Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples

NCT05138978 | Completed Phase 2

• 1 other identifier: ERO-2015-PLA-07-RPS
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the metagenomic and metatranscriptomic analysis of clinical samples.

Conditions

Plaque

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer

EXPERIMENTAL

Toothpaste

Drug: Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer

Colgate Cavity Protection

OTHER

Toothpaste

Drug: Colgate Cavity Protection

Interventions

Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer DRUG

Toothpaste

Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer

Colgate Cavity Protection DRUG

Toothpaste

Colgate Cavity Protection

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

King's College London Dental Institute, UK

London, United Kingdom

Location

MeSH Terms

Conditions

Plaque, Amyloid

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Luciana Rinaudi-Marron, DR

  Colgate Palmolive

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject will be randomized.

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 1, 2021
• Study Start: October 6, 2017
• Primary Completion: October 17, 2018
• Study Completion: October 17, 2018
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

GB (1)