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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Withdrawn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
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

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

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 6, 2017
    Last Updated
    July 16, 2019
    Sponsor
    University of Florida
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    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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