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Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects

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ClinicalTrials.gov Identifier: NCT03369366
Recruitment Status : Withdrawn (Funding not received.)
First Posted : December 12, 2017
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
Osteo Science Foundation
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Maxillofacial Injuries Device: NobelActive Device: KLS Martin Mandibular Reconstruction Implant Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects
Estimated Study Start Date : August 15, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Reconstruction and Dental Rehabilitation
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).
Device: NobelActive
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.

Device: KLS Martin Mandibular Reconstruction Implant
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 Measures :
  1. Time to final dental rehabilitation [ Time Frame: 6-8 months ]
    Time elapsed until final dental rehabilitation is reached.


Secondary Outcome Measures :
  1. Total operating room time [ Time Frame: 6-8 hours ]
    The total time taken in operating room for a procedure

  2. Surgical outcome accuracy (CT imaging) [ Time Frame: 5-10 days post-op ]
    Accuracy of the proposed surgical outcome assessed via CT scan imaging

  3. Implant survival - Short term [ Time Frame: 6 months post operatively ]
    Six month survival rate of the dental implant

  4. Implant survival - Long term [ Time Frame: one year post operatively ]
    Long term survival rate of the dental implant



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369366


Sponsors and Collaborators
University of Florida
Osteo Science Foundation
Investigators
Principal Investigator: Rui P Fernandes, MD, DMD Associate Professor; Associate Chair; Chief, Division of Head and Neck Surgery

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03369366     History of Changes
Other Study ID Numbers: IRB201702812
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be made available to researchers outside of the study.

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

Keywords provided by University of Florida:
Maxillofacial Defects
Benign, large tumors requiring surgical resection

Additional relevant MeSH terms:
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries