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Study to Investigate Toothpaste on Antibacterial Effects in the Different Regions of the Mouth

NCT07458464 — Phase 3, Completed, 95 participants, Colgate Palmolive

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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.

RegistryNCT07458464
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment95 (Actual)
SponsorColgate Palmolive (Industry)
ConditionsPlaque, Gingivitis
Interventionsstannous fluoride toothpaste, 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste (Drug)
Datesstart 2026-05-18, primary completion 2026-06-28, completion 2026-06-28, first posted 2026-03-09, last updated 2026-09-24
Locations2 sites in Thailand

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-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
Test 1 ToothpasteExperimentalDrug: stannous fluoride toothpasteInstructed to brush will full ribbon, 2x day/2 min with toothpaste
Test 2 toothpasteActive comparatorDrug: 0.76% Sodium Monofluorophosphate (Na MFP) toothpasteInstructed to brush will full ribbon, 2x day/2 min with toothpaste
  • stannous fluoride toothpaste (Drug): toothpaste
  • 0.76% Sodium Monofluorophosphate (Na MFP) toothpaste (Drug): toothpaste

+Outcome measures

Primary outcomes

  • Loe-Silness [baseline, 2 week and 4 week]: gingivitis index of 1.0 or more
  • Turesky Modification of Quigley-Hein [baseline, 2 week and 4 week]: whole mouth scores of dental plaque of 1.5 or more

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

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.

+Locations (2)

FacilityCityCountryStatus
Mahidol UniversityRatchathewi, BangkokThailand
Mahidol UniversityBangkok, Bangkok 10110Thailand

My Notes