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New dental membrane aims to boost bone regeneration in implant surgery

NCT ID NCT06732167

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tests a new collagen membrane called Lyoplant for guided bone regeneration during dental implant surgery. About 68 people who need an implant and have a small bone defect will be randomly assigned to receive either Lyoplant or the standard Bio-Gide membrane. The main goal is to see if Lyoplant is as safe and effective at helping new bone grow, measured by CT scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lyoplant collagen membrane (a barrier membrane used in guided bone regeneration surgery)
What this could lead to
If Lyoplant works as well as Bio-Gide, it could offer dentists another safe option for helping bone grow around dental implants.
What could go wrong
This is a small, early-stage trial with only 68 people, so results may not apply to everyone. There are also risks like infection or membrane exposure, and the study is designed to show non-inferiority, not superiority.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Clínica Universitaria d.Odontologia de la Universitat Internacional de Catalunya

    RECRUITING

    Sant Cugat Del Vallés, Catalonia, 08195, Spain

  • Hospital Odontològic Universitat de Barcelona, Campus Ciències de la Salut de Bellvitge

    RECRUITING

    Barcelona, Catalonia, 08907, Spain

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