Maxillofacial InjuriesNCT03369366
Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects
A study testing NobelActive and KLS Martin Mandibular Reconstruction Implant in people with Maxillofacial Injuries, run by University of Florida.
Trial summary
Immediate reconstruction and dental rehabilitation of maxillofacial ablative defects with patient specific reconstruction plates, dental implants, and immediate load provisional screw-retained prosthesis will improve patient short and long term outcomes and improve patient quality of life. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Maxillofacial Injuries
- What is being tested?
- NobelActive and KLS Martin Mandibular Reconstruction Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Jun 2021
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and Female patients between 16 and 60 years of age
- Patients with benign, large tumors requiring surgical resection with free tissue transfer reconstruction involving the maxilla and mandible will be included in the study.
Who cannot join
- Patients below the age of 16 years and over the age of 60 years
- Patients with malignant tumors
- Patients with contraindications for surgical intervention and/or free tissue transfer
- Patients actively participating in another investigational clinical study and who, in the Investigator's or opinion, should not be enrolled in this study.
About this study
Immediate reconstruction and dental rehabilitation of maxillofacial ablative defects with patient specific reconstruction plates, dental implants, and immediate load provisional screw-retained prosthesis will improve patient short and long term outcomes and improve patient quality of life. Utilizing current technologic advances, patients undergoing large ablative procedures for benign head and neck pathology can now not only have immediate bone and soft tissue reconstruction, but dental rehabilitation as well. Using virtual surgical planning, patient specific selective laser melded reconstruction plates, and dental implants, a screw-retained provisional dental restoration can be fabricated and placed during a one-stage procedure with minimal to no intra-operative prosthetic work required.
Read the detailed description
The primary goal of any reconstructive procedure is to restore a patient's natural form and function. The new techniques implemented in this study will demonstrate an approach that allows immediate return of the patient's premorbid state in one procedure. The investigators have demonstrated success with a small cohort of patients, and published a recent case study regarding this new technique. This study is meant to build upon the investigators experiences and advance their process and treatment of these patients. With a larger patient population to study, greater data can be obtained, with the ultimate goal of establishing this treatment as a new standard of care for patients with large ablative defects requiring reconstruction.
Patients with benign, large tumors requiring surgical resection with free tissue transfer reconstruction involving the maxilla and mandible will be included in the study. All of the patients will undergo the following pre-operative protocol:
- CT Maxillofacial Region
- CTA
- Dental impression (intra-oral scan and/or impressions)
- Virtual surgical planning
- Patient specific plate fabrication
- Resection and flap harvest osteotomy guides
- Fabrication of screw-retained provisional prosthesis
Surgical treatment protocol involves:
- Resection of benign tumor using osteotomy guides
- Reconstruction with free tissue (osseous free flap) transfer using osteotomy guides
- Placement of dental implants (minimum of three) using integrated osteotomy and implant placement guide
- Placement of provisional screw-retained prosthesis (all while flap is still pedicled to vascular supply)
- Inset of flap/implant/prosthesis/custom plate construct
- Vascular anastomosis and closure
Immediate post-operative management will include a 5-to-7 day post-operative hospital stay and a post-operative CT scan evaluation. Long-term evaluation of patients will include routine clinical exams and cone beam CT scans to evaluate flap and implant survival. Patients, for the purpose of this study, will be followed for one year following placement of final dental prosthesis (18-24 months post-operatively).
- Conditions
- Maxillofacial Injuries
- Being tested
- NobelActive, KLS Martin Mandibular Reconstruction Implant
- Keywords
- Maxillofacial Defects, Benign, large tumors requiring surgical resection
- Medical subject headings
- Maxillofacial Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NobelActiveDevice
NobelActive's expanding tapered implant body condenses bone gradually while the apex with drilling blades enables a smaller osteotomy. These features help to achieve high primary stability in demanding situations, such as soft bone or extraction sockets. NobelActive enables immediate implant placement and Immediate Function where it might otherwise be challenging.
