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Human Amniotic Membrane (hAM) for Stage II Maxillomandibular Osteonecrosis Management (amniOST)

Primary Purpose

Osteonecrosis Due to Drugs, Jaw

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Human Amniotic Membrane
Conventional/Standard treatment
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteonecrosis Due to Drugs, Jaw

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de BesanconRecruiting
  • CHU Bordeaux Pellegrin
  • CHU de Dijon
  • CHR Metz Thionville
  • CHU de Reims

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Application of human amniotic membrane (hAM)

Conventional/standard treatment

Arm Description

After conventional/standard treatment, hAM will be applied in a single layer against the bone defect before closure.

Conventional/standard surgery.

Outcomes

Primary Outcome Measures

Number of patients with re-apparition of bone exposure
Number of patients with re-apparition of bone exposure visually observed by the surgeon. Clinical examination: reopening of the scar / reappearance of exposed bone / taking a photograph of the treated area

Secondary Outcome Measures

Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Re-apparition of bone exposure visually observed by the surgeon. Clinical examination: reopening of the scar / reappearance of exposed bone / taking a photograph of the treated area
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Re-apparition of bone exposure visually observed by the surgeon. Clinical examination: reopening of the scar / reappearance of exposed bone / taking a photograph of the treated area
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Re-apparition of bone exposure visually observed by the surgeon. Clinical examination: reopening of the scar / reappearance of exposed bone / taking a photograph of the treated area
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Re-apparition of bone exposure visually observed by the surgeon. Clinical examination: reopening of the scar / reappearance of exposed bone / taking a photograph of the treated area
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Re-apparition of bone exposure visually observed by the surgeon. Clinical examination: reopening of the scar / reappearance of exposed bone / taking a photograph of the treated area
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Re-apparition of bone exposure visually observed by the surgeon. Clinical examination: reopening of the scar / reappearance of exposed bone / taking a photograph of the treated area
To assess pain with Visual Analogue Scale
Pain assessed by a Visual Analogue Scale (VAS). This EVA scale will be supplemented by a collection of information on the use of analgesics if necessary. Also patients who would have to take analgesics will fill out a "logbook" which will specify the class of the drug and the dosage.
To assess pain with Visual Analogue Scale
Pain assessed by a Visual Analogue Scale (VAS). This EVA scale will be supplemented by a collection of information on the use of analgesics if necessary. Also patients who would have to take analgesics will fill out a "logbook" which will specify the class of the drug and the dosage.
To assess pain with Visual Analogue Scale
Pain assessed by a Visual Analogue Scale (VAS). This EVA scale will be supplemented by a collection of information on the use of analgesics if necessary. Also patients who would have to take analgesics will fill out a "logbook" which will specify the class of the drug and the dosage.
To assess pain with Visual Analogue Scale
Pain assessed by a Visual Analogue Scale (VAS). This EVA scale will be supplemented by a collection of information on the use of analgesics if necessary. Also patients who would have to take analgesics will fill out a "logbook" which will specify the class of the drug and the dosage.
To assess pain with Visual Analogue Scale
Pain assessed by a Visual Analogue Scale (VAS). This EVA scale will be supplemented by a collection of information on the use of analgesics if necessary. Also patients who would have to take analgesics will fill out a "logbook" which will specify the class of the drug and the dosage.
To assess pain with Visual Analogue Scale
Pain assessed by a Visual Analogue Scale (VAS). This EVA scale will be supplemented by a collection of information on the use of analgesics if necessary. Also patients who would have to take analgesics will fill out a "logbook" which will specify the class of the drug and the dosage.
To assess pain with Visual Analogue Scale
Pain assessed by a Visual Analogue Scale (VAS). This EVA scale will be supplemented by a collection of information on the use of analgesics if necessary. Also patients who would have to take analgesics will fill out a "logbook" which will specify the class of the drug and the dosage.
Proportion of subjects with a complication at the site of mucosal healing
On examination of the area of interest, during each visit, search for the presence of: Minor complications: pain and/or erythema and/or abscess and/or purulent discharge, Major complications: diffuse soft tissue infection (cellulitis), orostoma, suborbital abscess, mandibular fracture.
Proportion of subjects with a complication at the site of mucosal healing
On examination of the area of interest, during each visit, search for the presence of: Minor complications: pain and/or erythema and/or abscess and/or purulent discharge, Major complications: diffuse soft tissue infection (cellulitis), orostoma, suborbital abscess, mandibular fracture.
Proportion of subjects with a complication at the site of mucosal healing
On examination of the area of interest, during each visit, search for the presence of: Minor complications: pain and/or erythema and/or abscess and/or purulent discharge, Major complications: diffuse soft tissue infection (cellulitis), orostoma, suborbital abscess, mandibular fracture.
Proportion of subjects with a complication at the site of mucosal healing
On examination of the area of interest, during each visit, search for the presence of: Minor complications: pain and/or erythema and/or abscess and/or purulent discharge, Major complications: diffuse soft tissue infection (cellulitis), orostoma, suborbital abscess, mandibular fracture.
Proportion of subjects with a complication at the site of mucosal healing
On examination of the area of interest, during each visit, search for the presence of: Minor complications: pain and/or erythema and/or abscess and/or purulent discharge, Major complications: diffuse soft tissue infection (cellulitis), orostoma, suborbital abscess, mandibular fracture.
Proportion of subjects with a complication at the site of mucosal healing
On examination of the area of interest, during each visit, search for the presence of: Minor complications: pain and/or erythema and/or abscess and/or purulent discharge, Major complications: diffuse soft tissue infection (cellulitis), orostoma, suborbital abscess, mandibular fracture.
Proportion of subjects with a complication at the site of mucosal healing
On examination of the area of interest, during each visit, search for the presence of: Minor complications: pain and/or erythema and/or abscess and/or purulent discharge, Major complications: diffuse soft tissue infection (cellulitis), orostoma, suborbital abscess, mandibular fracture.
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
Proportion of subjects with new bone formation
Presence of newly formed bone assessed by cone-beam imaging
Proportion of subjects with new bone formation
Presence of newly formed bone assessed by cone-beam imaging

