Accuracy of a CAD/CAM Surgical Template for Mandible Distraction

Facial Asymmetry Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03270618
• Other study ID #: cmfs02
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2017
• Last updated: August 31, 2017
• Start date: January 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2017
• Source: Shanghai 9th People's Hospital
• Contact: Biao Li, Master
• Phone: 15900561183
• Email: benleex[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2018
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	Ninth People's Hospital, Shanghai Jiaotong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 9th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linear differences of the distractor position		within latency period (5-7 days after the surgery)
Primary	angular differences of the distractor vector		within latency period (5-7 days after the surgery)