KLS Martin Mandibular Reconstruction ImplantDevice
The prefabricated prosthesis will be secured onto the implants using non-engaging multiunit abutments with screws, followed by fixation of the patient-specific plate to the fibula with monocortical screws. The previously used cutting guides are fixated with the screw locations corresponding to the screw locations of the custom plate. This allows for accurate positioning and fixation of the custom construct of the plate and fibula without the need for intermaxillary fixation (IMF).
| Study group | Role | What they receive |
|---|---|---|
| Reconstruction and Dental Rehabilitation | Experimental | Placement of NobelActive dental implants (minimum of three) using integrated osteotomy and implant placement guide.Placement of provisional screw-retained prosthesis (all while flap is still pedicled to vascular supply). Inset of flap/implant/prosthesis/custom plate construct (KLS Martin Mandibular Reconstruction Implant). Receives: Device: NobelActive; Device: KLS Martin Mandibular Reconstruction Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to final dental rehabilitation
Time elapsed until final dental rehabilitation is reached.
Measured: 6-8 months
Secondary outcomes (4)
Total operating room time
The total time taken in operating room for a procedure
Measured: 6-8 hours
Surgical outcome accuracy (CT imaging)
Accuracy of the proposed surgical outcome assessed via CT scan imaging
Measured: 5-10 days post-op
Implant survival - Short term
Six month survival rate of the dental implant
Measured: 6 months post operatively
Implant survival - Long term
Long term survival rate of the dental implant
Measured: one year post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study startJul 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: Funding not received.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial InjuriesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rui P Fernandes, MD, DMD, Principal investigator, Associate Professor; Associate Chair; Chief, Division of Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369366
- Sponsor's protocol ID
- IRB201702812
- Status last verified
- Jul 2019
- First submitted
- 6 Dec 2017
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made available to researchers outside of the study.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects
- ClinicalTrials.gov ID
- NCT03369366
- Acronym / sponsor ID
- IRB201702812
- Conditions
- Maxillofacial Injuries
- Keywords
- Maxillofacial Defects, Benign, large tumors requiring surgical resection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not received.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 12 Dec 2017 (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.
Immediate reconstruction and dental rehabilitation of maxillofacial ablative defects with patient specific reconstruction plates, dental implants, and immediate load provisional screw-retained prosthesis will improve patient short and long term outcomes and improve patient quality of life. Utilizing current technologic advances, patients undergoing large ablative procedures for benign head and neck pathology can now not only have immediate bone and soft tissue reconstruction, but dental rehabilitation as well. Using virtual surgical planning, patient specific selective laser melded reconstruction plates, and dental implants, a screw-retained provisional dental restoration can be fabricated and placed during a one-stage procedure with minimal to no intra-operative prosthetic work required.
Detailed description
The primary goal of any reconstructive procedure is to restore a patient's natural form and function. The new techniques implemented in this study will demonstrate an approach that allows immediate return of the patient's premorbid state in one procedure. The investigators have demonstrated success with a small cohort of patients, and published a recent case study regarding this new technique. This study is meant to build upon the investigators experiences and advance their process and treatment of these patients. With a larger patient population to study, greater data can be obtained, with the ultimate goal of establishing this treatment as a new standard of care for patients with large ablative defects requiring reconstruction.
