Plaque
Conditions
Brief summary
The objective of this study is to determine the metagenomic and metatranscriptomic analysis of clinical samples.
Detailed description
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.
Interventions
DRUGColgate Maximum Cavity Protection plus Sugar Acid Neutralizer
Toothpaste
Toothpaste
Sponsors
Colgate Palmolive
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Each subject will be randomized.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DNA (metagenomic) sequences | 38 weeks | The primary outcome is to collect plaque following each treatment and to assess DNA |
| RNA (metatranscriptomic) sequences | 38 weeks | The primary outcome is to collect plaque following each treatment and to assess RNA |
Countries
United Kingdom
Outcome results
None listed