Clinical trial NCT06353165: Anti-bacterial Clinical Study on Teeth, Tongue, Cheek, Gum, and Saliva
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque, Dental
Keywords: bacteria
plaque
saliva
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2024-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: blinded
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Whole mouth scores of dental plaque
timeFrame: baseline, 2 week & 4 week
measure: Measurement of total bacterial counts on tongue
timeFrame: baseline, 2 week & 4 week
measure: Measurement of total bacterial counts on cheek
timeFrame: baseline, 2 week & 4 week
measure: Measurement of gingivitis
timeFrame: baseline, 2 week & 4 week
measure: Measurement of total bacterial counts in saliva
timeFrame: baseline, 2 week & 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: M U International Oral Science Research, Ltd.
state: Krung Thep Maha Nakhon
Study officials:
References: