Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine

Phase 3

Recruiting

• Conditions: Xerostomia
• Interventions: Device: 8% Arginine toothpaste; Drug: 1000 ppm F toothpaste

• Registration Number: NCT06365047
• Lead Sponsor: Tufts University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-10
• Study First Posted: 2024-04-15
• Study Start: 2024-08-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigative Arm- Using an 8% Arginine toothpaste	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.
Control Arm- a 1000 ppm F toothpaste	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.

Primary Outcome Measures

Name	Time	Method
Salivary pH Impact	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Measuring the change in the oral microbiome	12 weeks	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.

Trial Locations

Locations (1)

Tufts University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States