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Completed

NCT Number: NCT06353165

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

M U International Oral Science Research, Ltd.

Bangkok, 10250, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

stannous fluoride toothpaste

Drug

product containing 0.45% stannous fluoride

Other names: experimental

Colgate Dental Cream

Drug

product containing 0.76% sodium monofluorophosphate

Other names: control

Primary outcomes

  1. Whole mouth scores of dental plaque

    Time frame: baseline, 2 week & 4 week

    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.

  2. Measurement of total bacterial counts on tongue

    Time frame: baseline, 2 week & 4 week

    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

  3. Measurement of total bacterial counts on cheek

    Time frame: baseline, 2 week & 4 week

    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

  4. Measurement of gingivitis

    Time frame: baseline, 2 week & 4 week

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

  5. Measurement of total bacterial counts in saliva

    Time frame: baseline, 2 week & 4 week

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

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2024
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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