A Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children

Exclusion Criteria

• •Subjects presenting any of the criteria below will be excluded from the study:
• •1. Presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth.
• •2. Use of medication that could increase the risk of developing dental caries, i.e.
• •medications that reduce saliva flow and those with high sugar content.
• •3. Long-term antibiotic therapy.
• •4. Children with a confirmed diagnosis of cognitive and/or motor impairment.
• •5. Severe malocclusion.
• •6. Subjects who, at study entry, have present severe caries (ICDAS 5 or 6) on five or more permanent teeth.
• •7. Evidence of moderate to severe periodontal disease.
• •8. Participation in any other clinical study within the 30 days preceding the start of the clinical study.
• •9. Known history of allergies or other adverse reactions to arginine, or oral care products, or their ingredients.
• •10. Self-reported history of being currently pregnant, intending to become pregnant during the trial period or breast-feeding.