Benefit of Cryopreserved Human Amniotic Membrane (hAM) on Oral Mucosal Healing Among Patients With Stage II Maxillomandibular Osteonecrosis Induced by Antiresorptive and/or Anti-angiogenic Therapies: a Phase II Randomized Trial
This study aims to demonstrate, during the first standard surgical management of patients with stage II MRONJ, the effect of the implantation of a cryopreserved hAM on the maxillomandibular bone, on the healing of the oral mucosa.
• Men and women over the age of 18
• Patient treated in the context of a tumor pathology during which he received treatment with bisphosphonates, Denosumab or anti-angiogenics, and/or, very often, switch of treatment or combination. Current treatment or mention of treatment in patient history
• MRONJ stage II certified clinically and radiologically. Also in the maxilla, stage II MRONJ without bucco-sinus communication after excision of the necrotic bone. Similarly, if a tooth with antral roots must be extracted and creates a bucco-sinus communication, if a MRONJ results, it will be stage II
• Patients with stage II MRONJ of childbearing age with current contraception or patients already postmenopausal
• Signature of the informed consent to participate indicating that the subject has understood the purpose and the procedures required by the study, that he agrees to participate in the study as well as to comply with the requirements and restrictions inherent in this study
• Affiliation to a French social security scheme or beneficiary of such a scheme