A Phase 2 Randomized, Double-blind, Active-controlled Multi-center Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices With 1.5%, 4.0% and 8.0% Arginine Each in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children

CRO-2020-CAR-ARG-ED

The objective of this study is to assess the safety and to evaluate the anti-caries efficacy of COL101 (arginine) non-fluoride dentifrices compared to a 0.24% sodium fluoride dentifrice in 10-14 year-old children over a one year period.

2021-01-21

2024-03-01

2024-03-01

Active (not recruiting)

Early phase I

2000

Inclusion Criteria: * Subjects meeting all criteria below will be included in the study: 1. Subject assent and parental/guardian informed consent for voluntary participation. 2. Willingness and ability to use the assigned products according to instructions, availability for all appointments and likelihood of completing the clinical trial. 3. Children ages 10-14 years at baseline. 4. Presence of permanent second molars or evidence of at least one permanent second molar erupting as indicated by cuspal break through the mucosa. 5. Good general health as evidenced by a review of the medical history. 6. Subjects who, at study entry, have present two or more active caries lesions (ICDAS scores of 2 or greater) in permanent teeth and previous caries experience (DMFT \>1), D= Decayed is defined as ICDAS scores of 3 or greater 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2000, 'type': 'ACTUAL'}}

2024-03-01