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Tests treatment safety and results for Bone Regeneration
Official title Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
ClinicalTrials.gov ID: NCT06732167
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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).
You likely can't join if
- 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...
- Acute infectious diseases.
- Immunocompromised patients.
- Serious disturbances of bone metabolism and/or serious bone diseases of endocrine etiology.
See the full eligibility 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).
- 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...
- 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...
- 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 treatment clinical trial (drugs or medical devices studies) if it could impact the result of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Catalonia, Spain
- Sant Cugat Del Vallés, Catalonia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Catalonia, Spain; Sant Cugat Del Vallés, Catalonia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.