Using human amniotic membrane to treat stage II jaw osteonecrosis

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 is testing whether using human amniotic membrane during surgery can help people with stage II jaw osteonecrosis heal better and feel less pain.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Besancon (other)
• Drugs / interventions: Denosumab
• Locations: 5 sites (Besançon and 4 other locations)
• Trial ID: NCT05664815 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of cryopreserved human amniotic membrane (hAM) implantation during the surgical management of patients with stage II Medication-Related Osteonecrosis of the Jaw (MRONJ). The aim is to enhance healing of the oral mucosa and improve bone regeneration in patients who have experienced osteonecrosis due to anti-tumor and bone anti-resorptive treatments. The study will assess the safety and efficacy of hAM in promoting tissue regeneration and alleviating symptoms associated with MRONJ. Participants will receive standard treatment alongside hAM to evaluate its potential benefits.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 who have been treated with bisphosphonates, Denosumab, or anti-angiogenics and have clinically and radiologically confirmed stage II MRONJ.

Not a fit: Patients with stage III MRONJ or those not receiving the specified anti-tumor treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve healing outcomes and quality of life for patients suffering from stage II MRONJ.

How similar studies have performed: Previous studies have shown promising results using hAM in MRONJ treatment, indicating potential for success in this approach.

Eligibility criteria

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 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

EXCLUSION CRITERIA

* 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 this trial is running

Besançon and 4 other locations

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

Study contacts

• Principal investigator: Aurélien LOUVRIER, MD, PhD — CHU de Besançon
• Study coordinator: Florelle GINDRAUX, PhD

Conditions: Osteonecrosis Due to Drugs, Jaw