Using virtual planning and custom guides to improve jaw surgery outcomes
Analysis of Mandibular Proximal Segment Position Using Virtual Orthognathic Surgical Planning, Individualized Guides, and Osteosynthesis Plates
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Bezmialem Vakif University Academic / other |
| Locations | 1 site (Istanbul, Fatih) |
| Trial ID | NCT06442787 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include healthy adults over 18 with skeletal Class 2 or Class 3 malocclusion who require bimaxillary orthognathic surgery.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Istanbul, Fatih
- Bezmialem Vakıf Universty — Istanbul, Fatih, Turkey (Türkiye) (Recruiting)
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.