NANOTEX BONE Graft along with Fibula Flap in the Reconstruction of Segmental Mandibular Defect: Protocol for Pilot Clinical Trial.

Abstract

Introduction and objectives: Mandible reconstruction with vascularized fibula flap is the standard treatment for segmental mandibulectomy in patients with tumor or trauma. But the height of the fibula graft is insufficient for dental implant placement and prosthetic rehabilitation to replace the missing teeth, which in turn will compromise the functional efficiency and aesthetics of the patient. Although the bone height can be augmented through onlay grafting with iliac crest, it is associated with limitations like donor site morbidity and fast resorbability. This suggests the need for a synthetic biomaterial for vertical bone augmentation in implant dentistry.We have developed a biomimetic, porous, mechanically stable, and biodegradable nanocomposite named "NANOTEX BONE Graft" and its bone regeneration potential was evaluated in pre-clinical animal models. In this clinical trial, the safety as well as the efficacy of NANOTEX to augment new bone over fibula and further its ability to integrate with dental implants will be studied. The study has received the approval of the Ethics Committee of Amrita Institute of Medical Sciences and Central Drugs Standard Control Organization (CDSCO), India.

Methods: We have designed a prospective, single-center, non-randomized pilot clinical study. Patients with benign tumor or trauma indicated for mandibular reconstruction followed by implant rehabilitation will be included in the study. Eligible patients will be enrolled after obtaining informed consent. The study will be initiated and followed up as per defined timelines.

Highlights: Resection of benign mandibular tumours necessitates surgical removal of jaw bone and adjacent affected areas.The segmental mandibulectomy leaves the patient with functional impairments and aesthetic defects which in turn affect the quality of life.The standard treatment of reconstruction with vascularized fibula flap has challenge in achieving sufficient vertical bone height for implant placement and prosthetic rehabilitation.Alternate surgical techniques cause donor site morbidity and surgical complications.There is need for a synthetic biomaterial to be grafted over fibula for vertical bone augmentation.NANOTEX BONE Graft, a nanofibrous composite scaffold that mimics native bone, promote cell infiltration, neo-angiogenesis and new bone formation.Preclinical studies of NANOTEX in animal models showed bone tissue regeneration, better biodegradation in critical sized defects and efficient integration with dental implants.This clinical study propose to evaluate the safety and efficacy of NANOTEX bone graft augmented over fibula in bone regeneration and Titanium dental implant integration.