Osteonecrosis Due to Drugs, JawPhase 2amniOSTNCT05664815
Human Amniotic Membrane (hAM) for Stage II Maxillomandibular Osteonecrosis Management
A Phase 2 study testing Human Amniotic Membrane and Conventional/Standard treatment in people with Osteonecrosis Due to Drugs, Jaw, run by Centre Hospitalier Universitaire de Besancon at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteonecrosis Due to Drugs, Jaw
- What is being tested?
- Human Amniotic Membrane and Conventional/Standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 5 sitesFrance
- Study dates
- 22 Sep 2023to Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 23Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU de Besancon
Besançon, 25030
Astrid POZET, +33381218988, apozet@chu-besancon.fr
Aurélien LOUVRIER, MD-PhD
- Not yet recruiting
CHU Bordeaux Pellegrin
Bordeaux
Mathilde FENELON, MD, mathilde.fenelon@chu-bordeaux.fr
- Not yet recruiting
CHU de Dijon
Dijon
Narcisse ZWETYENGA, MD, narcisse.zwetyenga@chu-dijon.fr
- Not yet recruiting
CHR Metz Thionville
Metz
Remi CURIEN, MD, r.curien@chr-metz-thionville.fr
- Not yet recruiting
CHU de Reims
Reims
Sébastien LAURENCE, MD, slaurence@chu-reims.fr
About this study
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
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.
Read the 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.
- Conditions
- Osteonecrosis Due to Drugs, Jaw
- Being tested
- Human Amniotic Membrane, Conventional/Standard treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Amniotic MembraneBiological
Also called hAM, amnion
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.
Conventional/Standard treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Application of human amniotic membrane (hAM) | Experimental | After conventional/standard treatment, hAM will be applied in a single layer against the bone defect before closure. Receives: Biological: Human Amniotic Membrane |
| Conventional/standard treatment | Active comparator | Conventional/standard surgery. Receives: Other: Conventional/Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between Day 1 post-surgery and Month 3 post-surgery
Secondary outcomes (29)
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
Measured: Day 0 (the day of the surgery) or Day 1 post-surgery
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
Measured: Visit 1 (7 to 10 days post-surgery)
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
Measured: Visit 2 (14 to 15 days post-surgery)
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
Measured: Visit 3 (One month post-surgery),
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
Measured: Visit 5 (6 months post-surgery)
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
Measured: Visit 6 (12 months post-surgery)
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.
Measured: Day 0 or Day 1 (if hospitalized patient)
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.
Measured: Visit 1 (7 to 10 days post-surgery)
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.
Measured: Visit 2 (14 to 15 days post-surgery)
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.
Measured: Visit 3 ( 1 Month post-surgery)
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.
Measured: Visit 4 (3 Month post-surgery),
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.
Measured: Visit 5 (6 Month post-surgery)
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.
Measured: Visit 6 ( 12 Month post-surgery)
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.
Measured: Day 0 or Day 1 post-surgery (if hospitalized patient)
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.
Measured: visit 1 (7 to 10 days post-surgery)
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.
Measured: Visit 2 (14 to 15 days post-surgery)
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.
Measured: Visit 3 (Month1 post-surgery)
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.
Measured: Visit 4 ( 3 Month post-surgery)
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.
Measured: Visit 5 (6 Month post-surgery)
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.
