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

PHASE2RecruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

September 22, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

March 31, 2026

Conditions
Osteonecrosis Due to Drugs, Jaw
Interventions
BIOLOGICAL

Human Amniotic Membrane

"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."

OTHER

Conventional/Standard treatment

"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."

Trial Locations (5)

25030

RECRUITING

CHU de Besancon, Besançon

Unknown

NOT_YET_RECRUITING

CHU Bordeaux Pellegrin, Bordeaux

NOT_YET_RECRUITING

CHU de Dijon, Dijon

NOT_YET_RECRUITING

CHR Metz Thionville, Metz

NOT_YET_RECRUITING

CHU de Reims, Reims

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Besancon

OTHER