Full Information

First Posted
October 24, 2022
Last Updated
October 11, 2023
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT05664815
Brief Title
Human Amniotic Membrane (hAM) for Stage II Maxillomandibular Osteonecrosis Management
Acronym
amniOST
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Medication-Related Osteonecrosis of the Jaw (MRONJ) is a complication of taking anti-tumor (anti-angiogenic) and bone anti-resorptive treatments (biphosphonates, Denosumab) which impact bone healing and renewal capacities, which can lead to bone necrosis. It affects 1 to 10% of patients and is classified into 4 stages. There is no reference document for their management, which requires antibiotics, local antiseptics and tissue debridement sometimes associated with sequestrectomy. The objective of treatment is very often to obtain healing of the oral mucosa to cover the exposed bone. Without treatment, stage II MRONJ can progress to stage III, with orostoma, pathological fractures and extra-fistula. The human amniotic membrane (hAM) has poor (even no) immunogenicity and exerts an anti-inflammatory, anti-fibrotic, antimicrobial, antiviral and analgesic effect. It is a source of multipotent stem cells and growth factors that promote tissue regeneration. A pioneering, non-comparative study reports the use of hAM in MRONJ with very encouraging results in terms of re-epithelialization, absence of pain and infection (Ragazzo 2018). Recently, the same team published a retrospective study where 49 patients (stage 1 to 3) were included, including 27 treated with hAM (Ragazzo 2021). They report a significant improvement in quality of life and pain in the treated group. hAM would provide a new approach in the treatment of stage II MRONJ by acting on: the quality and speed of mucosal healing, pain, even infection and regeneration of the underlying bone. 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 three months after the operation. In second objectives will be evaluated: pain, complications at the site of healing of the mucosa (erythema, abscess, purulent discharge, diffuse infection of soft tissues (cellulitis), orostoma, suborbital abscess, mandibular fracture), oral health -dental/quality of life and new bone formation at subsequent visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteonecrosis Due to Drugs, Jaw

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomization 3:1
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Application of human amniotic membrane (hAM)
Arm Type
Experimental
Arm Description
After conventional/standard treatment, hAM will be applied in a single layer against the bone defect before closure.
Arm Title
Conventional/standard treatment
Arm Type
Active Comparator
Arm Description
Conventional/standard surgery.
Intervention Type
Biological
Intervention Name(s)
Human Amniotic Membrane
Other Intervention Name(s)
hAM, amnion
Intervention Description
After conventional/standard treatment, hAM will be applied in a single layer against the bone defect with, if possible, a burial of a few millimeters under the mucous edges. With the idea of apprehending a possible dose effect, the hAM will be adapted to the size of the bone/mucous defect, mesenchymal side against the bone. For closure after hAM grafting : 2 options are possible: Edge-to-edge closure if sufficient mucosal laxity, Edge rapprochement by cross points. If necessary: possible incision of the periosteum to give laxity to the mucosa.
Intervention Type
Other
Intervention Name(s)
Conventional/Standard treatment
Intervention Description
Surgical procedure: Endo-oral approach: Trimming of the mucous edges if they are necrotic or inflamed (granulation tissue) For the bone: either simple sequestrectomy (the mobile sequestered bone is grabbed using forceps); either reaming until bleeding is obtained; either resection with the rongeur; either monobloc resection of the entire necrotic fragment with a saw or with a piezzotome (ultrasound); or a combination of different techniques. Rq: the resection of the necrotic bone (according to the practices of the center) will operate until the appearance of an "apparently healthy" bone (bone bleeding, clean appearance of the bone site) Closure of the mucosa with possible incision of the periosteum to provide laxity: Suture points by points separated in one plane with non-absorbable braided thread of the 3.0 "silk thread" type and round needle.
Primary Outcome Measure Information:
Title
Number of patients with re-apparition of bone exposure
Description
Number of patients with re-apparition of bone exposure visually observed by the surgeon. Clinical examination: reopening of the scar / reappearance of exposed bone / taking a photograph of the treated area
Time Frame
Between Day 1 post-surgery and Month 3 post-surgery
Secondary Outcome Measure Information:
Title
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Description
Re-apparition of bone exposure visually observed by the surgeon. Clinical examination: reopening of the scar / reappearance of exposed bone / taking a photograph of the treated area
Time Frame
Day 0 (the day of the surgery) or Day 1 post-surgery
Title
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Description
Re-apparition of bone exposure visually observed by the surgeon. Clinical examination: reopening of the scar / reappearance of exposed bone / taking a photograph of the treated area
Time Frame
Visit 1 (7 to 10 days post-surgery)
Title
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Description
Re-apparition of bone exposure visually observed by the surgeon. Clinical examination: reopening of the scar / reappearance of exposed bone / taking a photograph of the treated area
Time Frame
Visit 2 (14 to 15 days post-surgery)
Title
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Description
Re-apparition of bone exposure visually observed by the surgeon. Clinical examination: reopening of the scar / reappearance of exposed bone / taking a photograph of the treated area
Time Frame
Visit 3 (One month post-surgery),
Title
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Description
Re-apparition of bone exposure visually observed by the surgeon. Clinical examination: reopening of the scar / reappearance of exposed bone / taking a photograph of the treated area
Time Frame
Visit 5 (6 months post-surgery)
Title
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Description
Re-apparition of bone exposure visually observed by the surgeon. Clinical examination: reopening of the scar / reappearance of exposed bone / taking a photograph of the treated area
