NCT06732167 Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
| NCT ID | NCT06732167 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aesculap AG |
| Condition | Bone Regeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2025-01-24 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2025-01-24 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06732167 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bone Regeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06732167 currently recruiting?
Yes, NCT06732167 is actively recruiting participants. Contact the research team at studies@aesculap.de for enrollment information.
Where is the NCT06732167 trial being conducted?
This trial is being conducted at Barcelona, Spain, Sant Cugat Del Vallés, Spain.
Who is sponsoring the NCT06732167 clinical trial?
NCT06732167 is sponsored by Aesculap AG. The trial plans to enroll 68 participants.