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New gel could treat implant gum disease without surgery

NCT ID NCT07680491

Disease control Sponsor: Bioteck S.p.A. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests a non-surgical treatment called H42 for people with deep gum pockets around dental implants (peri-implantitis). Half of the 56 participants receive H42, while the other half serve as a control group. Researchers measure pocket depth, plaque, inflammation, pain, and bone changes over three months to see if H42 helps heal the gums and preserve bone.

What this could mean

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

Active substance
H42
What this could lead to
If successful, H42 could offer a non-surgical option to manage peri-implantitis, potentially reducing the need for more invasive procedures.
What could go wrong
This is a small, early-stage study with only 56 participants, so results may not apply broadly. The treatment may not significantly improve pocket depth or bone levels.

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.

Participants

About 56 people

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

Started

Dec 2025

Expected to finish

Sep 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.

Who is studied

Adult patients diagnosed with peri-implantitis and treated at the Department of Stomatology, Faculty of Dentistry, University of Seville, Spain. Participants are recruited from patients seeking care at the university dental clinic and are allocated to the study groups according to the study protocol and predefined inclusion and exclusion criteria. The study evaluates the adjunctive use of H42 hydrogel in the non-surgical treatment of peri-implantitis using a case-control design.

Ages

25 to 65 years

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: * Men or women with age ≥ 25 and ≤ 65 years. * Subjects affected by peri-implant pockets with probing depth (PD) in the range between 6 to 8 mm. * Each subject can have from 1 to 5 defects. * Subjects willing to provide signed informed consent to clinical investigation participation. Exclusion Criteria: * Use of aspirin and antiplatelet agents a week before treatment. * Subjects smokers ≥ 10 cigarettes per day. * Subjects presenting current or previous bleeding disorders. * Subjects taking or having indications for anticoagulant therapy. * Concomitant treatments or procedures to improve gum health over the last six months before the clinical investigation enrolment, such as HA gel treatments, injection of fillers, and surgery. * Subjects suffering from infectious diseases, including herpes simplex infection, active hepatitis, or human immunodeficiency virus. * Subjects with dental aesthetic surgery in the preceding 12 months before the clinical investigation enrolment.

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Conditions

The condition(s) this trial relates to.

Peri-Implantitis

As listed by the trial registrant

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

Peri-implantitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Faculty of Dentistry, University of Seville

    RECRUITING

    Seville, 41009, Spain

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