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Active Not Recruiting
NCT05664815
Human Amniotic Membrane (hAM) for Stage II Maxillomandibular Osteonecrosis Management
Conditions: Osteonecrosis Due to Drugs, Jaw
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 66
Sponsor: Centre Hospitalier Universitaire de Besancon
Location: France
Summary
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
INCLUSION CRITERIAMen and women over the age of 18Patient 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 historyMRONJ 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 IIPatients with stage II MRONJ of childbearing age with current contraception or patients already postmenopausalSignature 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 studyAffiliation to a French social security scheme or beneficiary of such a schemeNON-INCLUSION CRITERIALife expectancy of less than 6 months assessed by oncologistsExistence of an evolving cervico-facial neoplasia or an evolving oral neoplastic process informed by oncologistsHistory of oral and/or cervico-facial radiotherapyAllergy to one of these two antibiotics: amoxicillin-clavulanic acid or clindamycin-metronidazole combinationPatient contraindicated for surgery due to his state of health, with general anesthesia or local anesthesia.MRONJ stage I and stage IIIStage II MRONJ in patients with only osteoporosisPatients receiving treatments that may affect bone and/or mucous tissue as well as their metabolism: Patients on long-term corticosteroid therapy or immunosuppressantsPatients 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 contraceptionLegal incapacity or limited legal capacitySubject unlikely to cooperate in the study and/or low cooperation anticipated by the investigatorSubject not affiliated to a social security schemePatient under guardianship, curatorship or imprisonmentPatient who notified his refusal to participate in the researchPatient who participates in another clinical researchEXCLUSION CRITERIADuring 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.
Source: ClinicalTrials.gov (NCT05664815). StuddyBuddy aggregates publicly available trial information.