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The objective of this study is to determine the metagenomic and metatranscriptomic analysis of clinical 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer | Experimental | Toothpaste |
|
| Colgate Cavity Protection | Other | Toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer | Drug | Toothpaste |
|
| Measure | Description | Time Frame |
|---|---|---|
| DNA (metagenomic) sequences | The primary outcome is to collect plaque following each treatment and to assess DNA | 38 weeks |
| RNA (metatranscriptomic) sequences | The primary outcome is to collect plaque following each treatment and to assess RNA | 38 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Luciana Rinaudi-Marron, DR | Colgate Palmolive | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College London Dental Institute, UK | London | United Kingdom |
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| ID | Term |
|---|---|
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Each subject will be randomized.
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| Colgate Cavity Protection | Drug | Toothpaste |
|