Gum gel shows promise in reducing deep gum pockets

NCT ID NCT07592377

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a collagen-based gel called H42 in 38 adults with gum disease (periodontitis). The gel was placed into deep gum pockets after standard cleaning. Researchers measured how much pocket depth decreased over 12 weeks, along with other signs of gum health and patient comfort.

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Study facts

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

Participants

38 people

The number who actually took part.

Started

Feb 2024

Finished

Dec 2024

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

The dataset includes 153 observations related to 38 subjects, with multiple observations per subject due to different tooth positions. The study was conducted in two dental clinics located in Italy.

Ages

18 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 between 18 and 65 years. * Stage 3 generalized periodontitis * Subjects affected by periodontal pockets with probing depth (PD) in the range between 5 to 8 mm * For each subject a maximum of 5 defects were evaluated. If the patient presented more defects, at the beginning of the study the investigator identified the "target" lesions. * Subjects who followed in the previous two weeks instructions to oral hygiene (proper brushing techniques twice a day, proper flossing technique daily). * Subjects able to communicate adequately with the Investigator and to comply with the requirements for the entire study. * The decision to prescribe H42® as an adjunctive therapy for the condition was entirely independent of that of including the patient in the study. * Subjects or legal representatives had to be willing and able to give informed consent/assent for participation in the study. Exclusion Criteria: * Subjects presenting current or previous bleeding disorders. * Subjects taking or having indications for anticoagulant therapy. * Use of aspirin and antiplatelet agents within one week prior to treatment. * Subjects with history of allergy or hypersensitivity to the tested device or to its ingredients, or hypersensitivity skin reaction to the investigational device, or at risk in term of precautions, warnings and contra-indications referred in the package insert of the clinical investigation device. * Use of concomitant treatments or procedures aimed to improve gums health over the last six months before the clinical investigation enrolment, such as HA gel treatments, injection of fillers, surgery. * Subjects unlikely to cooperate in the clinical investigation or with the clinical investigation visits. * Pregnant or lactating women, or women of childbearing potential planning a pregnancy during the study. * Subjects with illness, or other medical condition that, in the opinion of the investigator, would have compromised participation, or that would likely have resulted in hospitalization during the study (e.g., epilepsy), or predisposed to infections (e.g. HIV infection, acute hepatitis), or jeopardized the evaluation of the study results (e.g. herpes virus infection). * Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days. * Any reason, according to Investigator's judgement, able to compromise compliance with procedures outlined in the study protocol or making participation in the study not advisable, was considered.

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Conditions

The condition(s) this trial relates to.

Inflammation Periodontal Pocket periodontitis

As listed by the trial registrant

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

Contacts and locations

Locations

  • Studio Brecodent

    Dongo, Como, 22014, Italy

  • Studio Parma Benfenati

    Ferrara, Ferrara, 44121, Italy

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