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Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine

NCT06365047 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-02-10

No results posted yet for this study

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

DEVICE

8% Arginine toothpaste

Investigative

DRUG

1000 ppm F toothpaste

Control

Sponsors & Collaborators

  • Colgate Palmolive

    collaborator INDUSTRY

  • Tufts University

    lead OTHER

Principal Investigators

  • Athena Papas, DMD, PhD · Tufts University School of Dental Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2027-12-01
Completion
2028-06-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06365047 on ClinicalTrials.gov