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Personalized Titanium Plates vs CAD/CAM Surgical Splints in Maxillary Repositioning of Orthognathic Surgery

NCT02914431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-08-01

No results posted yet for this study

Summary

The purpose of this study is to determine whether personalized titanium plates can achieve better accuracy than CAD/CAM surgical splint in maxilla repositioning in orthognathic surgery, and evaluate the feasibility of this technique in clinical application.

Conditions

  • Malocclusion
  • Abnormalities, Jaw

Interventions

DEVICE

3D Printing Personalized Titanium Plate

The cutting guides were placed onto the planned position. The cutting guides also worked as the drilling guide. Several screw holes were drilled using the predetermined screw holes on the guides. The osteotomy / ostectomy then start. Next, the 3D printing personalized maxillary fixation plates were adapted to reposition the Le Fort I segment to the planned position. The screw holes on the bones prepared by the cutting guides were used as the bony reference. The personalized plate was first firmly installed on the maxilla above the osteotomy line by aligning the corresponding screw holes on the plate to the bone. Afterwards, the position of the osteotomized Le Fort I segment was adjusted till all the remaining corresponding screw holes on bone and plate were aligned.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Xudong Wang, MD, PhD · Department of Oral and Craniomaxillofacial Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2019-01-14
Completion
2019-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02914431 on ClinicalTrials.gov