amniOST
Benefit of Cryopreserved Human Amniotic Membrane (hAM) on Oral Mucosal Healing Among Patients With Stage II Maxillomandibular Osteonecrosis Induced by Antiresorptive and/or Anti-angiogenic Therapies: a Phase II Randomized Trial
Sponsor study identifier
interventional
66
1 country
5
Study Start
September 22, 2023
Actual (reported)Primary Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 24, 2022
Actual (reported)December 27, 2022
Actual (reported)September 22, 2023
Actual (reported)September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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)
After conventional/standard treatment, hAM will be applied in a single layer against the bone defect before closure.
Conventional/standard surgery.
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.
CHU de Besancon
Besançon, 25030, France
CHU Bordeaux Pellegrin
Bordeaux, France
Aurélien LOUVRIER, MD, PhD
CHU de Besançon
First Submitted
October 24, 2022
First Posted
December 27, 2022
Study Start
September 22, 2023
Actual (reported)Primary Completion
September 2025
Estimated (date passed)Medical and Surgical Treatment of MRONJ (Medication-related Osteonecrosis of the Jaw Bones)
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.
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CHU de Dijon
Dijon, France
CHR Metz Thionville
Metz, France
CHU de Reims
Reims, France
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 19, 2024
Record last verified: 2024-09
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Source: ClinicalTrials.gov.
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