Actively Recruiting
Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
Led by Aesculap AG · Updated on 2026-02-27
68
Participants Needed
2
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients willing to give voluntary consent by signing the Informed Consent Form
- Patients with the ability to consent for themselves
- Patients needing a dental implant with a simultaneous guided bone regeneration (GBR) procedure
- Presence of buccal bony dehiscence with vertical defect height between 1 mm and 6 mm after implant placement
- The tooth at the implant site must have been extracted or lost at least 8 weeks before bone augmentation
You will not qualify if you...
- Patients younger than 18 years
- Currently pregnant or breastfeeding women
- Major systemic diseases such as recent heart attack, stroke, valvular prosthesis surgery, poorly controlled diabetes, severe hypertension, severe peripheral artery disease, cancer, autoimmune or kidney diseases, untreated or uncontrolled periodontal disease, uncontrolled drug or alcohol abuse, or uncontrolled psychiatric disorders
- Acute infectious diseases
- Immunocompromised patients
- Serious bone metabolism disturbances or bone diseases of endocrine origin
- Need for prolonged use of steroids or treatments affecting calcium metabolism or anticoagulant therapy
- Previous or current use of antiresorptive drugs like bisphosphonates or hormone therapies
- Previous oral or maxillofacial radiotherapy
- Heavy smokers (more than 10 cigarettes/day) or equivalent nicotine vapor use
- Health conditions preventing surgical treatment
- Use of investigational device or comparator in infected areas
- Known sensitivity to implant materials
- Participation in another interventional clinical trial that could affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospital Odontològic Universitat de Barcelona, Campus Ciències de la Salut de Bellvitge
Barcelona, Catalonia, Spain, 08907
Actively Recruiting
2
Clínica Universitaria d.Odontologia de la Universitat Internacional de Catalunya
Sant Cugat Del Vallés, Catalonia, Spain, 08195
Actively Recruiting
Research Team
I
Izabela Firkowska-Boden, Dr.
CONTACT
T
Tobias Weber, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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