Human Amniotic Membrane (hAM) for Stage II Maxillomandibular Osteonecrosis Management (NCT05664815) | Clinical Trial Compass
RecruitingPhase 2
Human Amniotic Membrane (hAM) for Stage II Maxillomandibular Osteonecrosis Management
France66 participantsStarted 2023-09-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA
* 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 …
What they're measuring
1
Number of patients with re-apparition of bone exposure
Timeframe: Between Day 1 post-surgery and Month 3 post-surgery
Trial details
NCT IDNCT05664815
SponsorCentre Hospitalier Universitaire de Besancon