Anti-bacterial Clinical Study on Teeth, Tongue, Cheek, Gum, and Saliva

NCT06353165 | Completed Phase 3

• 1 other identifier: CRO-2022-12-BAC-SNF-THA-YPZ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This 4-week clinical study was designed to examine the antibacterial efficacy of brushing with a 0.454% stannous fluoride toothpaste with potassium nitrate and pyrophosphate compared to a toothpaste containing 0.76% MFP (marketed as Colgate Cavity Protection Toothpaste) in different regions of the mouth (dental plaque, tongue, cheek, gum surface and in saliva) 12 hours post-brushing (overnight) after 2 and 4 weeks of product use.

Conditions

Plaque, Dental

Keywords

bacteria; plaque; saliva

Outcome Measures

Primary Outcomes (5)

• Whole mouth scores of dental plaque

  Measuring the dental plaque using the Turesky Modification of Quigley-Hein.Subjects presenting with whole mouth scores for dental plaque of 1.5 or more \[Turesky Modification of plaque will be enrolled. Quigley-Hein.

  baseline, 2 week & 4 week

• Measurement of total bacterial counts on tongue

  Scrapings from the surface of the tongue. All collected samples will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis

  baseline, 2 week & 4 week

• Measurement of total bacterial counts on cheek

  Scrapings from the surface of the cheek mucosa. All collected samples will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis

  baseline, 2 week & 4 week

• Measurement of gingivitis

  Using the Loe-Silness index.Subjects presening will 1.0 or more for gingivitis \[Loe-Silness\] will be enrolled.

  baseline, 2 week & 4 week

• Measurement of total bacterial counts in saliva

  Collected samples in saliva will be placed in sterile vials, labeled with subject information and transferred to the laboratory for analysis

  baseline, 2 week & 4 week

Study Arms (2)

Group I

ACTIVE COMPARATOR

toothpaste brushing 2/day for 2 minutes

Drug: Colgate Dental Cream

Group II

EXPERIMENTAL

toothpaste brushing 2/day for 2 minutes

Drug: Stannous fluoride toothpaste

Interventions

Stannous fluoride toothpaste DRUG

product containing 0.45% stannous fluoride

Also known as: experimental

Group II

Colgate Dental Cream DRUG

product containing 0.76% sodium monofluorophosphate

Also known as: control

Group I

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects, ages 18-70, inclusive.
• Subject is available during study duration and has no allergies to oral hygiene formulations.
• A minimum of 20 natural teeth with facial and lingual scorable surfaces.
• A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and clinical examination schedules.
• Subjects with a baseline whole mouth scores of dental plaque of 1.5 or more \[Turesky Modification of Quigley-Hein\] and gingivitis index of 1.0 or more \[Loe-Silness\].

You may not qualify if:

• Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study.
• History of dental prophylaxis or treatments in the past month or during study duration.
• History of medical treatments including antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding study enrollment.
• Subjects scheduled for medical procedures for the duration of the study.
• Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.
• History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients.
• History of diabetes or hepatic or renal disease, or medical or inflammatory conditions or transmittable diseases, e.g. heart disease or AIDS.
• History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
• Oral soft tissue pathology.
• History of active or severe periodontal disease and loose teeth.
• Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).
• Fixed or removable orthodontic appliance or removable partial dentures.
• Self-reported pregnancy or lactation.
• Subjects known to be an alcoholic, or a recovering alcoholic.
• History or current use of recreational drugs or other habit promoting products.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

M U International Oral Science Research, Ltd.

Bangkok, Bangkok, 10250, Thailand

Location

MeSH Terms

Conditions

Dental Plaque; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: blinded

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: April 8, 2024
• Study Start: March 8, 2023
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)