Stannous Fluoride Toothpaste for Reduction and Treatment of Gingivitis (NCT07640399) | Clinical Trial Compass
CompletedNot Applicable
Stannous Fluoride Toothpaste for Reduction and Treatment of Gingivitis
Canada133 participantsStarted 2025-03-17
Plain-language summary
This study evaluated the efficacy of a stannous fluoride toothpaste compared to a sodium fluoride control toothpaste in reducing gingivitis, bleeding, and plaque over a 12-week period.
A total of 132 subjects were randomized to one of two treatment groups and assessed at baseline and at Weeks 2, 4, 8, and 12 using standardized clinical indices, including the Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI).
Who can participate
Age range
18 Years – 65 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:
* Male or female subjects aged 18 to 65 years (inclusive)
* Provided written informed consent prior to participation
* Able to brush their own teeth on a daily basis
* In good general health based on medical history review
* Minimum of at least 18 natural, scorable teeth
* Mean plaque index score ≥ 1.95
* Mean baseline gingival index score ≥ 1.70 and ≤ 3.0
* Agreed to refrain from use of all oral hygiene products other than those supplied for the study
* Agreed to refrain from oral hygiene, eating, drinking, and chewing gum for approximately 12 hours prior to study visits
* Agreed not to undergo dental prophylaxis or elective dental procedures during the study
* Willing and able to comply with study procedures and visit schedule
Exclusion Criteria:
* Physical limitations or restrictions that preclude normal tooth brushing
* Requirement for premedication prior to dental treatment
* Pregnancy or intent to become pregnant during the study period
* Use of tobacco or nicotine products
* Poor oral hygiene defined as \>40 bleeding sites
* Presence of dental caries or calculus deposits that may interfere with plaque assessments
* Major oral hard or soft tissue lesions or trauma at baseline
* Presence of fixed or removable orthodontic appliances
* Dental prophylaxis within 1 month prior to baseline visit
* History of significant adverse events, allergy, or irritation related to oral hygiene products
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
Evaluate the efficacy of a stannous fluoride toothpaste in gingival inflammation