Evaluating the safety and effectiveness of Lyoplant® collagen membrane in dental bone regeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the performance and safety of the Lyoplant® collagen membrane as a barrier in Guided Bone Regeneration (GBR) during dental implant surgery. It will compare the Lyoplant® membrane with the established Bio-Gide® collagen membrane to determine if Lyoplant® is non-inferior in promoting bone gain. The study involves patients who require bone augmentation due to specific defects after tooth extraction. Participants will be monitored for radiographic outcomes to evaluate bone regeneration.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Odontològic Universitat de Barcelona, Campus Ciències de la Salut de Bellvitge
  Barcelona, Catalonia, Spain Recruiting
• Clínica Universitaria d.Odontologia de la Universitat Internacional de Catalunya
  Sant Cugat Del Vallés, Catalonia, Spain Recruiting

Study contacts

• Study coordinator: Izabela Firkowska-Boden, Dr.
• Email: studies@aesculap.de
• Phone: +49 7461 95

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.