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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,000
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
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
The primary efficacy endpoint will be the incremental subject-wise Decayed Missing Filled Surfaces (DMFS) score after one year of product use
the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome
Time frame: one year
Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score after 6-months of product use;
the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome
Time frame: after 6 months
Incremental subject-wise Decayed Missing Filled Surfaces (DFMS) score between 6- months and one year of product use.
the minimum score is 0, maximum score is 4/5 depending on the tooth number and a higher score represents a worse outcome
Time frame: between 6-months and one year
Clinically significant change in International Caries Detection and Assessment System (ICDAS) severity scores between the baseline and the six-month and one-year examinations and between the six-month and one-year examinations.
the minimum score is 0, maximum score is 6 and a higher score represents a worse outcome
Time frame: between 6-months and one year
Clinically significant changes indicating caries progression are changes in ICDAS severity values from 0 to 2 or higher, from 1 or 2 to 3 or higher, or from 3 or 4 to 5 or 6.
Time frame: 6 months
Clinically significant changes indicating caries regression are changes in ICDAS severity values from 2 or higher to 0 or 1.
Time frame: 12 months
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Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
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