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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
GBR surgical procedure with simultaneous implant placement including membrane placement
GBR surgical procedure with simultaneous implant placement including membrane placement
Hospital Odontològic Universitat de Barcelona, Campus Ciències de la Salut de Bellvitge
Barcelona, Catalonia, Spain
RECRUITINGClínica Universitaria d.Odontologia de la Universitat Internacional de Catalunya
Sant Cugat Del Vallés, Catalonia, Spain
RECRUITINGGain of horizontal bone thickness at the augmented site
At Visit 2 (V2) and Visit 5 (V5) a Cone Beam Computed Tomography (CBCT) is taken. CBCTs are compared and horizontal bone dimensions at augmented site are measured at four levels (at implant shoulder, 2 mm, 4 mm, and 6 mm from the implant shoulder).
Time frame: At Visit 5: 5 months after GBR intervention
Number of side effects
Side effects to be assessed are: * Wound infection * Wound dehiscence * Membrane exposure * Flap sloughing * Foreign body reaction * Abscess/pus formation * Redness/swelling
Time frame: At each follow-up visit: V3 (after 7-14 days), V4 (after 1 month ± 7 days) and V5 (after 5 months ± 2 weeks)
Number of safety endpoints
Safety endpoints to be assessed are: * Device related adverse events (adverse device effects (ADE) * Seriousness of device related adverse events (serious adverse device effect (SADE)) * Device deficiency (DD)
Time frame: At each follow-up visit: V3 (after 7-14 days), V4 (after 1 month ± 7 days) and V5 (after 5 months ± 2 weeks)
Membrane usability
The usability of Lyoplant® and Bio-Gide® membranes will be evaluated by completing a survey regarding the handling of these membranes (measured on a 5-point Likert scale) by the Investigator.
Time frame: At V2 (surgery): directly after GBR intervention
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