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.
27 studies on the registry are indexed under Facial Asymmetry; 10 are open to participants now.
This study's planned enrollment of 30 is below the median of 34 across 17 interventional studies indexed under Facial Asymmetry.
Browse Facial Asymmetry studies →Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 164 studies on the registry; 73 are open to participants now.
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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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Ran from Jan 2014 to primary completion in Apr 2016, 27 months.
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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University →