Plaque Clinical Trial
Official title:
Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples
Verified date | November 2021 |
Source | Colgate Palmolive |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to determine the metagenomic and metatranscriptomic analysis of clinical samples.
Status | Completed |
Enrollment | 34 |
Est. completion date | October 17, 2018 |
Est. primary completion date | October 17, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College London Dental Institute, UK | London |
Lead Sponsor | Collaborator |
---|---|
Colgate Palmolive |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | DNA (metagenomic) sequences | The primary outcome is to collect plaque following each treatment and to assess DNA | 38 weeks | |
Primary | RNA (metatranscriptomic) sequences | The primary outcome is to collect plaque following each treatment and to assess RNA | 38 weeks |
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