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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Besancon

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Human Amniotic Membrane

    Biological/Vaccine

    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 treatment

    Other intervention

    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.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Application of human amniotic membrane (hAM)Experimental treatment 1 intervention
Group B: Conventional/standard treatmentActive comparator 1 intervention

Trial outcomes

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

Time frame
Between Day 1 post-surgery and Month 3 post-surgery

Secondary outcomes

1

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
2

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)
3

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)
4

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),

Other outcomes

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