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Clinical Trials/NCT03270618
NCT03270618
Unknown
Not Applicable

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

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 site in 1 country30 target enrollmentJanuary 1, 2014

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2014
End Date
December 31, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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