A Clinical Study to Evaluate the Effectiveness of an Experimental Toothpaste in Improving Gum Health and Reducing Plaque Accumulation
NCT ID: NCT07255040
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2025-11-19
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Test Dentifrice
Participants will be instructed to brush their teeth thoroughly with Test Dentifrice for at least one (timed) minute twice a day (morning and evening) for 24 weeks.
Test Dentifrice
Experimental dentifrice containing 0.454% w/w SnF2.
Reference Dentifrice (Positive Control)
Participants will be instructed to brush their teeth thoroughly with Reference Dentifrice (Positive Control) for at least one (timed) minute twice a day (morning and evening) for 24 weeks.
Parodontax Complete Protection
Marketed dentifrice containing 0.454% w/w SnF2.
Reference Dentifrice (Negative Control)
Participants will be instructed to brush their teeth thoroughly with Reference Dentifrice (Negative Control) for at least one (timed) minute twice a day (morning and evening) for 24 weeks.
Colgate Cavity Protection
Marketed regular fluoride dentifrice.
Interventions
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Test Dentifrice
Experimental dentifrice containing 0.454% w/w SnF2.
Parodontax Complete Protection
Marketed dentifrice containing 0.454% w/w SnF2.
Colgate Cavity Protection
Marketed regular fluoride dentifrice.
Eligibility Criteria
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Inclusion Criteria
* Participant is of either sex and any gender who, at the time of screening, is at least 18 years old, inclusive.
* A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures.
* A participant 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.
Exclusion Criteria
* 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, psychiatric condition or laboratory abnormality or any other clinical serious or unstable conditions (example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) 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 female participant who is a pregnant (self-reported) or intending to become pregnant over the duration of the study or who is breastfeeding.
* 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 who is a current smoker or an ex-smoker (including vaping) who stopped within 6 months of Screening or who is using smokeless forms of tobacco (example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
* A participant who is diagnosed with xerostomia or is taking any medication that in the view of the investigator is causing xerostomia.
* A participant who has a medical condition which could have directly influenced gingival bleeding (example, type 2 diabetes) or who has a bleeding disorder that could have affected study outcomes and/or participant safety.
* A participant who has a recent history (within the last year) of alcohol or other substance abuse.
* A participant who has a severe oral condition (example, acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant/examiner if they participate in the study.
* Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush.
* Dental Exclusions:
1. A participant who has active caries that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.
2. A participant who has dentures (partial or full).
3. A participant who has fixed orthodontic appliances or is undergoing active or recent (within 3 months of Screening) orthodontic treatment, which in the opinion of the investigator, could interfere with study procedures, assessments or outcomes.
4. A participant who has other orthodontic devices (example, bands, fixed retainers, or removable retainers) that could, in the opinion of the investigator, interfere with study procedures, assessment or outcomes.
5. A participant who has numerous restorations in a poor state of repair.
6. A participant who has any dental condition (example, overcrowding) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.
7. A participant who has had dental prophylaxis within 12 weeks of Screening.
8. A participant who has had teeth bleaching within 12 weeks of Screening.
9. A participant who has high levels of extrinsic stain or calculus deposits, in the opinion of the investigator, that could have interfered with plaque assessments.
* 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.
18 Years
ALL
Yes
Sponsors
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HALEON
INDUSTRY
Responsible Party
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Locations
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Salus Research, Inc.
Fort Wayne, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Jeffery L Milleman
Role: primary
Other Identifiers
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400034
Identifier Type: -
Identifier Source: org_study_id