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Can a thermosensitive gel help gums heal better after deep cleaning?

NCT ID NCT07725913

Disease control Sponsor: University of Bologna 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 24, 2026

Summary

This trial tests whether a gel made from hyaluronic acid and octenidine, placed into deep gum pockets, can improve healing after standard deep cleaning (scaling and root planing) for periodontitis. About 40 adults with moderate to severe gum disease will receive the gel on one side of the mouth and standard cleaning alone on the other, allowing a direct comparison. The main goal is to see if the gel leads to greater pocket depth reduction, a key measure of gum health.

What this could mean

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

Active substance
a thermosensitive hyaluronic acid gel containing octenidine (PX-Gel) applied into periodontal pockets
What this could lead to
If it works, this gel could become a simple add-on to standard gum disease treatment, helping pockets heal faster and reducing the need for more invasive procedures.
What could go wrong
This is a small, early-stage trial with only 40 participants, so results may not apply broadly. The gel is a medical device, not a drug, and its benefit over standard care alone may be modest.

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 40 people

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

Started

Feb 2026

Expected to finish

Feb 2028

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

Accepted

You do not need to have the condition being studied to take part.

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 agreeing to participate in the study * Age 18 years or older * ≥ 20 existing teeth (wisdom teeth excluded). * Diagnosis of periodontitis stage II-III or IV (any grade) of periodontitis * Each participant should have 2 or more contralateral quadrants with a minimum of 4 qualifying pockets of ≥ 5 mm that bled on probing * Full-mouth parallel periapical X-rays demonstrating bone loss (standard of care) Exclusion Criteria: * • Pregnancy (confirmed, suspected, or uncertain), breastfeeding, or intention to become pregnant during the study period * No antibiotic and periodontal therapy within the last 6 months * Heavy smoking (more than 10 cigarettes/day) * Chronic diseases such as uncontrolled diabetes mellitus (HbA1c ≥ 7.0%) or rheumatoid arthritis * History of radiotherapy or chemotherapy * Mucosal immune diseases * Mental disorders * Parafunctional habits such as bruxism * Subjects with removable partial dentures * Patients undergoing orthodontic therapy * Sites next to recent extraction sockets * Teeth showing endodontic-periodontic lesions * Systemically healthy and no known allergies * Subjects with a known hypersensitivity to hyaluronic acid or to any of the ingredients contained in the product formulation.

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Conditions

The condition(s) this trial relates to.

periodontal disorder periodontitis

As listed by the trial registrant

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

Periodontal disease

How to take part

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

  1. The places running it

    2 sites. 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

  • Centro Odontoiatrico Sforza

    RECRUITING

    Bologna, BO, 40124, Italy

  • DIBINEM, Dental Clinic, Periodontology Department, University of Bologna

    RECRUITING

    Bologna, BO, 40125, Italy

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