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A 3D Analysis of Mandibular Plating Strategies in Oromandibular Reconstruction.

A 3D Analysis of Mandibular Plating Strategies in Oromandibular Reconstruction: A Single- Blinded Randomized Controlled Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03550053
Acronym
3Dplating
Enrollment
20
Registered
2018-06-08
Start date
2017-03-16
Completion date
2019-12-31
Last updated
2020-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Brief summary

Reconstruction of the mandible commonly employs the use of metal plates to provide a framework for placement of bone grafts. The standard approach to reconstruction involves bending these plates to the mandible intraoperatively. A novel technique involves bending plates to three dimensional (3D) printed models of the mandible prior to surgery. No study has performed a quantitative analysis and comparison of these two different strategies. The purpose of this study is to compare reconstructive plating strategies (preoperative versus intraoperative bending) for mandibular reconstruction using 3D quantitative analysis. Preoperative diagnostic CT scans of the head/neck of 20 patients scheduled to undergo mandibular reconstruction will be obtained and imported into 3D modeling software. A computer based 3D reconstructed mandible will be printed. Simulated reconstruction will be replicated by contouring mandibular reconstruction plates to each model. The plates will be marked, sterilized and brought to the operating room on the day of surgery. Each patient will be randomized to either preoperative (n=10) or intraoperative (n=10) plate bending groups. The group will be revealed to the primary surgeon on the day of surgery and the patient will either be fit with the plate bent preoperatively or will undergo fitting with a plate bent intraoperatively. Following reconstruction of the mandible, the patient will undergo intraoperative cone beam scanning. Using scans performed pre- and post-mandibular reconstruction, the 3D simulated mandibles will be compared based on the position of the mandibular condyle within the Temporomandibular Joint. In addition, the percentage of surface area contact between the plate and mandible and the postoperative occlusion attained will be determined and compared between groups. It is expected that the preformed plates will have improved contact surface area, and better achieve pre-reconstruction occlusion when compared to plates bent intraoperatively.

Detailed description

Patients will be identified through attendance at the Wharton Head and Neck Clinic at Princess Margaret Hospital or attendance at the Toronto General Hospital Otolaryngology - Head & Neck Surgery clinic as requiring resection of mandibular pathology and subsequent reconstruction with bony free flap. Chart review (electronic) of these patients will be performed to obtain demographic information and factors such as tumor type, site, stage and prior treatment. Data will be obtained from CT scans to create 3D models, including anatomic parameters required for 3D printing of the mandible. Following reconstruction, a number of variables will be collected (i.e. position of the mandibular condyle within the temporomandibular joint, percentage of surface area contact between the plate and bone, type of occlusion/bite and degree of conformance). All of this data will be stored in a password protected Excel spreadsheet located on a secure University Health Network computer. Twenty participants will be enrolled into this study and randomized to one of two groups: intraoperative plate bending (n=10) or preoperative plate bending (n=10) using a 3D printed model. While the participant can be blinded to the strategy that will be pursued, the surgeon performing the reconstruction will not be blinded.

Interventions

DEVICE3D mandibular plate

Patients will be randomly assigned to either have the mandibular plate bent before their surgery, using a 3D model of their mandible or have the mandibular plate bent during their surgery, which is standard of care.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Masking description

Patient will not know which group they are randomized to.

Intervention model description

Patients with head and neck cancer, specifically requiring surgery to their mandible.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing planned resection with osseous free flap reconstruction of the mandible * Pathology limited to unilateral involvement of the mandible from the angle to the mandibular symphysis (lateral defects)

Exclusion criteria

* Patients under age 18 * Prior reconstruction of the mandible

Design outcomes

Primary

MeasureTime frameDescription
Change in Jaw contour1 week after surgeryContour of the mandible will be measured using the pre and post-op CT images. A comparison will be made between the sets of images to determine which strategy of reconstruction (pre-bent plate or intraoperative bent plate) better recreates the native contours of the mandible.

Secondary

MeasureTime frameDescription
Change in Jaw occlusion1 week after surgeryOcclusion of the mandible will be measure using the pre and post-op CT images. A comparison will be made between the sets of images to determine which strategy of reconstruction (pre-bent plate or intraoperative bent plate) better recreates the natural bite/occlusion.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026