Patients with benign, large tumors requiring surgical resection with free tissue transfer reconstruction involving the maxilla and mandible will be included in the study. All of the patients will undergo the following pre-operative protocol:
- CT Maxillofacial Region
- CTA
- Dental impression (intra-oral scan and/or impressions)
- Virtual surgical planning
- Patient specific plate fabrication
- Resection and flap harvest osteotomy guides
- Fabrication of screw-retained provisional prosthesis
Surgical treatment protocol involves:
- Resection of benign tumor using osteotomy guides
- Reconstruction with free tissue (osseous free flap) transfer using osteotomy guides
- Placement of dental implants (minimum of three) using integrated osteotomy and implant placement guide
- Placement of provisional screw-retained prosthesis (all while flap is still pedicled to vascular supply)
- Inset of flap/implant/prosthesis/custom plate construct
- Vascular anastomosis and closure
Immediate post-operative management will include a 5-to-7 day post-operative hospital stay and a post-operative CT scan evaluation. Long-term evaluation of patients will include routine clinical exams and cone beam CT scans to evaluate flap and implant survival. Patients, for the purpose of this study, will be followed for one year following placement of final dental prosthesis (18-24 months post-operatively).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reconstruction and Dental Rehabilitation | Experimental | Device: NobelActive, Device: KLS Martin Mandibular Reconstruction ImplantPlacement of NobelActive dental implants (minimum of three) using integrated osteotomy and implant placement guide.Placement of provisional screw-retained prosthesis (all while flap is still pedicled to vascular supply). Inset of flap/implant/prosthesis/custom plate construct (KLS Martin Mandibular Reconstruction Implant). |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Male and Female patients between 16 and 60 years of age
- Patients with benign, large tumors requiring surgical resection with free tissue transfer reconstruction involving the maxilla and mandible will be included in the study.
Key exclusion criteria (4 listed)
- Patients below the age of 16 years and over the age of 60 years
- Patients with malignant tumors
- Patients with contraindications for surgical intervention and/or free tissue transfer
- Patients actively participating in another investigational clinical study and who, in the Investigator's or opinion, should not be enrolled in this study.
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 |
|---|---|---|
| NobelActiveNobelActive's expanding tapered implant body condenses bone gradually while the apex with drilling blades enables a smaller osteotomy. These features help to achieve high primary stability in demanding situations, such as soft bone or extraction sockets. NobelActive enables immediate implant placement and Immediate Function where it might otherwise be challenging. | Device | Reconstruction and Dental Rehabilitation |
| KLS Martin Mandibular Reconstruction ImplantThe prefabricated prosthesis will be secured onto the implants using non-engaging multiunit abutments with screws, followed by fixation of the patient-specific plate to the fibula with monocortical screws. The previously used cutting guides are fixated with the screw locations corresponding to the screw locations of the custom plate. This allows for accurate positioning and fixation of the custom construct of the plate and fibula without the need for intermaxillary fixation (IMF). | Device | Reconstruction and Dental Rehabilitation |
Primary outcome
Time to final dental rehabilitation
Time frame: 6-8 months
Time elapsed until final dental rehabilitation is reached.
4 secondary outcomes
Total operating room time
Time frame: 6-8 hours
Surgical outcome accuracy (CT imaging)
Time frame: 5-10 days post-op
Implant survival - Short term
Time frame: 6 months post operatively
Implant survival - Long term
Time frame: one year post operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Individual participant dataSharing planned: No. IPD will not be made available to researchers outside of the study.
Related trials for Maxillofacial Injuries
Enrolling by invitation
Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fracture
Zygomaticomaxillary Complex Fracture, Zygoma Fracture
Recruiting
Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates
Mandibular Fractures
Not yet recruiting
Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections
Infection, Surgical Site
Active, not recruiting
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
Mandible Fracture, Force Measurement
Recruiting
Comparing Pre-adaptation of In-stock Mesh Over In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture With and Without Intraoperative Navigation vs Conventional Intraoperative Free-hand Mesh Bending
Orbital Fractures, Unilateral
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.
Rui P Fernandes, MD, DMD principal investigator
Associate Professor; Associate Chair; Chief, Division of Head and Neck Surgery
Questions about this trial
What is this clinical trial studying?
A study testing NobelActive and KLS Martin Mandibular Reconstruction Implant in people with Maxillofacial Injuries, run by University of Florida.
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 4 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: withdrawn, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Time to final dental rehabilitation (time frame: 6-8 months). 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 17 Jul 2019.