Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine

Launched by TUFTS UNIVERSITY · Apr 10, 2024

Keywords

ClinConnect Summary

This clinical trial, called the Dry Mouth Toothpaste Study, is looking at how two different types of toothpaste containing arginine might help people with dry mouth, a condition known as xerostomia. Over a period of three months, participants will use one of the toothpastes, and researchers will evaluate any changes in their oral health. The study is designed to be fair, meaning neither the participants nor the researchers will know which toothpaste each person is using until the end.

To be eligible for this study, you need to be between 18 and 80 years old, in generally good health, and currently taking at least two medications that might cause dry mouth as a side effect. You'll also need to score a certain level of dryness on a scale and have a specific amount of saliva production. If you qualify and choose to participate, you'll receive regular check-ups to monitor your oral health while using the assigned toothpaste. This study is currently recruiting participants, so if you or a loved one are interested, it’s a great opportunity to contribute to research that could help others with similar issues.

Gender

ALL

Eligibility 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).