Colgate Arginine Study
Note: study has closed enrollment
A Phase 2 randomized, double-blind, active-controlled multi-center clinical trial to assess the safety and the anti-caries efficacy of COL 101 (arginine) non-fluoride dentifrices with 1.5%, 4.0% and 8.0% arginine each in comparison with 0.24% sodium fluoride (1100 ppm F) dentifrice control in 10 to 14-year-old children.
Principal Investigator: David Hershkowitz, DDS, AAS
This Study Sponsored by: Colgate-Palmolive
The purpose of this research study is to test how effective a new toothpaste is in reducing tooth cavities. This new toothpaste contains arginine, an essential amino acid that is naturally found in saliva and produced by the human body. In this study, we will compare regular fluoride toothpastes that you could buy in a store to this new toothpaste which contains arginine.
Your child may be eligible for this study if they are aged 10-14 years, are in good general health, and have a history of dental cavities. Eligible participants will be asked to attend study visits once every 3 months for a year (5 visits in total) to have a dental exam and complete questionnaires. Participants will be given study toothpaste and a toothbrush to use throughout their participation in the study.