Clinical trial NCT02914431: Personalized Titanium Plates vs CAD/CAM Surgical Splints in Maxillary Repositioning of Orthognathic Surgery
Official title: A Randomized Controlled Trial of the Accuracy of Maxillary Repositioning Using Personalized Titanium Plates vs CAD/CAM Surgical Splints in Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Abnormalities, Jaw
Keywords: Personalized Titanium Plate
Orthognathic Surgery
Maxilla Repositioning
Accuracy
Computer-aided Design and Manufacturing
Patient Specified Implants (PSI)
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference of the maxillary position
timeFrame: 3 days after the operation
Secondary outcomes:
measure: Intraoperative blood loss
timeFrame: Operative day
measure: Operative time
timeFrame: Operative day
measure: Translational differences of the maxilla
timeFrame: 3 days after the operation
measure: Orientational differences of the maxilla
timeFrame: 3 days after the operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
Study officials:
affiliation: Department of Oral and Craniomaxillofacial Surgery
name: Xudong Wang, MD, PhD
role: STUDY_DIRECTOR
References: