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Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
Sponsor: Aesculap AG
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.
Official title: Prospective, Randomized, Controlled, Multicenter Study on the Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2025-01-24
Completion Date
2026-12
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
GBR Lyoplant
GBR surgical procedure with simultaneous implant placement including membrane placement
GBR Bio-Gide
GBR surgical procedure with simultaneous implant placement including membrane placement
Locations (2)
Hospital Odontològic Universitat de Barcelona, Campus Ciències de la Salut de Bellvitge
Barcelona, Catalonia, Spain
Clínica Universitaria d.Odontologia de la Universitat Internacional de Catalunya
Sant Cugat Del Vallés, Catalonia, Spain