Could an amino acid replace fluoride in toothpaste? new trial tests arginine against cavities

NCT ID NCT04750902

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study tests whether toothpaste containing arginine, an amino acid, can prevent cavities in children aged 10 to 14. Participants brush twice daily with one of three strengths of arginine toothpaste or a standard fluoride toothpaste for one year. Researchers measure new cavities, fillings, or missing teeth to see if arginine works as well as fluoride.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
arginine toothpaste (COL 101) at 1.5%, 4.0%, or 8.0% arginine
What this could lead to
If effective, arginine toothpaste could offer a fluoride-free option for cavity prevention in children.
What could go wrong
This is a phase 2 trial, so results are preliminary. Arginine may not work as well as fluoride, and higher doses could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

2,025 people

The number who actually took part.

Started

Jan 2021

Finished

Feb 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 14 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects meeting all criteria below will be included in the study: 1. Subject assent and parental/guardian informed consent for voluntary participation. 2. Willingness and ability to use the assigned products according to instructions, availability for all appointments and likelihood of completing the clinical trial. 3. Children ages 10-14 years at baseline. 4. Presence of permanent second molars or evidence of at least one permanent second molar erupting as indicated by cuspal break through the mucosa. 5. Good general health as evidenced by a review of the medical history. 6. Subjects who, at study entry, have present two or more active caries lesions (ICDAS scores of 2 or greater) in permanent teeth and previous caries experience (DMFT \>1), D= Decayed is defined as ICDAS scores of 3 or greater Exclusion Criteria: * Subjects presenting any of the criteria below will be excluded from the study: 1. Presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth. 2. Use of medication that could increase the risk of developing dental caries, i.e. medications that reduce saliva flow and those with high sugar content. 3. Long-term antibiotic therapy. 4. Children with a confirmed diagnosis of cognitive and/or motor impairment. 5. Severe malocclusion. 6. Subjects who, at study entry, have present severe caries (ICDAS 5 or 6) on five or more permanent teeth. 7. Evidence of moderate to severe periodontal disease. 8. Participation in any other clinical study within the 30 days preceding the start of the clinical study. 9. Known history of allergies or other adverse reactions to arginine, or oral care products, or their ingredients. 10. Self-reported history of being currently pregnant, intending to become pregnant during the trial period or breast-feeding.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Indiana University School of Dentistry

    Indianapolis, Indiana, 46202-2876, United States

  • Loma Linda University School of Dentistry

    Loma Linda, California, 92350, United States

  • The Forsyth Institute

    Boston, Massachusetts, 02142, United States

  • Tufts University School of Dental Medicine

    Boston, Massachusetts, 02111, United States

  • UT Health San Antonio School of Dentistry

    San Antonio, Texas, 78229-3900, United States

  • University at Buffalo School of Dental Medicine

    Buffalo, New York, 14214, United States

  • University of Florida College of Dentistry

    Gainesville, Florida, 32610, United States

  • University of Pennsylvania School of Dental Medicine

    Philadelphia, Pennsylvania, 19104-6003, United States

  • University of Puerto Rico School of Dental Medicine

    San Juan, Puerto Rico

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