Actively Recruiting
Human Amniotic Membrane (hAM) for Stage II Maxillomandibular Osteonecrosis Management
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2024-09-19
66
Participants Needed
5
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Human Amniotic Membrane (hAM) for Stage II Maxillomandibular Osteonecrosis Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women over the age of 18
- Treated for cancer with bisphosphonates, Denosumab, or anti-angiogenic therapies, including past or current treatment
- Clinically and radiologically confirmed stage II MRONJ, including maxilla cases without bucco-sinus communication after necrotic bone removal
- Patients of childbearing age using contraception or postmenopausal
- Signed informed consent to participate and comply with study requirements
- Affiliated with a French social security scheme or beneficiary of such a scheme
You will not qualify if you...
- Life expectancy under 6 months as assessed by oncologists
- Presence of ongoing cervico-facial or oral cancer
- History of oral or cervico-facial radiotherapy
- Allergy to amoxicillin-clavulanic acid or clindamycin-metronidazole combination
- Contraindication to surgery under general or local anesthesia
- MRONJ stage I or stage III
- Stage II MRONJ patients with osteoporosis only
- Use of long-term corticosteroids or immunosuppressants
- Presence of bone diseases like brittle bone disease, primary bone tumors, or metabolic bone disorders
- Childbearing age patients without contraception
- Legal incapacity or limited legal capacity
- Expected lack of cooperation in the study
- Not affiliated with a social security scheme
- Under guardianship, curatorship, or imprisonment
- Refusal to participate in the research
- Participation in another clinical research study
- Discovery during surgery of stage III MRONJ or spontaneous healing after sequestrectomy
- Need for invasive dental surgeries related to bone exposure during inclusion
- Mandibular metastases during inclusion
- Deterioration of health due to cancer during inclusion
AI-Screening
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Trial Site Locations
Total: 5 locations
1
CHU de Besancon
Besançon, France, 25030
Actively Recruiting
2
CHU Bordeaux Pellegrin
Bordeaux, France
Not Yet Recruiting
3
CHU de Dijon
Dijon, France
Not Yet Recruiting
4
CHR Metz Thionville
Metz, France
Not Yet Recruiting
5
CHU de Reims
Reims, France
Not Yet Recruiting
Research Team
F
Florelle GINDRAUX, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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