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Gum disease breakthrough? new trial tests growth factors to regrow bone

NCT ID NCT05858411

Disease control Sponsor: G. d'Annunzio University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding special proteins or blood-based membranes to deep cleaning helps repair bone and gum damage from advanced gum disease. 88 adults with deep gum pockets and bone loss will receive one of three treatments or cleaning alone. Researchers will measure bone and gum healing over 12 months.

What this could mean

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

Active substance
recombinant human platelet-derived growth factor (rhPDGF), leukocyte-platelet rich fibrin (L-PRF), enamel matrix derivatives (EMD)
What this could lead to
If successful, these treatments could improve bone and gum attachment repair after deep cleaning for people with advanced gum disease.
What could go wrong
This is a small, early-stage trial (88 people) comparing several treatments. Results may not apply to all patients, and the added benefit over cleaning alone is uncertain.

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 88 people

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

Started

Jan 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 with a diagnosis of periodontitis stage III or IV (grades A to C), * non-smokers or former smokers who quit at least 1 year ago, and * had not received any periodontal treatment in the 3 months prior to recruitment; * Presence of at least 1 Infrabony defect (PPD ≥ 5 mm with infrabony defect depth of ≥3mm at screening radiograph); * One and two wall infrabony defects at screening radiograph and periodontal charting. * Signed informed consent. Exclusion Criteria: * Presence of uncontrolled systemic diseases that could affect treatment outcomes such as diabetes mellitus with an HbA1C\>7%, rheumatoid arthritis or any form of immunosuppression; * Subjects requiring antibiotic prophylaxis; * 3-wall infrabony defects; * Patients that had received systemic or local delivery of antibiotic therapy 6 weeks before enrollment; * Presence of furcation defect; * Chronic intake of NSAIDs or steroids, currently; * Patients undergoing orthodontic treatment, having removable prosthetic appliances, pregnancy, tumors of the oral cavity or the presence of any psychiatric condition that could affect participation.

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Conditions

The condition(s) this trial relates to.

Periodontal Attachment Loss periodontal disorder Periodontal Pocket periodontitis

As listed by the trial registrant

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

Intrabony periodontal defect Periodontal attachment loss Periodontal diseases Pocket, periodontal

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

  • University of Medicine of Tirana

    RECRUITING

    Tirana, Albania

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