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

NCT ID: NCT02914431

Last Updated: 2019-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-06
• Study Completion Date: 2019-04-30

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.

Detailed Description

The repositioning of maxillary segment is essential for esthetic and functional outcomes in orthognathic surgery. With the giant leap in three-dimensional (3D) computer-aided surgical simulation (CASS) technology development, surgeons are now able to simulate various surgical plans in a computer to achieve the best possible outcome. In order to transfer the virtual surgical plan to the patient at the time of the surgery, surgical splints manufactured by computer-aided design and manufacturing (CAD/CAM) technique has been traditionally used to intraoperative reposition the maxilla. Nonetheless, the position of maxilla is still dependent to mandibular autorotation. The instability of the mandibular condyle-fossa relationship is a potential problem that may directly affect the placement of the maxillary segment at the desired position. Personalized titanium plates manufactured using titanium 3D printing technique have been used for maxilla repositioning and fixation to improve the operative accuracy in orthognathic surgery. Despite this, the evidence for advantage of this personalized titanium plates technique is not very strong and based on only a few studies.

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. The accuracy of using both methods for maxilla repositioning was quantitatively evaluated using linear and angular measurement. Secondary outcomes include operative time, amount of intraoperative blood loss, preoperative preparation time and treatment cost will also be measured to evaluate the feasibility of clinical application of personalized titanium plates technique in orthognathic surgery.

Conditions

Malocclusion; Abnormalities, Jaw

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3D Printing Personalized Titanium Plate

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

Group Type: EXPERIMENTAL

3D Printing Personalized Titanium Plate

Intervention Type: 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.

CAD/CAM Surgical Splint

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

wang xu dong

Director of Department of Oral and Craniomaxillofacial Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xudong Wang, MD, PhD

Role: STUDY_DIRECTOR

Department of Oral and Craniomaxillofacial Surgery

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

20152225

Identifier Type: -

Identifier Source: org_study_id