Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples

This study is a blinded, non-randomized, crossover design. Subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following enrollment, subjects will be asked to use a washout dentifrice (#200000035883/001/000) for a minimum of 1 week. Fasting plaque will be collected at Baseline and then again at a duplicate baseline collection up to 1 week after the baseline collection. Subjects will be assigned a new dentifrice (#200000035883/001/000) to use for 12 weeks. After 12 weeks' use, fasting plaque will be collected. There will be a duplicate plaque collection up to 1 week after 12 week collection. Subjects will be given a new dentifrice (#200000040228/001/000) to use for the next 24 weeks. After 24 weeks' use, fasting plaque will be collected, and there will be a duplicate plaque collection up to 1 week after this collection.

Inclusion criteria

• Male and/or female subjects 16 years and above
• Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
• Caries active subjects will have at least 3 active caries lesions (ICDAS score 1 - 3). Caries free control subjects will either have ICDAS score 0 or ICDAS score of 1 - 3 where the lesion is inactive.
• Available throughout entire study
• Willing to use only assigned products for oral hygiene throughout the duration of the study
• Must give written informed consent
• Must be in good general health

Exclusion criteria

• Unwilling or unable to sign an Informed Consent Form
• Advanced periodontal disease
• Medical condition which requires premedication prior to dental visits/procedures
• Diseases of the soft or hard oral tissues
• Orthodontic appliances that interfere with clinical assessments
• Impaired salivary function
• Current use of drugs that can affect salivary flow
• Use antibiotics 3 months prior to or during this study
• Use of any arginine containing oral care products such as Colgate Sensitive Pro-Relief and Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer dentifrices 3 months prior to or during this study
• Pregnant or breastfeeding
• Participate in another clinical study 1 week prior to the start of the washout period or during the study period
• Use of tobacco products
• Allergic to common dentifrice ingredients
• Allergic to amino acids
• Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy)