Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine

NCT ID: NCT06365047

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2028-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

8% Arginine toothpaste

Intervention Type: DEVICE

Investigative

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.

Group Type: ACTIVE_COMPARATOR

1000 ppm F toothpaste

Intervention Type: DRUG

Control

Interventions

8% Arginine toothpaste

Investigative

Intervention Type: DEVICE

1000 ppm F toothpaste

Control

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Athena Papas, DMD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts University School of Dental Medicine

Locations

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

STUDY00004926

Identifier Type: -

Identifier Source: org_study_id