Personalized Titanium Plates vs CAD/CAM Surgical Splints in Maxillary Repositioning of Orthognathic Surgery
Condition: Malocclusion; Abnormalities, Jaw
MeSH terms: Jaw Abnormalities; Malocclusion
Study type: Interventional

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.
    

Intervention name(s): 3D Printing Personalized Titanium Plate
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Personalized Titanium Plate; Orthognathic Surgery; Maxilla Repositioning; Accuracy; Computer-aided Design and Manufacturing; Patient Specified Implants (PSI)