Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects

Not Applicable

Withdrawn

• Conditions: Maxillofacial Injuries
• Interventions: Device: NobelActive; Device: KLS Martin Mandibular Reconstruction Implant

• Registration Number: NCT03369366
• Lead Sponsor: 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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-12
• Status Verified: 2019-07
• Study Start: 2019-07
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-17
• Primary Completion: 2021-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reconstruction and Dental Rehabilitation	NobelActive	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).
Reconstruction and Dental Rehabilitation	KLS Martin Mandibular Reconstruction Implant	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).

Primary Outcome Measures

Name	Time	Method
Time to final dental rehabilitation	6-8 months	Time elapsed until final dental rehabilitation is reached.

Secondary Outcome Measures

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