NCT06365047

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	8% Arginine toothpaste	Investigative
DRUG	1000 ppm F toothpaste	Control

Timeline

• Start date: 2024-08-31
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2024-04-15
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study