NCT06732167

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

Prospective, Randomized, Controlled, Multicenter Study on the Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Regeneration

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-01-24
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-12-13
• Last updated: 2026-02-27

Locations

2 sites across 1 country: Spain