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Harvesting temporalis myofascial flap for cranio-maxillofacial defects

Improvement of speech and feeding quality in patients with palatal defects by temporalis myofascial flap

Temporalis Myofascial flap

This research is conducted as trial to improve lifestyle of patients with cranio-maxillofacial defects following major insults like trauma or tumor resection in form of speech problems or dysphagia by usage temporalis myofascial flap and assessment of it's effectiveness

Assessment of temporalis myofascial flap effectiveness in reconstruction of cranio-maxillofacial defects

Temporalis Myofascial Flap Effectiveness

The Efficacy of Temporalis Myofascial Flap in Reconstruction of Various Cranio-maxillofacial Defects

Assessment by regular follow up by pin bricks

Assessment will be done in regular follow up visits by video fluoroscopy , trials of swallowing and phonation will be assessed by phoniatricians

Assiut University

Assistant Lecturer of ENT

Nervous System Diseases

Wounds and Injuries

Symptoms and General Pathology

Maxillofacial Injuries

Facies

Facial Injuries

Craniocerebral Trauma

Trauma, Nervous System

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).

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.

NobelActive

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).

KLS Martin Mandibular Reconstruction Implant

Rui P Fernandes, MD, DMD

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:

* 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).

Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects

IPD will not be made available to researchers outside of the study.

Time elapsed until final dental rehabilitation is reached.

The total time taken in operating room for a procedure

Accuracy of the proposed surgical outcome assessed via CT scan imaging

Six month survival rate of the dental implant

Long term survival rate of the dental implant

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Temporalis Myofascial Flap Effectiveness	NCT05298969	Maxillary Sinus...	Temporalis Myof...	-	Assiut University
Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects	NCT03369366	Maxillofacial I...	NobelActive KLS Martin Mand...	16 Years - 60 Years	University of Florida

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