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NCT Number: NCT07458464

A Study to Investigate Stannous Fluoride Containing Toothpaste on Antibacterial Effects in the Different Regions of the Mouth

The clinical study will examine the effects of brushing with randomly assigned test toothpaste on the bacteria on the dental plaque, tongue, cheek, gum surface, and in saliva

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Key information

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 mouth rinses. 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.

Treatment and study plan

stannous fluoride toothpaste

Drug

toothpaste

0.76% Sodium Monofluorophosphate (Na MFP) toothpaste

Drug

toothpaste

Primary outcomes

  1. Loe-Silness

    Time frame: baseline, 2 week and 4 week

    gingivitis index of 1.0 or more

  2. Turesky Modification of Quigley-Hein

    Time frame: baseline, 2 week and 4 week

    whole mouth scores of dental plaque of 1.5 or more

Study contacts

Contact information is provided by the study sponsor or research team.

Phraekhun Kanjanakuha

CONTACT

[email protected]

Terdphong Triratana, DDS

CONTACT

[email protected]

66-81-622-2124

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Jul 28, 2026

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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