Personalized Titanium Plates vs CAD/CAM Surgical Splints in Maxillary Repositioning of Orthognathic Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02914431|
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : August 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malocclusion Abnormalities, Jaw||Device: 3D Printing Personalized Titanium Plate||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of the Accuracy of Maxillary Repositioning Using Personalized Titanium Plates vs CAD/CAM Surgical Splints in Orthognathic Surgery|
|Actual Study Start Date :||September 6, 2017|
|Actual Primary Completion Date :||January 14, 2019|
|Actual Study Completion Date :||April 30, 2019|
Experimental: 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.
Device: 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.
No Intervention: 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.
- Difference of the maxillary position [ Time Frame: 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.
- Intraoperative blood loss [ Time Frame: Operative day ]Intraoperative blood loss
- Operative time [ Time Frame: Operative day ]Time cost of the operation
- Translational differences of the maxilla [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914431
|Ninth People's Hospital, Shanghai JiaoTong University School of Medicine|
|Shanghai, Shanghai, China, 200011|
|Study Director:||Xudong Wang, MD, PhD||Department of Oral and Craniomaxillofacial Surgery|