Assessment of 1450 Ppm Fluoride/Arginine Toothpaste Using an Intra-oral Remineralization-demineralization Model.

ERO-2014-CAI-02-RPS

This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.

2015-04-01

2015-07-01

2015-07-01

Withdrawn

Early phase I

Inclusion Criteria: 1. Male and/or female subjects 18 to 50 years inclusive 2. Minimum of 20 natural uncrowned teeth (excluding third molars) must be present 3. Willing to wear retainer 24 hours per day 4. No active, unrestored cavities 5. Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥ 0.2 ml/min respectively) ascertained from a preliminary sialometry 6. Available throughout entire study 7. Willing to use only assigned products for oral hygiene throughout the duration of the study 8. Must give written informed consent 9. Must be in good general health 10. No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study Exclusion Criteria: 1. Advanced periodontal disease 2. Medical condition which requires premedication prior to dental visits/procedures 3. Not enough teeth to secure the oral retainer 4. Diseases of the soft or hard oral tissues 5. Wear an Orthodontic appliances 6. Impaired salivary function 7. Current use drugs that can affect salivary flow 8. Use antibiotics one (1) month prior to or during this study 9. Pregnant or breastfeeding 10. Participate in another clinical study one (1) week prior to the start of the washout period or during this 9-week study period 11. Use tobacco products 12. Allergic to common toothpaste ingredients 13. Allergic to amino acids 14. Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy)

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2022-09-27