Personalized Titanium Plates vs CAD/CAM Surgical Splints in Maxillary Repositioning of Orthognathic Surgery
Primary Purpose
Malocclusion, Abnormalities, Jaw
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3D Printing Personalized Titanium Plate
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion focused on measuring Personalized Titanium Plate, Orthognathic Surgery, Maxilla Repositioning, Accuracy, Computer-aided Design and Manufacturing, Patient Specified Implants (PSI)
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
Sites / Locations
- Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
3D Printing Personalized Titanium Plate
CAD/CAM Surgical Splint
Arm Description
After the LeFort I osteotomy, the intraoperative repositioning and fixation of the maxilla is accomplished using 3D printing personalized titanium plates.
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.
Outcomes
Primary Outcome Measures
Difference of the maxillary position
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
Intraoperative blood loss
Intraoperative blood loss
Operative time
Time cost of the operation
Translational differences of the maxilla
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
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).
Full Information
NCT ID
NCT02914431
First Posted
September 20, 2016
Last Updated
July 30, 2019
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Study Identification
Unique Protocol Identification Number
NCT02914431
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
January 14, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Abnormalities, Jaw
Keywords
Personalized Titanium Plate, Orthognathic Surgery, Maxilla Repositioning, Accuracy, Computer-aided Design and Manufacturing, Patient Specified Implants (PSI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3D Printing Personalized Titanium Plate
Arm Type
Experimental
Arm Description
After the LeFort I osteotomy, the intraoperative repositioning and fixation of the maxilla is accomplished using 3D printing personalized titanium plates.
Arm Title
CAD/CAM Surgical Splint
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
3D Printing Personalized Titanium Plate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference of the maxillary position
Description
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.
Time Frame
3 days after the operation
Secondary Outcome Measure Information:
Title
Intraoperative blood loss
Description
Intraoperative blood loss
Time Frame
Operative day
Title
Operative time
Description
Time cost of the operation
Time Frame
Operative day
Title
Translational differences of the maxilla
Description
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.
Time Frame
3 days after the operation
Title
Orientational differences of the maxilla
Description
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).
Time Frame
3 days after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xudong Wang, MD, PhD
Organizational Affiliation
Department of Oral and Craniomaxillofacial Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Personalized Titanium Plates vs CAD/CAM Surgical Splints in Maxillary Repositioning of Orthognathic Surgery
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