Clinical Study on Malodor (NCT06300905) | Clinical Trial Compass
CompletedPhase 3
Clinical Study on Malodor
China100 participantsStarted 2023-06-01
Plain-language summary
This 3-week clinical study was designed to investigate the clinical efficacy on oral malodor of a 0.454% stannous fluoride toothpaste with nitrate and pyrophosphate (referred to as SNAP) compared to Colgate Cavity Protection Toothpaste containing 0.76% sodium monofluorophosphate 12 hours post-brushing after 3 weeks of product use.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Must be male or female 18 to 70 years of age
* Must be in good general health
* Must be in good oral health based on self-assessment
* Must be available during the weeks of this study for all appointment time points
* Should have a minimum of 20 natural uncrowned teeth (excluding third molars)
* Should have a baseline mean oral malodor score greater than or equal to 6.0 and less than or equal to 8.0
* Must give written informed consent
* No known history of allergy to personal care/consumer products or their ingredients
Exclusion Criteria:
* Participation in any other oral clinical studies for the duration of this study
* Full or partial (upper or lower) dentures
* Pregnant or lactating (breast feeding)
* Use of tobacco products
* History of allergy to common toothpaste ingredients
* Use of phenolic flavored products, such as mint flavored candies and chewing gum, the morning of the study and during the sampling periods
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
* Individuals who, due to medical conditions, cannot go without eating or drinking for the post use treatment evaluation time points (6 hrs. + overnight)
What they're measuring
1
Organoleptic Oral Malodor Evaluations
Timeframe: Oral malodor evaluations at baseline & 3 weeks