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

Completed · Phase 2

Conditions studied: Dental Caries

In brief

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.

Key facts

Study ID

NCT04750902

Run by

Colgate Palmolive

People needed

2025

Starts

2021-01-21

Expected to finish

2024-02-28

Last updated by the study team

2026-07-21

Who can join

Age: 10 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects meeting all criteria below will be included in the study:
• 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

You may not qualify if…

• Subjects presenting any of the criteria below will be excluded from the study:
• Presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth.
• 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.
• Long-term antibiotic therapy.
• Children with a confirmed diagnosis of cognitive and/or motor impairment.
• Severe malocclusion.
• Subjects who, at study entry, have present severe caries (ICDAS 5 or 6) on five or more permanent teeth.
• Evidence of moderate to severe periodontal disease.
• Participation in any other clinical study within the 30 days preceding the start of the clinical study.
• Known history of allergies or other adverse reactions to arginine, or oral care products, or their ingredients.
• Self-reported history of being currently pregnant, intending to become pregnant during the trial period or breast-feeding.

Where it is running

• Loma Linda University School of Dentistry — Loma Linda, California, United States
• University of Florida College of Dentistry — Gainesville, Florida, United States
• Indiana University School of Dentistry — Indianapolis, Indiana, United States
• Tufts University School of Dental Medicine — Boston, Massachusetts, United States
• The Forsyth Institute — Boston, Massachusetts, United States
• University at Buffalo School of Dental Medicine — Buffalo, New York, United States
• University of Pennsylvania School of Dental Medicine — Philadelphia, Pennsylvania, United States
• UT Health San Antonio School of Dentistry — San Antonio, Texas, United States
• University of Puerto Rico School of Dental Medicine — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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