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Accuracy of a CAD/CAM Surgical Template for Mandible Distraction

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CAD/CAM Surgical Template

About this trial

This is an interventional treatment trial for Facial Asymmetry

Eligibility Criteria

6 Years - 60 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Linear differences of the distractor position

angular differences of the distractor vector

Secondary Outcome Measures

Full Information

NCT ID

NCT03270618

First Posted

August 31, 2017

Last Updated

August 31, 2017

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

1. Study Identification

Unique Protocol Identification Number

NCT03270618

Brief Title

Accuracy of a CAD/CAM Surgical Template for Mandible Distraction

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2014 (Actual)

Primary Completion Date

April 30, 2016 (Actual)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

CAD/CAM Surgical Template

Intervention Description

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.

Primary Outcome Measure Information:

Title

Linear differences of the distractor position

Time Frame

within latency period (5-7 days after the surgery)

Title

angular differences of the distractor vector

Time Frame

within latency period (5-7 days after the surgery)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Biao Li, Master

Phone

15900561183

benleex@foxmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xudong Wang

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Biao Li, Master

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Accuracy of a CAD/CAM Surgical Template for Mandible Distraction

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