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

Plaque, Dental Clinical Trial

Official title:

A Clinical Study to Investigate Stannous Fluoride Toothpaste on Antibacterial Effects in the Different Regions of the Mouth as Compared to Colgate Cavity Protection Toothpaste

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06353165
• Other study ID #: CRO-2022-12-BAC-SNF-THA-YPZ
• Status: Completed
• Phase: Phase 3
• Start date: March 8, 2023
• Est. completion date: April 12, 2023

Study information

• Verified date: April 2024
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 12, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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].

Exclusion Criteria:

• 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.
• Use of phenolic flavored products, such as mint flavored candies and chewing gum, during the study period.
• Ability to refrain from oral hygiene for twelve (12) hours prior to scheduled visit.

Related Conditions & MeSH terms

• Dental Plaque
• Plaque, Dental

Intervention

Drug:
• Stannous fluoride toothpaste
product containing 0.45% stannous fluoride
• Colgate Dental Cream
product containing 0.76% sodium monofluorophosphate

Locations

Country	Name	City	State
Thailand	M U International Oral Science Research, Ltd.	Bangkok	Krung Thep Maha Nakhon

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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