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Anti-cavity Toothpaste

Arginine Toothpaste for Dry Mouth

Phase 3
Recruiting
Led By Athena Papas, DMD, PhD
Research Sponsored by Tufts University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will look at how using a toothpaste with arginine for 3 months affects the mouth. The study will involve 70 male and female participants who will be randomly assigned to use either the

Who is the study for?
This trial is for men and women with dry mouth who meet specific health requirements. Participants will be using one of two toothpastes over three months to see if there's an improvement in their oral condition.
What is being tested?
The study compares Colgate Cavity Protection Fluoride Toothpaste with Tom's of Maine Rapid Relief toothpaste, both containing arginine, to see which is better for dry mouth over a period of three months.
What are the potential side effects?
Since the trial involves toothpaste use, potential side effects may include irritation in the mouth, allergic reactions or increased sensitivity. However, these are generally rare.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Salivary pH Impact
Secondary study objectives
Measuring the change in the oral microbiome

Side effects data

From 2012 Phase 3 trial • 72 Patients • NCT01641237
2%
Mouth Ulceration
2%
Cough
2%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
NaF Dentifrice (1426 ppmF)
Placebo Dentifrice (0 ppmF)
NaF Dentifrice (250 ppmF)
NaF Dentifrice (1150 ppmF)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Investigative Arm- Using an 8% Arginine toothpasteExperimental Treatment1 Intervention
For the study period (12 weeks), subjects in the Investigative Arm will be instructed to brush their teeth with an 8% Arginine toothpaste.
Group II: Control Arm- a 1000 ppm F toothpasteActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Colgate PalmoliveIndustry Sponsor
101 Previous Clinical Trials
18,739 Total Patients Enrolled
Tufts UniversityLead Sponsor
270 Previous Clinical Trials
596,513 Total Patients Enrolled
2 Trials studying Xerostomia
125 Patients Enrolled for Xerostomia
Athena Papas, DMD, PhDPrincipal InvestigatorTufts University School of Dental Medicine
2 Previous Clinical Trials
474 Total Patients Enrolled
~47 spots leftby Jun 2025
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