Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects
Primary Purpose
Maxillofacial Injuries
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NobelActive
KLS Martin Mandibular Reconstruction Implant
Sponsored by
About this trial
This is an interventional treatment trial for Maxillofacial Injuries focused on measuring Maxillofacial Defects, Benign, large tumors requiring surgical resection
Eligibility Criteria
Inclusion and Exclusion Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Reconstruction and Dental Rehabilitation
Arm Description
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).
Outcomes
Primary Outcome Measures
Time to final dental rehabilitation
Time elapsed until final dental rehabilitation is reached.
Secondary Outcome Measures
Total operating room time
The total time taken in operating room for a procedure
Surgical outcome accuracy (CT imaging)
Accuracy of the proposed surgical outcome assessed via CT scan imaging
Implant survival - Short term
Six month survival rate of the dental implant
Implant survival - Long term
Long term survival rate of the dental implant
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03369366
Brief Title
Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects
Official Title
Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Funding not received.
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillofacial Injuries
Keywords
Maxillofacial Defects, Benign, large tumors requiring surgical resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reconstruction and Dental Rehabilitation
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
NobelActive
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
KLS Martin Mandibular Reconstruction Implant
Intervention Description
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).
Primary Outcome Measure Information:
Title
Time to final dental rehabilitation
Description
Time elapsed until final dental rehabilitation is reached.
Time Frame
6-8 months
Secondary Outcome Measure Information:
Title
Total operating room time
Description
The total time taken in operating room for a procedure
Time Frame
6-8 hours
Title
Surgical outcome accuracy (CT imaging)
Description
Accuracy of the proposed surgical outcome assessed via CT scan imaging
Time Frame
5-10 days post-op
Title
Implant survival - Short term
Description
Six month survival rate of the dental implant
Time Frame
6 months post operatively
Title
Implant survival - Long term
Description
Long term survival rate of the dental implant
Time Frame
one year post operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion and Exclusion Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui P Fernandes, MD, DMD
Organizational Affiliation
Associate Professor; Associate Chair; Chief, Division of Head and Neck Surgery
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be made available to researchers outside of the study.
Learn more about this trial
Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects
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