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New treatment option for Osteonecrosis Due to Drugs, Jaw
Official title Human Amniotic Membrane (hAM) for Stage II Maxillomandibular Osteonecrosis Management
ClinicalTrials.gov ID: NCT05664815
What this study is testing
What is Human Amniotic Membrane?
Human Amniotic Membrane is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for osteonecrosis due to drugs, jaw.
Also referred to as hAM, amnion.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- MRONJ stage II certified clinically and radiologically. Also in the maxilla, stage II MRONJ without bucco-sinus communication after excision of the...
- 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...
You likely can't join 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...
- 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.
See the full eligibility 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...
- 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...
- 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...
- Affiliation to a French social security scheme or beneficiary of such a scheme NON- 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Besançon, France
- Bordeaux, France
- Dijon, France
- Metz, France
- Reims, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Besançon, France; Bordeaux, France; Dijon, France; Metz, France; Reims, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.