NCT03270618

Accuracy of a CAD/CAM Surgical Template for Mandible Distraction

Accuracy Evaluation of A CAD/CAM Surgical Template for Mandible Distraction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 6 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Facial Asymmetry
• Mandible; Hypoplasia, Unilateral Condylar
• Distraction of Bone

Interventions

Type	Name	Description
DEVICE	CAD/CAM Surgical Template	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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-04-30
• Completion: 2018-12-31
• First posted: 2017-09-01
• Last updated: 2017-09-01

Locations

1 site across 1 country: China