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Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery

Study acronym: LyOral
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jun 2026 → Jun 2027
See other at-risk trials from Aesculap AG

Record History

  1. Notable Primary completion pushed from Jun 2026 to Jun 2027 Completion pushed from Dec 2026 to Dec 2027v5 Show 1 more changeShow less
    • Completion pushed from Dec 2026 to Dec 2027
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Minor Start date changed from estimate of Jan 2025 to Jan 24, 2025v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date: Dec 2024 to Jan 2025 · Interventions: GBR (Procedure), GBR (Procedure) to GBR Bio-Gide (Procedure), GBR Lyoplant (Procedure)v2 Show 3 more changesShow less
    • Study sites: 0 to 2
    • Start date: Dec 2024 to Jan 2025
    • Interventions: GBR (Procedure), GBR (Procedure) to GBR Bio-Gide (Procedure), GBR Lyoplant (Procedure)
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
32 trials monitored
See 6 trials at risk
Guided Bone Regeneration (GBR) is a well-established surgical technique that employs barrier membranes to ensure the stability of bone augmentation material while preventing the infiltration of soft tissue, thereby facilitating new bone formation. The primary objective of this randomized controlled trial is to assess the performance and safety of the Lyoplant® collagen membrane as a barrier membrane in GBR for patients undergoing dental implant surgery. Additionally, the study aims to compare the Lyoplant® membrane with the Bio-Gide® collagen membrane, with the goal of demonstrating the non-inferiority of the Lyoplant® membrane in terms of radiographically measured bone gain compared to the comparator.
Trial Details
NCT Number NCT06732167
Lead Sponsor Aesculap AG
Conditions Bone Regeneration
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov