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

NCT02914431 | Completed DMC

• 1 other identifier: 20152225
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Personalized Titanium Plate; Orthognathic Surgery; Maxilla Repositioning; Accuracy; Computer-aided Design and Manufacturing; Patient Specified Implants (PSI)

Outcome Measures

Primary Outcomes (1)

• Difference of the maxillary position

  Three landmark points (Upper dental midline between the 2 maxillary central incisal embrasure and both side mesiobuccal cusp of the upper 1st molar) were adopted on the maxilla, and the coordinates of these three landmarks were used to calculate the centroid of the maxilla. Positional differences of the centroid of the maxilla between the virtual plan and the actual result were measured.

  3 days after the operation

Secondary Outcomes (4)

• Intraoperative blood loss

  Operative day

• Operative time

  Operative day

• Translational differences of the maxilla

  3 days after the operation

• Orientational differences of the maxilla

  3 days after the operation

Study Arms (2)

3D Printing Personalized Titanium Plate

EXPERIMENTAL

After the LeFort I osteotomy, the intraoperative repositioning and fixation of the maxilla is accomplished using 3D printing personalized titanium plates.

Device: 3D Printing Personalized Titanium Plate

CAD/CAM Surgical Splint

NO INTERVENTION

After the LeFort I osteotomy, the intraoperative repositioning of the maxilla is accomplished using CAD/CAM surgical splints and the fixation of the maxilla is accomplished using commercialization titanium plates.

Interventions

3D Printing Personalized Titanium Plate DEVICE

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.

3D Printing Personalized Titanium Plate

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients who were diagnosed with skeletal dentofacial deformity and scheduled to undergo orthognathic surgery including maxillary surgery
• patients who were scheduled to undergo a computed tomography (CT) scan as a part of their diagnosis and treatment
• patients who agreed to participate in this study

You may not qualify if:

• Patients who had the previous orthognathic surgery
• Patients who had the previous maxillary or mandibular trauma
• Patients who had the maxillofacial tumor
• Patients who required the segmental maxillary surgery
• Oral soft tissues defect
• Within the infection period
• Craniofacial syndromes
• Bone metabolism disturbance
• Allergic to the titanium implant
• Unable to give informed consent
• Psychiatric disorders including dementia that may interfere with the study protocol
• Pregnancy
• Included in other studies
• Severe craniomandibular disorders

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, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Malocclusion; Jaw Abnormalities

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Xudong Wang, MD, PhD

  Department of Oral and Craniomaxillofacial Surgery

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 26, 2016
• Study Start: September 6, 2017
• Primary Completion: January 14, 2019
• Study Completion: April 30, 2019
• Last Updated: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)