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

Not Applicable

Recruiting

• Conditions: Bone Regeneration

• Registration Number: NCT06732167
• Lead Sponsor: Aesculap AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-13
• Study Start: 2025-01-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• 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.
• The tooth at the implant site must have been extracted or lost at least 8 weeks before the date of bone augmentation (volumetrically healed site).

Exclusion Criteria

• 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.
• Immunocompromised patients.
• Serious disturbances of bone metabolism and/or serious bone diseases of endocrine etiology.
• Medical conditions requiring prolonged use (> 6 months) of steroids and/or ongoing treatment with gluco- and mineralocorticoids and with agents affecting calcium metabolism (e.g. calcitonin), and/or anticoagulative therapy.
• Previous or current use of antiresorptive drugs (ARDs) (e.g. bisphosphonates, selective estrogen receptor modulators (SERMs), denosumab, hormone replacement therapy and calcitonin).
• Previous oral / maxillofacial radiotherapy.
• Heavy smoker (>10 cigarettes/day). In the case of vapors with nicotine, the use of >300 puff vapors (equivalent to 10 cigarettes/day) are not allowed.
• Health conditions, which do not permit the surgical treatment.
• Use of the Investigational Device / Comparator in infected areas.
• Known foreign body sensitivity to implant materials.
• Simultaneous participation in another interventional clinical trial (drugs or medical devices studies) if it could impact the result of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gain of horizontal bone thickness at the augmented site	At Visit 5: 5 months after GBR intervention	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).

Secondary Outcome Measures

Name	Time	Method
Number of side effects	At each follow-up visit: V3 (after 7-14 days), V4 (after 1 month ± 7 days) and V5 (after 5 months ± 2 weeks)	Side effects to be assessed are: * Wound infection; * Wound dehiscence; * Membrane exposure; * Flap sloughing; * Foreign body reaction; * Abscess/pus formation; * Redness/swelling
Number of safety endpoints	At each follow-up visit: V3 (after 7-14 days), V4 (after 1 month ± 7 days) and V5 (after 5 months ± 2 weeks)	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)
Membrane usability	At V2 (surgery): directly after GBR intervention	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.

Trial Locations

Locations (2)

Hospital Odontològic Universitat de Barcelona, Campus Ciències de la Salut de Bellvitge; 🇪🇸 Barcelona, Catalunya, Spain

Clínica Universitaria d.Odontologia de la Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat del Vallés, Catalunya, Spain