Time Frame
Visit 6 (12 months post-surgery)
Title
To assess pain with Visual Analogue Scale
Description
Pain assessed by a Visual Analogue Scale (VAS). This EVA scale will be supplemented by a collection of information on the use of analgesics if necessary. Also patients who would have to take analgesics will fill out a "logbook" which will specify the class of the drug and the dosage.
Time Frame
Day 0 or Day 1 (if hospitalized patient)
Title
To assess pain with Visual Analogue Scale
Description
Pain assessed by a Visual Analogue Scale (VAS). This EVA scale will be supplemented by a collection of information on the use of analgesics if necessary. Also patients who would have to take analgesics will fill out a "logbook" which will specify the class of the drug and the dosage.
Time Frame
Visit 1 (7 to 10 days post-surgery)
Title
To assess pain with Visual Analogue Scale
Description
Pain assessed by a Visual Analogue Scale (VAS). This EVA scale will be supplemented by a collection of information on the use of analgesics if necessary. Also patients who would have to take analgesics will fill out a "logbook" which will specify the class of the drug and the dosage.
Time Frame
Visit 2 (14 to 15 days post-surgery)
Title
To assess pain with Visual Analogue Scale
Description
Pain assessed by a Visual Analogue Scale (VAS). This EVA scale will be supplemented by a collection of information on the use of analgesics if necessary. Also patients who would have to take analgesics will fill out a "logbook" which will specify the class of the drug and the dosage.
Time Frame
Visit 3 ( 1 Month post-surgery)
Title
To assess pain with Visual Analogue Scale
Description
Pain assessed by a Visual Analogue Scale (VAS). This EVA scale will be supplemented by a collection of information on the use of analgesics if necessary. Also patients who would have to take analgesics will fill out a "logbook" which will specify the class of the drug and the dosage.
Time Frame
Visit 4 (3 Month post-surgery),
Title
To assess pain with Visual Analogue Scale
Description
Pain assessed by a Visual Analogue Scale (VAS). This EVA scale will be supplemented by a collection of information on the use of analgesics if necessary. Also patients who would have to take analgesics will fill out a "logbook" which will specify the class of the drug and the dosage.
Time Frame
Visit 5 (6 Month post-surgery)
Title
To assess pain with Visual Analogue Scale
Description
Pain assessed by a Visual Analogue Scale (VAS). This EVA scale will be supplemented by a collection of information on the use of analgesics if necessary. Also patients who would have to take analgesics will fill out a "logbook" which will specify the class of the drug and the dosage.
Time Frame
Visit 6 ( 12 Month post-surgery)
Title
Proportion of subjects with a complication at the site of mucosal healing
Description
On examination of the area of interest, during each visit, search for the presence of: Minor complications: pain and/or erythema and/or abscess and/or purulent discharge, Major complications: diffuse soft tissue infection (cellulitis), orostoma, suborbital abscess, mandibular fracture.
Time Frame
Day 0 or Day 1 post-surgery (if hospitalized patient)
Title
Proportion of subjects with a complication at the site of mucosal healing
Description
On examination of the area of interest, during each visit, search for the presence of: Minor complications: pain and/or erythema and/or abscess and/or purulent discharge, Major complications: diffuse soft tissue infection (cellulitis), orostoma, suborbital abscess, mandibular fracture.
Time Frame
visit 1 (7 to 10 days post-surgery)
Title
Proportion of subjects with a complication at the site of mucosal healing
Description
On examination of the area of interest, during each visit, search for the presence of: Minor complications: pain and/or erythema and/or abscess and/or purulent discharge, Major complications: diffuse soft tissue infection (cellulitis), orostoma, suborbital abscess, mandibular fracture.
Time Frame
Visit 2 (14 to 15 days post-surgery)
Title
Proportion of subjects with a complication at the site of mucosal healing
Description
