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Could a chitosan toothpaste beat cavity protection? new trial aims to find out

NCT ID NCT07499115

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial will test whether a toothpaste containing chitosan, a natural substance, can reduce plaque, gingivitis, and gum bleeding better than a standard fluoride toothpaste. About 90 adults aged 18-70 with good general health will brush with either the chitosan toothpaste or a regular fluoride toothpaste for a set period. Researchers will measure gum inflammation, plaque levels, and bleeding to see if the chitosan formula offers extra benefits for daily oral care.

What this could mean

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

Active substance
chitosan toothpaste
What this could lead to
If it works, this could offer a new option for improving daily oral hygiene and reducing gum inflammation.
What could go wrong
This is a small, early-stage Phase 3 trial with only 90 participants, so results may not apply to everyone. Chitosan toothpaste may not prove significantly better than standard fluoride toothpaste.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 90 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jul 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 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Male or female, aged 18-70 years (inclusive). * Available for the duration of the study. * Able to understand and willing to read and sign the Informed Consent Form after the nature of the study has been fully explained. * Willing to comply with all study procedures and clinical examination schedules. * Good general health (absence of any condition that, in the opinion of the study examiner, might pose risk during participation; e.g., certain heart conditions, valve/hip replacements). * Presence of at least 20 natural teeth (excluding third molars) with scorable facial and lingual surfaces. * Mean Modified Gingival Index (MGI, Lobene) ≥ 2.0 and Mean Modified Plaque Index (MPI, Turesky) ≥ 1.5 at screening. * Willing and able to complete study questionnaires on product usage experience during routine toothbrushing. Exclusion Criteria: * Pregnant or lactating. * Use of tobacco products. * History of alcohol or drug abuse. * Any medical condition (e.g., significant heart or liver disease, bleeding disorders, blood dyscrasias) or current medication use that, in the investigator's judgment, may compromise subject safety or the quality of study results. * Medical condition requiring pre-medication prior to dental visits/procedures. * History of allergy to oral hygiene products. * Use of anti-inflammatory, immunosuppressive, antimicrobial, or anticoagulant drugs, or antibiotics within 30 days prior to study start or during the study. * Ongoing use of medications known to affect gingival tissues (e.g., calcium channel blockers, phenytoin, cyclosporine). * Presence of orthodontic bands or removable partial dentures. * Tumors of the soft or hard tissues of the oral cavity. * Five or more carious lesions requiring immediate restorative treatment. * More than two periodontal pockets (\>4 mm) with bleeding on probing. * Any gingival condition (e.g., hyperplasia or overgrowth) that would interfere with clinical assessment. * Participation in another clinical study with an oral care indication or test panel within 30 days prior to study start. * Medical condition that prohibits abstaining from eating or drinking for up to 2 hours.

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Conditions

The condition(s) this trial relates to.

Dental Plaque gingivitis

As listed by the trial registrant

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

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

  • West China Dental Institute of Chengdu

    Chengdu, Sichuan, 610041, China

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Other studies related to the condition(s) this trial covers.