CompletedPhase 2

A Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children

United States, Puerto Rico2,025 participantsStarted 2021-01-21

Plain-language summary

The objective of this study is to assess the safety and to evaluate the anti-caries efficacy of COL101 (arginine) non-fluoride dentifrices compared to a 0.24% sodium fluoride dentifrice in 10-14 year-old children over a one year period.

Who can participate

Age range

10 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject assent and parental/guardian informed consent for voluntary participation.
. Willingness and ability to use the assigned products according to instructions, availability for all appointments and likelihood of completing the clinical trial.
. 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.
. Good general health as evidenced by a review of the medical history.
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incremental Subject-wise Decayed Missing or Filled Surfaces (DMFS) Score Between the Baseline and the Month 12 Visits

Timeframe: Between the Baseline and the Month 12 visits

Trial details

NCT IDNCT04750902

SponsorColgate Palmolive

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-28

Results submitted2026-03-17

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