A Phase 2 interventional study of Human Amniotic Membrane and Conventional/Standard treatment in Osteonecrosis Due to Drugs, Jaw, sponsored by Centre Hospitalier Universitaire de Besancon. Recruiting at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Centre Hospitalier Universitaire de Besancon · Phase 2, Interventional, and Treatment
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.
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.
286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.
This study's planned enrollment of 66 is close to the median of 68 across 151 interventional studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 450 studies on the registry; 97 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
NON-INCLUSION CRITERIA
EXCLUSION CRITERIA
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After conventional/standard treatment, hAM will be applied in a single layer against the bone defect before closure.
Biological: Human Amniotic Membrane
Conventional/standard surgery.
Other: Conventional/Standard treatment
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.
Also known as: hAM, amnion
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.
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
Time frame: Between Day 1 post-surgery and Month 3 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
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
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)
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
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
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),
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
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
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Visit 6 (Month 12 post-surgery)
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
Time frame: 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
Time frame: Visit1 (7 to10 days post-surgery)
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
Time frame: 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
Time frame: V3 (Month 1 post-surgery),
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
Time frame: Visit 4 ( Month 3 post-surgery)
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
Time frame: Visit 5 (Month 6 post-surgery)
quality of life related to oral health
Oral health impact profile OHIP 14 quality of life score
Time frame: Visit 6 (Month 12 post-surgery)
Proportion of subjects with new bone formation
Presence of newly formed bone assessed by cone-beam imaging
Time frame: Visit 4 (Month 3)
Proportion of subjects with new bone formation
Presence of newly formed bone assessed by cone-beam imaging
Time frame: Visit 5 (Month 6)
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