1.5% Arginine Dentifrice for Tooth Decay

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Tooth Decay1.5% Arginine Dentifrice - Drug
Eligibility
10 - 14
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the safety and effectiveness of a non-fluoride toothpaste to a fluoride toothpaste in children aged 10-14.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: one year

12 months
Clinically significant changes indicating caries regression are changes in ICDAS severity values from 2 or higher to 0 or 1.
6 months
Clinically significant changes indicating caries progression are changes in ICDAS severity values from 0 to 2 or higher, from 1 or 2 to 3 or higher, or from 3 or 4 to 5 or 6.
after 6 months
Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score after 6-months of product use;
between 6-months and one year
Clinically significant change in International Caries Detection and Assessment System (ICDAS) severity scores between the baseline and the six-month and one-year examinations and between the six-month and one-year examinations.
Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score between 6- months and one year of product use.
one year
The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces (DMFS) score after one year of product use

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

0.24% Sodium Fluoride Dentifrice
1 of 4
1.5% Arginine Dentifrice
1 of 4
4.0% Arginine Dentifrice
1 of 4
8.0% Arginine Dentifrice
1 of 4

Active Control

Experimental Treatment

2000 Total Participants · 4 Treatment Groups

Primary Treatment: 1.5% Arginine Dentifrice · No Placebo Group · Phase 2

1.5% Arginine Dentifrice
Drug
Experimental Group · 1 Intervention: 1.5% Arginine Dentifrice · Intervention Types: Drug
4.0% Arginine Dentifrice
Drug
Experimental Group · 1 Intervention: 4.0% Arginine Dentifrice · Intervention Types: Drug
8.0% Arginine Dentifrice
Drug
Experimental Group · 1 Intervention: 8.0% Arginine Dentifrice · Intervention Types: Drug
0.24% Sodium Fluoride Dentifrice
Drug
ActiveComparator Group · 1 Intervention: 0.24% Sodium Fluoride Dentifrice · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arginine
Not yet FDA approved
Arginine
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: one year

Who is running the clinical trial?

Colgate PalmoliveLead Sponsor
73 Previous Clinical Trials
13,668 Total Patients Enrolled
Maria E Ryan, DDS PhDStudy DirectorColgate-Palmolive Company

Eligibility Criteria

Age 10 - 14 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient has generally good health and no major medical problems are noted from their medical history.
, M= Missed is defined as ICDAS scores of 1 or 2, F=Filled is defined as ICDAS scores of 0 People who have two or more active caries lesions, previous caries experience, and scores of 3 or greater on the ICDAS scale are considered to have decayed teeth.
I give my consent for my child to participate in this study voluntarily
The subject's willingness and ability to use the assigned products according to instructions, availability for all appointments, and likelihood of completing the clinical trial.
Children aged 10-14 at the start of the study.
Presence of a permanent second molar tooth.

Who else is applying?

What state do they live in?
New York100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%