66
Participants
Start Date
September 22, 2023
Primary Completion Date
September 30, 2025
Study Completion Date
March 31, 2026
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."
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."
RECRUITING
CHU de Besancon, Besançon
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
Centre Hospitalier Universitaire de Besancon
OTHER