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2-year Caries Clinical Study: Arginine Fluoride-Free Toothpastes vs. NaF Toothpaste

Colgate-Palmolive logo

Colgate-Palmolive

Status and phase

Completed
Phase 3

Conditions

Dental Caries

Treatments

Drug: 0.32% Sodium Fluoride Dentifrice Toothpaste
Drug: 8.0% Arginine Dentifrice
Drug: 1.5% Arginine Dentifrice

Study type

Interventional

Funder types

Industry

Identifiers

NCT05560945
CRO-2018-12-CAR-ARG-YPZ

Details and patient eligibility

About

The objective of this study is to evaluate the anticaries efficacy for three dentifrices (1.5% arginine in a calcium base, 8.0% arginine in a calcium base, and 0.32% sodium fluoride in a silica base) in a two-year caries clinical study

Enrollment

6,000 patients

Sex

All

Ages

10 to 14 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Informed Consent Form signed by parent or legal guardian to permit participation of their child in the study
  • 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 second molars or evidence of erupting permanent molars.
  • Subjects should be of good general health as evidenced by a review of the medical history.
  • Presence of two or more active caries lesions (ICDAS scores of 2 or greater) and with a previous caries experience (DMFS ≥ 2). Exclusion Characteristics
  • Subjects presenting with 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. medication that reduces saliva flow.
  • Long-term antibiotic therapy.
  • Children with cognitive and/or motor impairment.
  • Severe malocclusion.
  • Presence of severe caries (ICDAS 5 or 6) on five or more teeth.
  • Evidence of moderate to severe periodontal disease.
  • Participation in any other clinical study within the 30 days preceding the clinical study.
  • History of allergies or other adverse reactions to arginine, or oral care products, or their ingredients.
  • Pregnant or lactating.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

6,000 participants in 3 patient groups

0.32% Sodium Fluoride Dentifrice Toothpaste
Active Comparator group
Description:
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Treatment:
Drug: 0.32% Sodium Fluoride Dentifrice Toothpaste
1.5% Arginine Dentifrice Toothpaste
Experimental group
Description:
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Treatment:
Drug: 1.5% Arginine Dentifrice
8.0% Arginine Dentifrice Toothpaste
Experimental group
Description:
Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
Treatment:
Drug: 8.0% Arginine Dentifrice

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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