Could arginine toothpaste be the answer to dry mouth?
NCT ID NCT06365047
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
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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
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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 Hide 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.
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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