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Non-fluoride vs Fluoride Toothpaste for Tooth Decay

Phase 2
Waitlist Available
Research Sponsored by Colgate Palmolive
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children ages 10-14 years at baseline
Presence of permanent second molars or evidence of at least one permanent second molar erupting as indicated by cuspal break through the mucosa
Must not have
Presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth
Long-term antibiotic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Summary

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

Who is the study for?
This trial is for children aged 10-14 with good general health, who have at least two active caries lesions but not severe caries on five or more teeth. They must be able to follow the study's product use instructions and commit to all appointments. Kids with severe periodontal disease, recent participation in another clinical study, pregnancy, orthodontic treatments on multiple teeth, cognitive/motor impairments, or allergies to arginine/oral care products are excluded.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of COL101 (arginine) non-fluoride toothpaste in preventing cavities compared to a standard fluoride toothpaste over one year. Children will receive either an 8%, 4%, or 1.5% arginine dentifrice or a control toothpaste containing 0.24% sodium fluoride.See study design
What are the potential side effects?
Potential side effects may include allergic reactions specific to arginine or other ingredients in the tested products since these are oral care items designed for regular use; however, significant side effects are not commonly expected from such products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 10 and 14 years old.
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My second permanent molars have started to come in.
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I have two or more active tooth cavities and a history of tooth decay.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a dental device or braces on more than four of my teeth.
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I am on long-term antibiotics.
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My child has a confirmed diagnosis of cognitive or motor impairment.
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I have a severe misalignment of my teeth.
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I have severe tooth decay in five or more of my permanent teeth.
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I have moderate to severe gum disease.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces (DMFS) score after one year of product use
Secondary outcome measures
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.
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.
Clinically significant changes indicating caries regression are changes in ICDAS severity values from 2 or higher to 0 or 1.
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: 8.0% Arginine DentifriceExperimental Treatment1 Intervention
Toothpaste
Group II: 4.0% Arginine DentifriceExperimental Treatment1 Intervention
Toothpaste
Group III: 1.5% Arginine DentifriceExperimental Treatment1 Intervention
Toothpaste
Group IV: 0.24% Sodium Fluoride DentifriceActive Control1 Intervention
Toothpaste
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arginine
Not yet FDA approved
Arginine
Not yet FDA approved
Arginine
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Colgate PalmoliveLead Sponsor
91 Previous Clinical Trials
15,864 Total Patients Enrolled
Maria E Ryan, DDS PhDStudy DirectorColgate-Palmolive Company

Media Library

1.5% Arginine Dentifrice (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04750902 — Phase 2
Tooth Decay Research Study Groups: 0.24% Sodium Fluoride Dentifrice, 1.5% Arginine Dentifrice, 4.0% Arginine Dentifrice, 8.0% Arginine Dentifrice
Tooth Decay Clinical Trial 2023: 1.5% Arginine Dentifrice Highlights & Side Effects. Trial Name: NCT04750902 — Phase 2
1.5% Arginine Dentifrice (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04750902 — Phase 2
~444 spots leftby Jul 2025
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