Bone RegenerationLyOralNCT06732167
Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
A study testing GBR Lyoplant and GBR Bio-Gide in people with Bone Regeneration, run by Aesculap AG at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Regeneration
- What is being tested?
- GBR Lyoplant and GBR Bio-Gide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesSpain
- Study dates
- 24 Jan 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Odontològic Universitat de Barcelona, Campus Ciències de la Salut de Bellvitge
Barcelona, Catalonia, 08907
- Recruiting
Clínica Universitaria d.Odontologia de la Universitat Internacional de Catalunya
Sant Cugat Del Vallés, Catalonia, 08195
About this study
Official title: Prospective, Randomized, Controlled, Multicenter Study on the Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
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
- Bone Regeneration
- Being tested
- GBR Lyoplant, GBR Bio-Gide
- Keywords
- collagen barrier membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBR LyoplantProcedure or surgery
GBR surgical procedure with simultaneous implant placement including membrane placement
GBR Bio-GideProcedure or surgery
GBR surgical procedure with simultaneous implant placement including membrane placement
| Study group | Role | What they receive |
|---|---|---|
| Lyoplant® | Experimental | Not described Receives: Procedure: GBR Lyoplant |
| Bio-Gide® | Active comparator | Not described Receives: Procedure: GBR Bio-Gide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gain of horizontal bone thickness at the augmented site
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).
Measured: At Visit 5: 5 months after GBR intervention
Secondary outcomes (3)
Number of side effects
Side effects to be assessed are:
- Wound infection
- Wound dehiscence
- Membrane exposure
- Flap sloughing
- Foreign body reaction
- Abscess/pus formation
- Redness/swelling
Measured: At each follow-up visit: V3 (after 7-14 days), V4 (after 1 month ± 7 days) and V5 (after 5 months ± 2 weeks)
Number of safety endpoints
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)
Measured: At each follow-up visit: V3 (after 7-14 days), V4 (after 1 month ± 7 days) and V5 (after 5 months ± 2 weeks)
Membrane usability
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.
Measured: At V2 (surgery): directly after GBR intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start24 Jan 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone RegenerationStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732167
- Sponsor's protocol ID
- AAG-G-H-2014
- Acronym
- LyOral
- Status last verified
- Jul 2026
- First submitted
- 9 Dec 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled, Multicenter Study on the Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
- ClinicalTrials.gov ID
- NCT06732167
- Acronym / sponsor ID
- LyOral / AAG-G-H-2014
- Conditions
- Bone Regeneration
- Keywords
- collagen barrier membrane
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lyoplant® | Experimental | Procedure: GBR Lyoplant |
| Bio-Gide® | Active comparator | Procedure: GBR Bio-Gide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GBR LyoplantGBR surgical procedure with simultaneous implant placement including membrane placement | Procedure or surgery | Lyoplant® |
| GBR Bio-GideGBR surgical procedure with simultaneous implant placement including membrane placement | Procedure or surgery | Bio-Gide® |
Primary outcome
Gain of horizontal bone thickness at the augmented site
Time frame: 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).
3 secondary outcomes
Number of side effects
Time frame: At each follow-up visit: V3 (after 7-14 days), V4 (after 1 month ± 7 days) and V5 (after 5 months ± 2 weeks)
Number of safety endpoints
Time frame: At each follow-up visit: V3 (after 7-14 days), V4 (after 1 month ± 7 days) and V5 (after 5 months ± 2 weeks)
Membrane usability
Time frame: At V2 (surgery): directly after GBR intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GBR Lyoplant and GBR Bio-Gide in people with Bone Regeneration, run by Aesculap AG at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Izabela Firkowska-Boden, Dr. (+49 7461 95 ext. 0, studies@aesculap.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gain of horizontal bone thickness at the augmented site (time frame: At Visit 5: 5 months after GBR intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.