A Clinical Study Investigating the Effect of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health

Exclusion Criteria

• •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 has any other clinical serious or unstable conditions (for example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study outcomes and/or participant safety.
• •A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.
• •A participant who is breastfeeding.
• •A participant with known or suspected intolerance or hypersensitivity to any 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 vaper) who stopped within 6 months of Screening.
• •A participant who is using smokeless forms of tobacco (for example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
• •A participant who is diagnosed 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.
• •A participant 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 (for 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.
• •Medications exclusions: At Screening (Visit 1):
• •1. A participant using any antibiotic medication within 28 days prior to screening or at any time during the study.
• •2. Participant who has used an anti-bacterial toothpaste/mouthwash (for example, chlorhexidine) or another oral care product within 2 weeks of Screening that, in the opinion of the investigator or dentally qualified designee, could affect gingival health, plaque formation or oral bacteria.
• •3. A participant currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition.
• •4. A participant currently taking a systemic medication (for example, anti-inflammatory, anticoagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers, statins).
• •Medications exclusions: At Baseline (Visit 2):
• •1. A participant who has taken any antibiotics during the washout period (between Screening and Baseline).
• •2. A participant who has taken (in the previous 14 days) a systemic medication (for example, anti-inflammatory, anti-coagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
• •3. A participant who has used an antibacterial dentifrice or mouthwash (for example, chlorhexidine) or any oral care product that in the view of the investigator could interfere with gingival health, plaque formation and oral bacteria, in the period between Screening and the Baseline visit.
• •Periodontal exclusions:
• •1. A participant who shows signs of periodontitis \[at both Screening (Visit 1) and Baseline visits (Visit 2)\].
• •2. A participant with a Basic Periodontal Examination (BPE) score of 4 or above in one or more sextants.
• •3. A participant with BPE score \>= 3, if with probing pocket, a single tooth dept is \>= 5 mm.
• •4. A participant who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening.
• •5. A participant who has gingivitis, which in the opinion of the investigator, is not expected to respond to treatment with an over the counter (OTC) dentifrice.
• •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 an orthodontic appliance (bands, appliances, or fixed/ removable retainers).
• •4. A participant who received orthodontic therapy within 3 months of Screening.
• •5. A participant who has numerous restorations in a poor state of repair.
• •6. A participant who has any dental condition (for 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.