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Not yet recruiting NCT07458464

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

Phase III Interventional Plaque Gingivitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: stannous fluoride toothpaste, 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste.
Who it may be relevant to
Registry conditions: Plaque, Gingivitis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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

Interventions

  • Drug stannous fluoride toothpaste
    toothpaste
  • Drug 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste
    toothpaste

Primary outcome measures

  • Loe-Silness [Time frame: baseline, 2 week and 4 week]
  • Turesky Modification of Quigley-Hein [Time frame: baseline, 2 week and 4 week]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07458464 · CRO-2026-05-BAC-SNI-THA-YPZ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