Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects

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.

Study Overview

• Status: Withdrawn
• Conditions: Maxillofacial Injuries
• Intervention / Treatment: Device: NobelActive; Device: KLS Martin Mandibular Reconstruction Implant

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
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to final dental rehabilitation	Time elapsed until final dental rehabilitation is reached.	6-8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total operating room time	The total time taken in operating room for a procedure	6-8 hours
Surgical outcome accuracy (CT imaging)	Accuracy of the proposed surgical outcome assessed via CT scan imaging	5-10 days post-op
Implant survival - Short term	Six month survival rate of the dental implant	6 months post operatively
Implant survival - Long term	Long term survival rate of the dental implant	one year post operatively

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Rui P Fernandes, MD, DMD, Associate Professor; Associate Chair; Chief, Division of Head and Neck Surgery

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Maxillofacial Defects; Benign, large tumors requiring surgical resection
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Maxillofacial Injuries
• Other Study ID Numbers: IRB201702812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will not be made available to researchers outside of the study.

Drug and device information, study documents

• 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