Clinical trial NCT03369366: Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects
Official title: Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Maxillofacial Injuries
Keywords: Maxillofacial Defects
Benign, large tumors requiring surgical resection
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Time to final dental rehabilitation
timeFrame: 6-8 months
Secondary outcomes:
measure: Total operating room time
timeFrame: 6-8 hours
measure: Surgical outcome accuracy (CT imaging)
timeFrame: 5-10 days post-op
measure: Implant survival - Short term
timeFrame: 6 months post operatively
measure: Implant survival - Long term
timeFrame: one year post operatively
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor; Associate Chair; Chief, Division of Head and Neck Surgery
name: Rui P Fernandes, MD, DMD
role: PRINCIPAL_INVESTIGATOR
References: