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New mouthwash could fight gum disease without antibiotics

NCT ID NCT07402694

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a new mouthwash called Amphion can improve gum health when used after standard deep cleaning for periodontitis. Sixty adults with gum disease will receive either Amphion or a placebo mouthwash to use at home twice daily. The goal is to see if the mouthwash reduces plaque and gum bleeding better than cleaning alone.

What this could mean

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

Active substance
Amphion mouthwash
What this could lead to
If it works, this could provide a new, antibiotic-free mouthwash option to help control plaque and gum inflammation after standard dental cleanings.
What could go wrong
This is a small, early-stage Phase 4 trial with only 60 participants. The mouthwash may not significantly improve outcomes over placebo, and long-term safety or effectiveness is not yet established.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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 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. Aged between 18 and 65 years old. 2. At least 20 natural teeth (excluding root remnants) present in the oral cavity. 3. Diagnosed with Stage I-IV periodontitis according to the 2018 new classification of periodontal diseases. 4. No impairment in vision, motor function, or cognitive ability, capable of understanding and cooperating with the study. 5. Not undergoing any orthodontic treatment and not wearing removable partial dentures during the study period. 6. Fully informed and voluntarily signed a written informed consent form. Exclusion Criteria: 1. Individuals allergic to any component used in the study. 2. Pregnant or lactating women. 3. Those who have undergone periodontal treatments such as scaling, root planing, or used antimicrobial mouthwash within the past 3 months. 4. Those with a history of systemic hormone or antibiotic use within the past 3 months, or who are assessed as requiring adjunctive use of such medications during periodontal treatment. 5. Individuals with underlying systemic diseases that may affect the evaluation of periodontal status, including but not limited to: abnormal liver function, renal insufficiency, hematological diseases, neurological or psychiatric disorders, systemic bone diseases, diabetes, coronary heart disease, malignant tumors, etc. 6. Current or former smokers (including active or passive smoking), or users of other nicotine and tobacco products (such as e-cigarettes, chewing tobacco).

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Conditions

The condition(s) this trial relates to.

periodontitis

As listed by the trial registrant

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

Mouthwash Periodontitis

How to take part

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

  1. The places running it

    1 site. 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

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000, China

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