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

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

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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