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Completed

NCT Number: NCT03550053

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D mandibular plate

Device

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.

Primary outcomes

  1. Change in Jaw contour

    Time frame: 1 week after surgery

    Contour 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 outcomes

  1. Change in Jaw occlusion

    Time frame: 1 week after surgery

    Occlusion 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: 3Dplating

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2018
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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