An interventional study of CAD/CAM Surgical Template in Facial Asymmetry, Mandible; Hypoplasia, Unilateral Condylar and Distraction of Bone, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Status unknown at 1 site in China. Open to participants aged 6 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-09-01.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
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)
Plan to share: No
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Diastasis, Bone
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University