Bezmialem Vakif University is a prominent academic institution based in Istanbul, Turkey, dedicated to advancing medical research and education. As a clinical trial sponsor, the university leverages its state-of-the-art facilities and a multidisciplinary team of experts to conduct innovative research that aims to improve patient outcomes and enhance therapeutic strategies. Bezmialem Vakif University is committed to adhering to rigorous ethical standards and regulatory guidelines, ensuring the integrity and reliability of its clinical trials while fostering collaboration with global research communities. Through its initiatives, the university seeks to contribute significantly to the field of medicine and public health.

Locations

Istanbul, Fatih, Turkey

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0