Clinical trial NCT05138978: Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples
Official title: Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2021-12-01
Enrollment: 34
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each subject will be randomized.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: DNA (metagenomic) sequences
timeFrame: 38 weeks
measure: RNA (metatranscriptomic) sequences
timeFrame: 38 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London Dental Institute, UK
Study officials:
affiliation: Colgate Palmolive
name: Luciana Rinaudi-Marron, DR
role: STUDY_DIRECTOR
References: