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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Organoleptic Oral Malodor Evaluations
Timeframe: Oral malodor evaluations at baseline & 3 weeks