Accuracy of a CAD/CAM Surgical Template for Mandible Distraction

NCT03270618 | Unknown

• 1 other identifier: cmfs02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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)

Interventions

CAD/CAM Surgical Template DEVICE

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.

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients requiring more than one distractor of the mandible
• Patients with mandible defect
• Patients with previous mandibular trauma

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Facial Asymmetry; Diastasis, Bone

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Officials

• Xudong Wang

  Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

  STUDY CHAIR

Central Study Contacts

Biao Li, Master

CONTACT

15900561183; benleex@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Oral and Craniomaxillofacial Surgery

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 1, 2017
• Study Start: January 1, 2014
• Primary Completion: April 30, 2016
• Study Completion: December 31, 2018
• Last Updated: September 1, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)