An interventional study of NobelActive and KLS Martin Mandibular Reconstruction Implant in Maxillofacial Injuries, sponsored by University of Florida. Withdrawn. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-07-17.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
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:
Surgical treatment protocol involves:
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).
Inclusion and Exclusion Criteria
Inclusion Criteria:
Exclusion Criteria:
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 · Device: KLS Martin Mandibular Reconstruction Implant
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.
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).
Time to final dental rehabilitation
Time elapsed until final dental rehabilitation is reached.
Time frame: 6-8 months
Total operating room time
The total time taken in operating room for a procedure
Time frame: 6-8 hours
Surgical outcome accuracy (CT imaging)
Accuracy of the proposed surgical outcome assessed via CT scan imaging
Time frame: 5-10 days post-op
Implant survival - Short term
Six month survival rate of the dental implant
Time frame: 6 months post operatively
Implant survival - Long term
Long term survival rate of the dental implant
Time frame: one year post operatively
No study locations are listed for this record.
Plan to share: No — IPD will not be made available to researchers outside of the study.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Maxillofacial Injuries
University of Florida