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

Clinical Investigation Examining the Anticaries Efficacy of 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): a Two-year Caries Clinical Study

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

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.