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

Study acronym: amniOST
StatusUnknown
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 19, 2024 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Active, Not Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Apr 2024 to Sep 2025
    • Start date: Aug 8, 2022 to Sep 22, 2023
    • Study sites: 1 to 5
    • Study completion date: Apr 2024 to Mar 2026
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05664815
Lead Sponsor Centre Hospitalier Universitaire de Besancon
Conditions
(from sponsor)		 Osteonecrosis Due to Drugs, Jaw
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov