Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine

Tufts University

Status and phase: Enrolling; Phase 3

Conditions: Xerostomia

Treatments: Drug: 1000 ppm F toothpaste; Device: 8% Arginine toothpaste

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06365047

STUDY00004926

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups

Investigative Arm- Using an 8% Arginine toothpaste

Experimental group

Description:

For the study period (12 weeks), subjects in the Investigative Arm will be instructed to brush their teeth with an 8% Arginine toothpaste.

Treatment:

Device: 8% Arginine toothpaste

Control Arm- a 1000 ppm F toothpaste

Active Comparator group

Description:

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.

Treatment:

Drug: 1000 ppm F toothpaste