Clinical Trial

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

Study acronym: LyOral
Recruiting
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Summary
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-06 -> 2027-06 2026-08-04
minor Completion pushed: 2026-12 -> 2027-12 2026-08-04
Trial Details
NCT Number NCT06732167
Lead Sponsor Aesculap AG
Conditions Bone Regeneration
Enrollment 68 participants
Start Date 2025-01-24
Primary Completion 2027-06 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-03