Head and Neck Cancer3DplatingNCT03550053
A 3D Analysis of Mandibular Plating Strategies in Oromandibular Reconstruction.
A study testing 3D mandibular plate in people with Head and Neck Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- 3D mandibular plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 16 Mar 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients under age 18
- Prior reconstruction of the mandible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 3D Analysis of Mandibular Plating Strategies in Oromandibular Reconstruction: A Single- Blinded Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- 3D mandibular plate
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D mandibular plateDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative plate bending | Active comparator | Plate will be bent intraoperatively, which is the standard of care, for this surgery Receives: Device: 3D mandibular plate |
| Preoperative plate bending | Active comparator | A 3D printed model of the patient's mandible will be used to bend the plate preoperatively by the surgeon. The pre-bent plate will be brought into the operating room on the day of surgery. Receives: Device: 3D mandibular plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Jaw contour
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.
Measured: 1 week after surgery
Secondary outcomes (1)
Change in Jaw occlusion
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.
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start16 Mar 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with head and neck cancer, specifically requiring surgery to their mandible.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550053
- Sponsor's protocol ID
- 16-5984
- Acronym
- 3Dplating
- Status last verified
- Dec 2020
- First submitted
- 14 Nov 2017
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3D Analysis of Mandibular Plating Strategies in Oromandibular Reconstruction: A Single- Blinded Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03550053
- Acronym / sponsor ID
- 3Dplating / 16-5984
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients with head and neck cancer, specifically requiring surgery to their mandible.
| Arm | Type | Receives |
|---|---|---|
| Intraoperative plate bending | Active comparator | Device: 3D mandibular platePlate will be bent intraoperatively, which is the standard of care, for this surgery |
| Preoperative plate bending | Active comparator | Device: 3D mandibular plateA 3D printed model of the patient's mandible will be used to bend the plate preoperatively by the surgeon. The pre-bent plate will be brought into the operating room on the day of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Patients under age 18
- Prior reconstruction of the mandible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D mandibular platePatients 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. | Device | Intraoperative plate bending, Preoperative plate bending |
Primary outcome
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.
1 secondary outcome
Change in Jaw occlusion
Time frame: 1 week after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D mandibular plate in people with Head and Neck Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Jaw contour (time frame: 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.