Measured: Visit 6 (Month 12 post-surgery)
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
Measured: Day 0 or Day +1 post-surgery (if hospitalized patient)
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
Measured: Visit1 (7 to10 days post-surgery)
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
Measured: Visit 2 (14 to 15 days post-surgery)
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
Measured: V3 (Month 1 post-surgery),
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
Measured: Visit 4 ( Month 3 post-surgery)
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
Measured: Visit 5 (Month 6 post-surgery)
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
Measured: Visit 6 (Month 12 post-surgery)
Proportion of subjects with new bone formation
Presence of newly formed bone assessed by cone-beam imaging
Measured: Visit 4 (Month 3)
Proportion of subjects with new bone formation
Presence of newly formed bone assessed by cone-beam imaging
Measured: Visit 5 (Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start22 Sep 2023
- Primary completionSep 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteonecrosis Due to Drugs, JawStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization 3:1
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélien LOUVRIER, MD, PhD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664815
- Sponsor's protocol ID
- 2021/584
- Acronym
- amniOST
- Status last verified
- Sep 2024
- First submitted
- 24 Oct 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05664815
- Acronym / sponsor ID
- amniOST / 2021/584
- Conditions
- Osteonecrosis Due to Drugs, Jaw
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization 3:1
| Arm | Type | Receives |
|---|---|---|
| Application of human amniotic membrane (hAM) | Experimental | Biological: Human Amniotic MembraneAfter conventional/standard treatment, hAM will be applied in a single layer against the bone defect before closure. |
| Conventional/standard treatment | Active comparator | Other: Conventional/Standard treatmentConventional/standard surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Amniotic MembraneAlso: hAM, amnionAfter 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. | Biological | Application of human amniotic membrane (hAM) |
| Conventional/Standard treatmentSurgical 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. | Other | Conventional/standard treatment |
Primary outcome
Number of patients with re-apparition of bone exposure
Time frame: Between Day 1 post-surgery and Month 3 post-surgery
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
29 secondary outcomes
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Time frame: Day 0 (the day of the surgery) or Day 1 post-surgery
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Time frame: Visit 1 (7 to 10 days post-surgery)
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Time frame: Visit 2 (14 to 15 days post-surgery)
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Time frame: Visit 3 (One month post-surgery),
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Time frame: Visit 5 (6 months post-surgery)
Number of patient with re-opening of the scar / reappearance of the bone exposure added visually during the control visit
Time frame: Visit 6 (12 months post-surgery)
To assess pain with Visual Analogue Scale
Time frame: Day 0 or Day 1 (if hospitalized patient)
To assess pain with Visual Analogue Scale
Time frame: Visit 1 (7 to 10 days post-surgery)
To assess pain with Visual Analogue Scale
Time frame: Visit 2 (14 to 15 days post-surgery)
To assess pain with Visual Analogue Scale
Time frame: Visit 3 ( 1 Month post-surgery)
To assess pain with Visual Analogue Scale
Time frame: Visit 4 (3 Month post-surgery),
To assess pain with Visual Analogue Scale
Time frame: Visit 5 (6 Month post-surgery)
To assess pain with Visual Analogue Scale
Time frame: Visit 6 ( 12 Month post-surgery)
Proportion of subjects with a complication at the site of mucosal healing
Time frame: Day 0 or Day 1 post-surgery (if hospitalized patient)
Proportion of subjects with a complication at the site of mucosal healing
Time frame: visit 1 (7 to 10 days post-surgery)
Proportion of subjects with a complication at the site of mucosal healing
Time frame: Visit 2 (14 to 15 days post-surgery)
Proportion of subjects with a complication at the site of mucosal healing
Time frame: Visit 3 (Month1 post-surgery)
Proportion of subjects with a complication at the site of mucosal healing
Time frame: Visit 4 ( 3 Month post-surgery)
Proportion of subjects with a complication at the site of mucosal healing
Time frame: Visit 5 (6 Month post-surgery)
Proportion of subjects with a complication at the site of mucosal healing
Time frame: Visit 6 (Month 12 post-surgery)
quality of life related to oral health
Time frame: Day 0 or Day +1 post-surgery (if hospitalized patient)
quality of life related to oral health
Time frame: Visit1 (7 to10 days post-surgery)
quality of life related to oral health
Time frame: Visit 2 (14 to 15 days post-surgery)
quality of life related to oral health
Time frame: V3 (Month 1 post-surgery),
quality of life related to oral health
Time frame: Visit 4 ( Month 3 post-surgery)
quality of life related to oral health
Time frame: Visit 5 (Month 6 post-surgery)
quality of life related to oral health
Time frame: Visit 6 (Month 12 post-surgery)
Proportion of subjects with new bone formation
Time frame: Visit 4 (Month 3)
Proportion of subjects with new bone formation
Time frame: Visit 5 (Month 6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Bisphosphonate-Associated Osteonecrosis of the Jaw, Osteonecrosis of the Jaw
RecruitingObservational study
Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs
Osteonecrosis of the Jaw, Osteonecrosis Due to Drugs, Jaw
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélien LOUVRIER, MD, PhD principal investigator
CHU de Besançon
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human Amniotic Membrane and Conventional/Standard treatment in people with Osteonecrosis Due to Drugs, Jaw, run by Centre Hospitalier Universitaire de Besancon at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florelle GINDRAUX, PhD (033381218998, fgindraux@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with re-apparition of bone exposure (time frame: Between Day 1 post-surgery and Month 3 post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.