Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-01 @ 11:57 PM
Study NCT ID:
NCT06732167
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2024-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
Sponsor:
Aesculap AG
Organization:
Study Overview
Official Title:
Prospective, Randomized, Controlled, Multicenter Study on the Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LyOral
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: