Actively Recruiting
Analysis of Mandibular Proximal Segment Position Using Virtual Orthognathic Surgical Planning, Individualized Guides, and Osteosynthesis Plates
Led by Bezmialem Vakif University · Updated on 2025-01-28
60
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating different methods to improve the accuracy of mandibular positioning during orthognathic surgery, which corrects dentofacial deformities. This study focuses on comparing conventional splints, patient-specific cutting and positioning guides, and patient-specific fixation plates. The goal is to determine the best approach to reduce errors in positioning the mandibular proximal segment and to understand how these methods affect condylar changes after surgery. The study involves three groups of participants undergoing bilateral sagittal split osteotomy. One group uses only conventional intermediate and final splints during surgery. The second group uses patient-specific cutting and positioning guides, while the third group uses patient-specific cutting guides and fixation plates. These patient-specific devices are designed using virtual surgical planning to precisely transfer the surgical plan to the operation. The trial compares the accuracy and outcomes of these approaches. Participants will be assessed for mandibular condyle changes within the first week after surgery, which is the primary outcome measure. The accuracy of virtual surgical planning will also be evaluated as a secondary outcome during this period. The study includes healthy adults aged 18 to 55 with skeletal Class 2 or Class 3 malocclusion who have completed orthodontic treatment. Data collection includes postoperative CT scans and monitoring for complications. The total involvement includes surgery and immediate postoperative assessment.
CONDITIONS
Brief Title
Analysis of Mandibular Proximal Segment Position Using Virtual Orthognathic Surgical Planning, Individualized Guides, and Osteosynthesis Plates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy individuals over 18 years of age
- Patients with skeletal Class 2 and Class 3 malocclusion requiring bimaxillary orthognathic surgery
- Patients who have undergone orthodontic treatment prior to surgery
You will not qualify if you...
- Patients with cleft lip and palate or craniofacial deformities
- Oligodontia
- Patients unable to continue study due to intraoperative complications or missing postoperative CT scans
- Patients with pre-existing temporomandibular joint disorders
- Patients with previous orthognathic surgery
- Patients with a history of maxillary or mandibular trauma
- Patients requiring segmental maxillary surgery
- Patients with bone metabolism disorders
- Patients allergic to titanium
- Pregnant individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and the first week after surgery
Participants undergo orthognathic surgery using either conventional splints, patient-specific cutting and positioning guides, or patient-specific cutting guides and fixation plates to correct dentofacial deformities.
1 surgical visit and approximately 1 week of post-operative monitoring visits
Duration - 1 week
Participants are monitored for mandibular condyle changes and to assess the accuracy of the virtual surgical planning during the first week after surgery.
Multiple visits in the first week after surgery
Trial Site Locations
Total: 1 location
1
Bezmialem Vakıf Universty
Istanbul, Fatih, Turkey (Türkiye), 34093
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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