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

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ClinicalTrials.gov Identifier: NCT02914431
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
wang xu dong, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Condition or disease Intervention/treatment Phase
Malocclusion Abnormalities, Jaw Device: 3D Printing Personalized Titanium Plate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Intraoperative blood loss [ Time Frame: Operative day ]
    Intraoperative blood loss

  2. Operative time [ Time Frame: Operative day ]
    Time cost of the operation

  3. 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.

  4. 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).



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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China, Shanghai
Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
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Study Director: Xudong Wang, MD, PhD Department of Oral and Craniomaxillofacial Surgery
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Responsible Party: wang xu dong, Director of Department of Oral and Craniomaxillofacial Surgery, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT02914431    
Other Study ID Numbers: 20152225
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by wang xu dong, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
Personalized Titanium Plate
Orthognathic Surgery
Maxilla Repositioning
Accuracy
Computer-aided Design and Manufacturing
Patient Specified Implants (PSI)
Additional relevant MeSH terms:
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Jaw Abnormalities
Malocclusion
Congenital Abnormalities
Tooth Diseases
Stomatognathic Diseases
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic System Abnormalities