Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine

Last updated: November 18, 2024
Sponsor: Tufts University
Overall Status: Active - Recruiting

Phase

3

Condition

Saliva And Salivary Gland Dysfunction

Dry Mouth

Treatment

Tom's of Maine Rapid Relief toothpaste

1000 ppm F toothpaste

8% Arginine toothpaste

Clinical Study ID

NCT06365047
STUDY00004926
  • Ages 18-80
  • All Genders

Study Summary

This is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste. This study is a double blind, randomized controlled, parallel design. Seventy (70) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following oral health evaluations, subjects will be assigned to the treatment schedule and receive their assigned study product.

Eligibility Criteria

Inclusion

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 (drymouth) 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 isyour 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 studyexaminer.

  8. Minimum of 10 teeth

Exclusion

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 Headand 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 intothis 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 toVisit 1)

  11. Use of pilocarpine or other cholinergic stimulating receptor actives prescribedafter study enrollment or whose medication dose increases (stable dose for 3months).

  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 (Hepatitisseries, HIV, tuberculosis).

Study Design

Total Participants: 70
Treatment Group(s): 4
Primary Treatment: Tom's of Maine Rapid Relief toothpaste
Phase: 3
Study Start date:
August 31, 2024
Estimated Completion Date:
June 01, 2027

Connect with a study center

  • Tufts University School of Dental Medicine

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

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