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Accuracy of a CAD/CAM Surgical Template for Mandible Distraction

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Mandible; Hypoplasia, Unilateral Condylar
Distraction of Bone
Facial Asymmetry

Treatments

Device: CAD/CAM Surgical Template

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

6 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Biao Li, Master

Data sourced from clinicaltrials.gov

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