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RECRUITING
NCT06732167
NA

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

Sponsor: Aesculap AG

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

GBR Lyoplant

GBR surgical procedure with simultaneous implant placement including membrane placement

PROCEDURE

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