Accuracy of a CAD/CAM Surgical Template for Mandible Distraction

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03270618

Enrollment

Registered

2017-09-01

Start date

2014-01-01

Completion date

2018-12-31

Last updated

2017-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICECAD/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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
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)

Countries

China

Contacts

Primary ContactBiao Li, Master

benleex@foxmail.com15900561183

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026