Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine

Xerostomia Clinical Trial

Official title:

Clinical Investigation to Measure the Changes in the Oral Environment Resulting From a 12 Weeks Exposure to an Arginine Containing Toothpaste

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365047
• Other study ID #: STUDY00004926
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2024
• Est. completion date: June 1, 2027

Study information

• Verified date: June 2024
• Source: Tufts University
• Contact: Athena Papas, DMD, PhD
• Phone: 617-636-3931
• Email: dentalresearchadministration[@]tufts.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Xerostomia

Intervention

Device:
• 8% Arginine toothpaste
Investigative

Drug:
• 1000 ppm F toothpaste
Control

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary pH Impact	The objective of this clinical research study is to determine if the use of an Arginine containing toothpaste alters the salivary pH of people with xerostomia.	12 weeks
Secondary	Measuring the change in the oral microbiome	The objective of this clinical research study is to determine if the use of an Arginine containing toothpaste alters the oral microbiome (salivary and whole mouth plaque) of people with xerostomia.	12 weeks