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Gel could soothe sore gums and reverse early recession

NCT ID NCT07577258

Disease control Sponsor: Nakhia Impex LLC 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether a gel made from a special form of hyaluronan (HA35) can help people with mild gum recession and chronic gum inflammation. Thirty adults will apply the gel to their gums and teeth twice a day for 42 days. Researchers will measure changes in gum recession depth, pain, redness, swelling, and bleeding to see if the gel is safe and effective.

What this could mean

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

Active substance
10% 35 kDa hyaluronan (HA35) gel
What this could lead to
If it works, this gel could offer a simple, non-invasive way to manage mild gum recession and inflammation at home.
What could go wrong
This is a very early, small pilot study with only 30 people and no comparison group. Results may not apply to everyone, and the gel may not work as hoped.

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 30 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Aug 2026

An estimate. End dates often move.

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.

Ages

18 to 60 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: * Age 18-60 years, male or female * Clinically diagnosed with mild gingival recession (Miller Class I or II) * Chronic gingival pain, redness, swelling, or brushing-induced bleeding * Ability to complete self-assessments and comply with 42-day intervention * Signed written informed consent Exclusion Criteria: * Severe periodontitis, tooth mobility, or alveolar bone loss * Uncontrolled diabetes or immune dysfunction * Use of prescription periodontal medications within 2 weeks * Known hypersensitivity to hyaluronan or gel components * Oral infection, ulceration, or severe mucosal injury * Pregnant or lactating women

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Conditions

The condition(s) this trial relates to.

chronic periodontitis Gingival Hemorrhage gingival recession gingivitis periodontal disorder periodontitis

As listed by the trial registrant

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

Chronic gingival pain Gingival bleeding Gingival redness and swelling Mild gingival recession Periodontal inflammation

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

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