On examination of the area of interest, during each visit, search for the presence of: Minor complications: pain and/or erythema and/or abscess and/or purulent discharge, Major complications: diffuse soft tissue infection (cellulitis), orostoma, suborbital abscess, mandibular fracture.
Time Frame
Visit 3 (Month1 post-surgery)
Title
Proportion of subjects with a complication at the site of mucosal healing
Description
On examination of the area of interest, during each visit, search for the presence of: Minor complications: pain and/or erythema and/or abscess and/or purulent discharge, Major complications: diffuse soft tissue infection (cellulitis), orostoma, suborbital abscess, mandibular fracture.
Time Frame
Visit 4 ( 3 Month post-surgery)
Title
Proportion of subjects with a complication at the site of mucosal healing
Description
On examination of the area of interest, during each visit, search for the presence of: Minor complications: pain and/or erythema and/or abscess and/or purulent discharge, Major complications: diffuse soft tissue infection (cellulitis), orostoma, suborbital abscess, mandibular fracture.
Time Frame
Visit 5 (6 Month post-surgery)
Title
Proportion of subjects with a complication at the site of mucosal healing
Description
On examination of the area of interest, during each visit, search for the presence of: Minor complications: pain and/or erythema and/or abscess and/or purulent discharge, Major complications: diffuse soft tissue infection (cellulitis), orostoma, suborbital abscess, mandibular fracture.
Time Frame
Visit 6 (Month 12 post-surgery)
Title
quality of life related to oral health
Description
Oral health impact profile OHIP 14 quality of life score
Time Frame
Day 0 or Day +1 post-surgery (if hospitalized patient)
Title
quality of life related to oral health
Description
Oral health impact profile OHIP 14 quality of life score
Time Frame
Visit1 (7 to10 days post-surgery)
Title
quality of life related to oral health
Description
Oral health impact profile OHIP 14 quality of life score
Time Frame
Visit 2 (14 to 15 days post-surgery)
Title
quality of life related to oral health
Description
Oral health impact profile OHIP 14 quality of life score
Time Frame
V3 (Month 1 post-surgery),
Title
quality of life related to oral health
Description
Oral health impact profile OHIP 14 quality of life score
Time Frame
Visit 4 ( Month 3 post-surgery)
Title
quality of life related to oral health
Description
Oral health impact profile OHIP 14 quality of life score
Time Frame
Visit 5 (Month 6 post-surgery)
Title
quality of life related to oral health
Description
Oral health impact profile OHIP 14 quality of life score
Time Frame
Visit 6 (Month 12 post-surgery)
Title
Proportion of subjects with new bone formation
Description
Presence of newly formed bone assessed by cone-beam imaging
Time Frame
Visit 4 (Month 3)
Title
Proportion of subjects with new bone formation
Description
Presence of newly formed bone assessed by cone-beam imaging
Time Frame
Visit 5 (Month 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florelle GINDRAUX, PhD
Phone
033381218998
Email
fgindraux@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélien LOUVRIER, MD, PhD
Organizational Affiliation
CHU de Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besancon
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Astrid POZET
Phone
+33381218988
Email
apozet@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Aurélien LOUVRIER, MD-PhD
Facility Name
CHU Bordeaux Pellegrin
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathilde FENELON, MD
Email
mathilde.fenelon@chu-bordeaux.fr
Facility Name
CHU de Dijon
City
Dijon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Narcisse ZWETYENGA, MD
Email
narcisse.zwetyenga@chu-dijon.fr
Facility Name
CHR Metz Thionville
City
Metz
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Remi CURIEN, MD
Email
r.curien@chr-metz-thionville.fr
Facility Name
CHU de Reims
City
Reims
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien LAURENCE, MD
Email
slaurence@chu-reims.fr

12. IPD Sharing Statement

Learn more about this trial

Human Amniotic Membrane (hAM) for Stage II Maxillomandibular Osteonecrosis Management

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