Gum gel shows promise in reducing deep gum pockets
NCT ID NCT07592377
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
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38 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Dec 2024
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Studio Brecodent
Dongo, Como, 22014, Italy
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Studio Parma Benfenati
Ferrara, Ferrara, 44121, Italy
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