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Could a toothpaste ingredient reshape the microbes behind gum disease?

NCT ID NCT07755800

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This trial tests whether a toothpaste containing arginine can alter the bacteria living below the gumline in people with gum disease who are already receiving ongoing dental care. Participants will brush twice daily for six months with either an arginine toothpaste or a standard fluoride toothpaste. Researchers will collect plaque samples at the start, at three months, and at six months to compare how the microbial community changes between the two groups.

What this could mean

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

Active substance
Arginine toothpaste
What this could lead to
If arginine toothpaste shifts the bacteria below the gumline in a favorable way, it could become a simple daily aid for managing gum disease alongside professional care.
What could go wrong
This is an early-stage study, and changes in bacteria may not translate into better gum health. Results may vary, and the trial does not test for long-term outcomes.

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 108 people

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

Started

Aug 2026

Expected to finish

Jul 2028

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 95 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: * Understands and is willing to sign an Informed Consent, approved by the local Ethics Committee. * Female or male, ages 18-95 years old (inclusive) * Systemically healthy. * Presence of at least three evaluable teeth in each quadrant. * Moderate gingival inflammation, with at least a 10% of bleeding on probing (BOP) will be required together with moderate level of plaque. * No Grade 3 Tooth Mobility * Treated stage II or III periodontitis patients, whose active treatment has finalized more than 6 months before. Stage II - Interdental clinical attachment level (CAL) at the site of greatest loss equal to 3 to 4 millimeters with maximum probing depth of less than or equal to 5 millimeters. Stage III - Interdental CAL at the site of greatest loss greater than equal to 5 millimeters, probing depth (PD) greater than or equal to 6 millimeters, and radiographic vertical bone loss * Enrolled in a periodontal maintenance treatment program * No orthodontic banding (no permanent retainers, no orthodontic appliances (i.e., no removable plastic/metal retainer) or removable prosthesis (no removable partial and/or full denture). * Subjects willing to participate and comply with the requirements of the study. * Subjects that brush their teeth regularly (once or twice daily). * Able to travel to and attend 4 research study visits over the span of the next 6 months. * Able to independently provide consent for oneself. * Fluent in reading, comprehending, and speaking English without assistance from a translator. * If a patient is using prevident, they must be willing to stop using it. Exclusion Criteria: * Untreated or uncontrolled periodontitis or advanced (advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss) * Antibiotics intake within the previous month. * Pregnant women and/or breastfeeding women * Any adverse medical history (controlled and uncontrolled diabetes, osteoporosis, immunosuppression…) or long-term medication (chemotherapy and immunosuppression treatment; pharmacological treatment associated with gingival overgrowth such as the use of phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, amlodipine, verapamil, cyclosporine) influencing gingival conditions. * Conditions which require antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis…). * Not willing to comply with the study protocol recommendation and visit schedule. * Current smokers or those using tobacco or vaping products. * Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care * Currently participating in another clinical research study now and/or within the past month. * Has a history of allergies to oral care or personal care consumer products or their ingredients * Has an existing medical condition that prohibits eating or drinking for periods up to 4 hours. * Any ongoing medical condition that makes a subject unsuitable for enrollment-or any new diagnosis that arises during the study that makes the subject unsuitable to continue-may lead to exclusion, as determined by the Principal Investigator on a case by case basis. Conditions that may result in exclusion include, but are not limited to: 1. Recent myocardial infarction 2. Recent cerebrovascular accident 3. Recent placement of a cardiac valvular prosthesis 4. Severe liver dysfunction 5. Known or suspected current malignancy 6. New antibiotic use 7. Note: The Principal Investigator will review all available information about the subject and make decisions regarding both enrollment and/or continued participation.

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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.

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

    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 ↗

  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 University of Iowa College of Dentistry

    Iowa City, Iowa, 52242, United States

More trials for these conditions

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