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

Recruiting now · Phase 2

Conditions studied: Osteonecrosis Due to Drugs, Jaw

In brief

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.

Key facts

Study ID

NCT05664815

Run by

Centre Hospitalier Universitaire de Besancon

People needed

66

Starts

2023-09-22

Expected to finish

2026-03-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• NON-INCLUSION CRITERIA
• Life expectancy of less than 6 months assessed by oncologists
• Existence of an evolving cervico-facial neoplasia or an evolving oral neoplastic process informed by oncologists
• History of oral and/or cervico-facial radiotherapy
• Allergy to one of these two antibiotics: amoxicillin-clavulanic acid or clindamycin-metronidazole combination
• Patient contraindicated for surgery due to his state of health, with general anesthesia or local anesthesia.
• MRONJ stage I and stage III
• Stage II MRONJ in patients with only osteoporosis
• Patients receiving treatments that may affect bone and/or mucous tissue as well as their metabolism: Patients on long-term corticosteroid therapy or immunosuppressants
• Patients with other diseases that may affect bone and/or mucous tissue as well as their metabolism: Bone diseases (such as brittle bone disease or Osteogenesis imperfecta, primary bone tumors in the maxilla or mandible (osteosarcoma, sarcoma, rhabdomyosarcoma ,…), any other malignant bone tumour; metabolic diseases with bone repercussions (Paget's disease, osteomalacia,…)
• Patients of childbearing age without contraception
• Legal incapacity or limited legal capacity
• Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
• Subject not affiliated to a social security scheme
• Patient under guardianship, curatorship or imprisonment
• Patient who notified his refusal to participate in the research
• Patient who participates in another clinical research

You may not qualify if…

• During surgery: Discovery of an interrupting MRONJ with damage to the basilar edge (which corresponds to stage III).
• During surgery: Following a sequestrectomy discovery of spontaneous or ongoing healing.
• During the inclusion period: Patient to benefit from invasive "dental" surgeries directly related to bone exposure and in conjunction with taking risky molecules (factors favoring the occurrence of MRONJ): dental avulsions, curettage apical granulomas or cysts, endodontic treatments, or alveolar bone procedure (regularization of ridges).
• During the inclusion period: Patient with metastases all over the mandible.
• During the inclusion period: State of health of the patient which deteriorates due to his cancer during the inclusion period.

Where it is running

• CHU de Besancon — Besançon, France (enrolling)
• CHU Bordeaux Pellegrin — Bordeaux, France
• CHU de Dijon — Dijon, France
• CHR Metz Thionville — Metz, France
• CHU de Reims — Reims, France

Full record on ClinicalTrials.gov

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