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

NCT05664815 | Recruiting Phase 2 DMC

• 1 other identifier: 2021/584
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 5

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.

Conditions

Osteonecrosis Due to Drugs, Jaw

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  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

  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

  Visit 5 (6 months post-surgery)

Study Arms (2)

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.

Biological: Human Amniotic Membrane

Conventional/standard treatment

ACTIVE COMPARATOR

Conventional/standard surgery.

Other: Conventional/Standard treatment

Interventions

Human Amniotic Membrane BIOLOGICAL

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

Application of human amniotic membrane (hAM)

Conventional/Standard treatment OTHER

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.

Conventional/standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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, 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
• 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,…)

You may not qualify 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (5)

CHU de Besancon

Besançon, 25030, France

RECRUITING

CHU Bordeaux Pellegrin

Bordeaux, France

NOT YET RECRUITING

CHU de Dijon

Dijon, France

NOT YET RECRUITING

CHR Metz Thionville

Metz, France

NOT YET RECRUITING

CHU de Reims

Reims, France

NOT YET RECRUITING

MeSH Terms

Interventions

cancer procoagulant; Congresses as Topic

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Aurélien LOUVRIER, MD, PhD

  CHU de Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florelle GINDRAUX, PhD

CONTACT

033381218998; fgindraux@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization 3:1

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: December 27, 2022
• Study Start: September 22, 2023
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (5)