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

Launched by COLGATE PALMOLIVE · Sep 27, 2022

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Gender

ALL

Eligibility 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.