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

Shanghai Jiao Tong University

Status: Completed

Conditions: Malocclusion; Abnormalities, Jaw

Treatments: Device: 3D Printing Personalized Titanium Plate

Study type: Interventional

Funder types: Other

Identifiers

NCT02914431

20152225

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

3D Printing Personalized Titanium Plate

Experimental group

Description:

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

Treatment:

Device: 3D Printing Personalized Titanium Plate

CAD/CAM Surgical Splint

No Intervention group

Description:

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.