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Could arginine toothpaste be the answer to dry mouth?

NCT ID NCT06365047

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether an arginine-containing toothpaste can change the acidity of saliva in people with dry mouth caused by medications. Seventy adults will use either the arginine toothpaste or a regular fluoride toothpaste for 12 weeks. Researchers will measure saliva pH and mouth bacteria to see if the toothpaste helps balance the oral environment.

What this could mean

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

Active substance
8% arginine toothpaste
What this could lead to
If it works, this could point toward a simple, daily way to ease dry mouth discomfort for people taking multiple medications.
What could go wrong
This is a small, early-phase trial focused on mouth chemistry, not symptoms directly. The toothpaste may not meaningfully improve dryness or quality of life.

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

70 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Jun 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 80 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. Male or female volunteers 18- 80 years of age and in general good health. 2. Willing and able to understand and sign the informed consent form. 3. Subjects currently taking at least two medications known to cause xerostomia (dry mouth) as a side effect for the last three months. 4. Be willing to conform to the study protocol and procedures. 5. Polypharmacy subjects must score 4 or more on the VAS scale of 0-10 ("How severe is your dryness right now?"). 6. Flow of 5 minutes unstimulated saliva should be below 0.16 ml/min. 7. No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner. 8. Minimum of 10 teeth Exclusion Criteria: 1. Subjects unable to understand or unwilling to sign the informed consent form. 2. Medical condition which requires premedication prior to dental visits/procedure. 3. Active disease of the hard or soft oral tissues. 4. History of salivary gland disease such as Sjogren's syndrome, Sarcoidosis, or Head and Neck Radiation Therapy. 5. Use of antibiotics or antimicrobial drugs within 30 days prior to study start. 6. Participation in any other clinical study within 1 week prior to enrollment into this study. 7. Subjects who must receive dental treatment during the study dates. 8. Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy). 9. Presence of orthodontic bands. 10. Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1) 11. Use of pilocarpine or other cholinergic stimulating receptor actives prescribed after study enrollment or whose medication dose increases (stable dose for 3 months). 12. People on hormone therapy 13. Pregnant or lactating subjects. 14. Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits; 15. Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).

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Conditions

The condition(s) this trial relates to.

Xerostomia

As listed by the trial registrant

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

Contacts and locations

Locations

  • Tufts University School of Dental Medicine

    Boston, Massachusetts, 02111, United States

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