Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Xerostomia
• Intervention / Treatment: Device: 8% Arginine toothpaste; Drug: 1000 ppm F toothpaste

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Athena Papas, DMD, PhD; Phone Number: 617-636-3931; Email: dentalresearchadministration@tufts.edu
• Study Contact Backup: Name: Ann-Marie Billig; Phone Number: 6173632408; Email: dentalresearchadministration@tufts.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigative Arm- Using an 8% Arginine toothpaste; For the study period (12 weeks), subjects in the Investigative Arm will be instructed to brush their teeth with an 8% Arginine toothpaste.	Device: 8% Arginine toothpaste; Investigative
Active Comparator: Control Arm- a 1000 ppm F toothpaste; For the study period (12 weeks), subjects in the Control Arm will be instructed to brush their teeth with Control Arm- a 1000 ppm F toothpaste.	Drug: 1000 ppm F toothpaste; Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Colgate Palmolive
• Investigators: Principal Investigator: Athena Papas, DMD, PhD, Tufts University School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: STUDY00004926

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No