Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine

NCT06365047 | Active Not Recruiting Phase 3 FDA Drug FDA Device

• 1 other identifier: STUDY00004926
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measuring the change in the oral microbiome

  12 weeks

Study Arms (2)

Investigative Arm- Using an 8% Arginine toothpaste

EXPERIMENTAL

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

Control Arm- a 1000 ppm F toothpaste

ACTIVE COMPARATOR

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

Interventions

1000 ppm F toothpaste DRUG

Control

Control Arm- a 1000 ppm F toothpaste

8% Arginine toothpaste DEVICE

Investigative

Investigative Arm- Using an 8% Arginine toothpaste

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female volunteers 18- 80 years of age and in general good health.
• Willing and able to understand and sign the informed consent form.
• Subjects currently taking at least two medications known to cause xerostomia (dry mouth) as a side effect for the last three months.
• Be willing to conform to the study protocol and procedures.
• Polypharmacy subjects must score 4 or more on the VAS scale of 0-10 ("How severe is your dryness right now?").
• Flow of 5 minutes unstimulated saliva should be below 0.16 ml/min.
• 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.
• Minimum of 10 teeth

You may not qualify if:

• Subjects unable to understand or unwilling to sign the informed consent form.
• Medical condition which requires premedication prior to dental visits/procedure.
• Active disease of the hard or soft oral tissues.
• History of salivary gland disease such as Sjogren's syndrome, Sarcoidosis, or Head and Neck Radiation Therapy.
• Use of antibiotics or antimicrobial drugs within 30 days prior to study start.
• Participation in any other clinical study within 1 week prior to enrollment into this study.
• Subjects who must receive dental treatment during the study dates.
• Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).
• Presence of orthodontic bands.
• Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1)
• Use of pilocarpine or other cholinergic stimulating receptor actives prescribed after study enrollment or whose medication dose increases (stable dose for 3 months).
• People on hormone therapy
• Pregnant or lactating subjects.
• Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits;
• Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).

Sponsors & Collaborators

• Tufts University: lead
• Colgate Palmolive: collaborator

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Athena Papas, DMD, PhD

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: August 31, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)