Human Amniotic Membrane (hAM) for Stage II Maxillomandibular Osteonecrosis Management

Medication‐Related Osteonecrosis of the Jaw (MRONJ) is a complication of takinganti‐tumor (anti‐angiogenic) and bone anti‐resorptive treatments (biphosphonates,Denosumab) which impact bone healing and renewal capacities, which can lead to bonenecrosis. It affects 1 to 10% of patients and is classified into 4 stages.There is no reference document for their management, which requires antibiotics, localantiseptics and tissue debridement sometimes associated with sequestrectomy. Theobjective of treatment is very often to obtain healing of the oral mucosa to cover theexposed bone. Without treatment, stage II MRONJ can progress to stage III, with orostoma,pathological fractures and extra‐fistula.The human amniotic membrane (hAM) has poor (even no) immunogenicity and exerts ananti‐inflammatory, anti‐fibrotic, antimicrobial, antiviral and analgesic effect. It is asource of multipotent stem cells and growth factors that promote tissue regeneration.A pioneering, non‐comparative study reports the use of hAM in MRONJ with very encouragingresults in terms of re‐epithelialization, absence of pain and infection (Ragazzo 2018).Recently, the same team published a retrospective study where 49 patients (stage 1 to 3)were included, including 27 treated with hAM (Ragazzo 2021). They report a significantimprovement in quality of life and pain in the treated group.hAM would provide a new approach in the treatment of stage II MRONJ by acting on: thequality and speed of mucosal healing, pain, even infection and regeneration of theunderlying bone.This study aims to demonstrate, during the first standard surgical management of patientswith stage II MRONJ, the effect of the implantation of a cryopreserved hAM on themaxillomandibular bone, on the healing of the oral mucosa three months after theoperation.In second objectives will be evaluated: pain, complications at the site of healing of themucosa (erythema, abscess, purulent discharge, diffuse infection of soft tissues(cellulitis), orostoma, suborbital abscess, mandibular fracture), oral health‐dental/quality of life and new bone formation at subsequent visits.