Accuracy of a CAD/CAM Surgical Template for Mandible Distraction

Not Applicable

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

• Registration Number: NCT03270618
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2016-04-30
• Status Verified: 2017-08
• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-08-31
• Last Update Submitted: 2017-08-31
• Study First Posted: 2017-09-01
• Last Update Posted: 2017-09-01
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Linear differences of the distractor position	within latency period (5-7 days after the surgery)
angular differences of the distractor vector	within latency period (5-7 days after the surgery)

Trial Locations

Locations (1)

Ninth People's Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China