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

Not Applicable

Completed

• Conditions: Abnormalities, Jaw; Malocclusion
• Interventions: Device: 3D Printing Personalized Titanium Plate

• Registration Number: NCT02914431
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Study Timeline

• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-22
• Study First Posted: 2016-09-26
• Study Start: 2017-09-06
• Primary Completion: 2019-01-14
• Study Completion: 2019-04-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D Printing Personalized Titanium Plate	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.

Primary Outcome Measures

Name	Time	Method
Difference of the maxillary position	3 days after the operation	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.

Secondary Outcome Measures

Name	Time	Method
Operative time	Operative day	Time cost of the operation
Intraoperative blood loss	Operative day	Intraoperative blood loss
Translational differences of the maxilla	3 days after the operation	The translation differences of the centroid of the maxilla between the virtual plan and the actual result were calculated in X, Y and Z axis.
Orientational differences of the maxilla	3 days after the operation	The coordinates of all three landmarks of the maxilla was used to calculate the differences of orientation between the plan and postoperative results, which were calculated in pitch (the rotation around the X axis), roll (the rotation around the Y axis), and yaw (the rotation around the Z axis).

Trial Locations

Locations (1)

Ninth People's Hospital, Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China