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Collagen gel could offer a Needle-Free fix for gum disease

NCT ID NCT07700628

Disease control Sponsor: Studio Odontoiatrico Dott. G. Tarquini Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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

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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study investigates whether a collagen hydrogel called H42 can help treat deep gum pockets caused by periodontitis or peri-implantitis. Researchers will measure changes in pocket depth, plaque, gum attachment, and bleeding over 90 days in adults aged 25 to 65 with 1 to 5 gum defects. The study also tracks pain and healing after treatment. It is a retrospective review of how H42 was used in standard practice, not a controlled experiment.

What this could mean

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

Active substance
a collagen hydrogel medical device called H42
What this could lead to
If successful, H42 could offer a simple, non-surgical option to reduce gum pocket depth and improve gum health in people with periodontitis or peri-implantitis.
What could go wrong
This is a small, retrospective study without a control group, so results may not prove effectiveness. The device is new and long-term benefits or risks are unknown.

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

52 people

The number who actually took part.

Started

Jun 2022

Finished

Apr 2023

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.

Who is studied

Adult subjects aged 25 to 65 years with peri-implant or periodontal pockets with probing depths (PD) between 5 and 8 mm and 1-5 defects, treated with H42 according to standard clinical practice in three dental clinics located in Italy.

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: 1. Adults aged 25 years ≤ age ≤ 65 years. 2. Subjects with peri-implant or periodontal pockets with probing depths (PD) between 5 and 8 mm. 3. Subjects with 1-5 defects. 4. Subjects willing to provide signed informed consent to participate in the clinical study. Exclusion Criteria: 1. Use of aspirin and/or antiplatelet agents one week prior to treatment. 2. Smokers (≥10 cigarettes per day). 3. Use of concomitant treatments or procedures aimed at improving gum health within the last six months prior to enrollment in the clinical trial, such as treatments with HA gel, filler injections, or surgical procedures. 4. Subjects with infectious diseases, including infection with the herpes simplex virus, active hepatitis, or the human immunodeficiency virus. 5. Subjects who have undergone cosmetic dental surgery within the previous 12 months.

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Conditions

The condition(s) this trial relates to.

Peri-Implantitis Periodontal Pocket periodontitis

As listed by the trial registrant

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

Peri-implantitis Periodontal pocket

Contacts and locations

Locations

  • Studi Odontoiatrici Papa e Di Stefano

    Caserta, CE, 81100, Italy

  • Studio Odontoiatrico Dott. G. Tarquini

    Roma, RM, 00179, Italy

  • Studio odontoiatrico Sao di De Rosa Nicola e Del Giudice Marina

    Naples, 80122, Italy

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