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
NCT ID: NCT04750902
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
2000 participants
INTERVENTIONAL
2021-01-21
2024-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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0.24% Sodium Fluoride Dentifrice
Toothpaste
0.24% Sodium Fluoride Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
1.5% Arginine Dentifrice
Toothpaste
1.5% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
4.0% Arginine Dentifrice
Toothpaste
4.0% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
8.0% Arginine Dentifrice
Toothpaste
8.0% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Interventions
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0.24% Sodium Fluoride Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
1.5% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
4.0% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
8.0% Arginine Dentifrice
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Eligibility Criteria
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Inclusion Criteria
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
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.
10 Years
14 Years
ALL
Yes
Sponsors
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Colgate Palmolive
INDUSTRY
Responsible Party
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Principal Investigators
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Maria E Ryan, DDS PhD
Role: STUDY_DIRECTOR
Colgate-Palmolive Company
Locations
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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
Countries
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Other Identifiers
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CRO-2020-CAR-ARG-ED
Identifier Type: -
Identifier Source: org_study_id
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