Effect of stannous fluoride toothpaste on gingival health indicators in an experimental gingivitis model
Official title: Exploratory Method Development Randomised, Controlled, Double-Blind, Clinical Study Investigating Gingival Crevicular Fluid Biomarkers Following Use of a Commercially Available Toothpaste Containing Stannous Fluoride
Run by Haleon · NCT07842042 · Data updated 2026-11-12
This study tests whether a toothpaste with stannous fluoride can influence gingival crevicular fluid biomarkers and help gingival tissue recover during early gingivitis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Haleon Industry-sponsored |
| Locations | 1 site (Birmingham) |
| Status | Recruiting |
| Started | September 28, 2026 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07842042 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with induced gingivitis and plaque accumulation, able to comply with study visits and without conditions that would affect gingival health.
✕Probably not a fit
Patients without gingivitis induction or with conditions affecting gingival health may not benefit from biomarker findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this single-center, double-blind, randomized, split-mouth study, healthy volunteers with induced gingivitis will use a test toothpaste containing stannous fluoride on one side of the mouth and a regular fluoride toothpaste on the other side for 14 days. GCF biomarkers will be measured to see if the test toothpaste affects tissue recovery or inflammation differently than the reference toothpaste. Approximately 20 participants will be enrolled to obtain about 18 evaluable participants. The study aims to determine feasibility, sensitivity, and interpretability of GCF biomarkers as early indicators of gingival recovery.
Why it matters
Potential benefit: If successful, the approach could provide earlier or more precise biomarkers of gingival healing in response to toothpaste choices.
How similar studies have gone: Previous work has explored gingival crevicular fluid biomarkers in gingivitis, with some showing promise for noninvasive monitoring, but the specific toothpaste comparison is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * A participant is willing and able to comply with scheduled visits, and other study procedures and restrictions including the lifestyle restrictions. * A participant is in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements. * A participant with probing pocket depths of less than (\<) 3.5mm and a minimum of four teeth from maxillary canine to third molar in both maxillary quadrants that are scorable (including two molars and at least one premolar) at screening. * A participant has, localized, plaque induced gingivitis at screening, defined as \>= 10 and less than equal to (\<=) 30% of sites exhibiting bleeding on probing (BOP). * A participants have a canine, one or two premolars, and two or three molars present in each maxillary quadrant (right and left side). Exclusion Criteria: * A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family. * A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation. * A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study. * A participant who is breast feeding, is pregnant (self-reported) or intending to become pregnant over the duration of the study. * A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. * A participant unwilling or unable to comply with the lifestyle considerations described in this protocol. * A participant with a recent history (within the last year) of alcohol or other substance abuse. * Participant who: 1. Is taking antibiotics during the study or has taken antibiotics in the two weeks prior to the screening visit. 2. Is using or has used an anti-bacterial toothpaste/mouthwash (e.g., chlorhexidine) or another oral care product within 2 weeks of Screening that, in the opinion of the investigator or dentally qualified designee, could affect plaque formation or gingival health. 3. Currently taking a systemic medication (e.g., anti-inflammatory, anticoagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (e.g., ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers). 4. Smokes or uses smokeless forms of tobacco (example \[e.g.\] chewing tobacco, gutkha, pan containing tobacco, e-cigarettes \[vapes\]). 5. Is diagnosed with xerostomia or who the investigator believes might suffer from xerostomia based upon medications or oral examination. 6. Has a tongue or lip piercing, or any other oral feature that, in the opinion of the investigator, could interfere with the proper usage of a toothbrush. 7. Has, in the opinion of the investigator or medically qualified designee, signs of active periodontal disease or who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening. 8. Requires immediate dental intervention to resolve any oral condition. 9. Has dentures (partial or full) or has an orthodontic appliance (bands, appliances, or fixed/ removable retainers) that, in the opinion of the investigator, could interfere with the proper usage of a toothbrush. 10. A participant who has had teeth bleaching within 12 weeks of Screening. * A participant who has previously been enrolled in this study. * A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Where it's running
-
University of Birmingham
Birmingham, United Kingdom Recruiting
Study contacts
- Principal investigator: Praveen Sharma — University of Birmingham
- Study coordinator: Haleon Response Center
- Email: ww.clinical-trial-register@haleon.com
- Phone: +441932 95 95 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.