A Randomized Single-center, Double-blind, Two-cell Parallel-group Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a New Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Oral Malodor 12 Hours Post-brushing Overnight After 3 Weeks of Twice a Day (Morning and Evening) Product Use.
| Registry | NCT07223073 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 80 (Actual) |
| Sponsor | Colgate Palmolive (Industry) |
| Conditions | Oral Malodor |
| Interventions | 0.454% stannous fluoride, 0.76% sodium monofluorophosphate (Drug) |
| Dates | start 2017-12-21, primary completion 2018-01-12, completion 2018-01-12, first posted 2025-10-31, last updated 2025-10-31 |
| Locations | 1 site in Thailand |
Related Papers Related Patents Related Grants Related Experts
All trials for Oral Malodor All trials of 0.454% stannous fluoride All trials of 0.76% sodium monofluorophosphate
To investigate the clinical efficacy of a new toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate on oral malodor reduction via organoleptic scores 12 hours post-brushing overnight after 3 weeks of twice a day (morning and evening) product use.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Test 1 toothpaste | Experimental | Drug: 0.454% stannous fluoride | |
| Test 2 Toothpaste | Active comparator | Drug: 0.76% sodium monofluorophosphate |
Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers
Inclusion Criteria: * Male and female adults between the ages of 18-70 (inclusive) * Subjects must be in general good health * Subjects must be in good oral health based on self-assessment * Subjects must be available for the duration of the study for all time point assessments * Subjects were required to possess a minimum of 20 natural uncrowned teeth (excluding third molars) * Subjects were required to sign an Informed Consent form * No known history or allergies to personal care/consumer products or their ingredients. Exclusion Criteria: * Participated in any other oral clinical studies during the duration of this study * Had full or partial (upper or lower) dentures * Women who are pregnant or lactating (breast feeding) * Use of tobacco products, (5) History of allergies to common mouthwash ingredients * Use of phenolic flavored products, such as mint flavored candies and chewing gum the morning of the study of during the sampling periods * Immune compromised individuals (HIV, AIDS, immune suppressive drug therapy * Individuals who, due to medical conditions cannot go without eating or drinking for the post use treatment evaluation time points (6-hours plus overnight).
| Facility | City | Country | Status |
|---|---|---|---|
| M U International Oral Science Research, Ltd. | Bangkok, Bangkok | Thailand |