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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Besancon

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Human Amniotic Membrane
  • Conventional/Standard treatment

Treatment groups

66 Participants
are divided into 2 treatment groups