Evaluation of a Stannous Fluoride Dentifrice for Control of Oral Malodor (NCT07425509) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of a Stannous Fluoride Dentifrice for Control of Oral Malodor
United States49 participantsStarted 2024-09-09
Plain-language summary
This single-center, randomized, double-blind, two-treatment crossover clinical study evaluated the safety and efficacy of a stannous fluoride-containing dentifrice compared with a sodium fluoride control dentifrice for the control of intrinsic oral malodor. Adult subjects brushed twice daily with each product during separate treatment periods following standardized wash-out periods. Oral malodor was assessed using trained organoleptic judges applying a validated Odor Intensity (OI) scale at baseline and multiple post-treatment time points.
Who can participate
Age range
18 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:
* Adults ≥18 years of age in good general health
* Baseline odor intensity score ≥2 after approximately 12 hours of oral hygiene abstention
* Intra-oral source of oral malodor
* At least 18 natural teeth
* Willing to comply with oral hygiene, dietary, and behavioral restrictions
* Able to provide informed consent
Exclusion Criteria:
* Allergy to oral hygiene products
* Pregnant or nursing
* Serious medical conditions affecting oral malodor
* Recent antibiotic or anti-inflammatory medication use
* Smoker or user of smokeless tobacco
* Advanced periodontal disease, frank caries, or significant oral pathology
* Participation in another oral care study within 30 days
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
Change in Odor Intensity Score (OI
Timeframe: Baseline to 12-hour overnight assessment after 7 days of product use