Accuracy Evaluation of A CAD/CAM Surgical Template for Mandible Distraction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Facial Asymmetry
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Linear differences of the distractor position
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose was to assess the accuracy and clinical validation of virtual planning and surgical template in mandible distraction osteogenesis. Patients with hemifacial microsomia were enrolled. Virtual planning and simulation were performed on three-dimensional models. Distraction was simulated on virtual model and the new morphology of the mandible was predicted. The position and direction of the distractor was determined to achieve the optimal morphology. The templates were designed based on virtual planning and manufactured using three-dimensional printing technique. The template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position. The outcome evaluation was completed by comparing planned outcomes with postoperative outcomes. Linear and angular differences for the distractor was measured.
Investigators
Xudong Wang
Director of the Department of Oral and Craniomaxillofacial Surgery
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Eligibility Criteria
Inclusion Criteria
- •Patients who were scheduled to undergo mandibular DO via intraoral approach
- •Patients who were scheduled to undergo CT scan as a part of their diagnosis and treatment
- •Patients who agreed to participate in this study
Exclusion Criteria
- •Patients requiring more than one distractor of the mandible
- •Patients with mandible defect
- •Patients with previous mandibular trauma
Outcomes
Primary Outcomes
Linear differences of the distractor position
Time Frame: within latency period (5-7 days after the surgery)
angular differences of the distractor vector
Time Frame: within latency period (5-7 days after the surgery)