Could an amino acid replace fluoride in toothpaste? new trial tests arginine against cavities
NCT ID NCT04750902
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
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Feb 2024
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Indiana University School of Dentistry
Indianapolis, Indiana, 46202-2876, United States
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Loma Linda University School of Dentistry
Loma Linda, California, 92350, United States
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The Forsyth Institute
Boston, Massachusetts, 02142, United States
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Tufts University School of Dental Medicine
Boston, Massachusetts, 02111, United States
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UT Health San Antonio School of Dentistry
San Antonio, Texas, 78229-3900, United States
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University at Buffalo School of Dental Medicine
Buffalo, New York, 14214, United States
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University of Florida College of Dentistry
Gainesville, Florida, 32610, United States
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University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, 19104-6003, United States
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University of Puerto Rico School of Dental Medicine
San Juan, Puerto Rico
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Other studies related to the condition(s) this trial covers.
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