Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
ConditionBone Regeneration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAesculap AG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who are willing to give a voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the Informed Consent Form (ICF).
Patients with the capacity to consent for themselves.
Patients in need of an implant with a simultaneous GBR procedure.
Presence of buccal bony dehiscence with a vertical defect height (VDH) ≥ 1 mm and ≤ 6 mm after implant placing.
Disqualifiers
Patients < 18 years.
Currently pregnant or breastfeeding women.
Major systemic diseases (e.g. recent myocardial infarction, cerebrovascular accident or valvular prosthesis surgery, a poorly stabilized diabetes mellitus, severe hypertension, severe peripheral artery occlusive disease, malignancies, autoimmune diseases, or kidney diseases, untreated or uncontrolled periodontal disease, uncontrolled drug or alcohol abuse, uncontrolled psychiatric disorders).
Acute infectious diseases.
Trial design
Design model
Parallel
Treatments tested in this trial
GBR Lyoplant
Procedure/SurgeryGBR surgical procedure with simultaneous implant placement including membrane placement
GBR Bio-Gide
Procedure/SurgeryGBR surgical procedure with simultaneous implant placement including membrane placement
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Lyoplant®Experimental treatment 1 intervention
Group B: Bio-Gide®Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Gain 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 interventionSecondary outcomes
1
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)2
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)3
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 interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov