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

• Status: Completed
• Trial end date: 2022-03-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Colgate Palmolive
• Treatments: Fluorides; Listerine; Sodium Fluoride

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.