Comparing two toothpastes for dry mouth relief
Official title: Clinical Investigation to Measure the Changes in the Oral Environment Resulting From a 12 Weeks Exposure to an Arginine Containing Toothpaste
Run by Tufts University · NCT06365047 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing two different toothpastes to see which one helps people with dry mouth feel better over three months.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Tufts University Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06365047 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 who are in good health and currently taking medications that cause dry mouth.
✕Probably not a fit
Patients without xerostomia or those not taking medications known to cause dry mouth may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical investigation evaluates the effects of two different toothpastes containing arginine on individuals suffering from xerostomia, or dry mouth. The study employs a double-blind, randomized controlled design involving 70 participants who will be monitored over a three-month period. Participants will undergo oral health evaluations and will be assigned to receive either an 8% arginine toothpaste or a standard fluoride toothpaste. The goal is to measure changes in the oral environment and assess the effectiveness of the treatments.
Why it matters
Potential benefit: If successful, this study could provide an effective toothpaste option for individuals suffering from dry mouth, improving their oral health and quality of life.
How similar studies have gone: Previous studies have shown promising results with arginine-containing products for oral health, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
Tufts University School of Dental Medicine
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Athena Papas, DMD, PhD — Tufts University School of Dental Medicine
- Study coordinator: Athena Papas, DMD, PhD
- Email: dentalresearchadministration@tufts.edu
- Phone: 617-636-3931
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.