A Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks

Last updated: February 28, 2025
Sponsor: HALEON
Overall Status: Completed

Phase

N/A

Condition

Periodontitis

Treatment

Sodium fluoride toothpaste

Stannous fluoride toothpaste

Clinical Study ID

NCT06143670
300107
  • Ages > 18
  • All Genders

Study Summary

The purpose of this clinical study is to investigate the efficacy of a dentifrice containing 0.454 percent (%) weight by weight (w/w) stannous fluoride (SnF2), on gingivitis treatment and plaque reduction, compared to a regular fluoride dentifrice after 12 weeks twice daily brushing in a population of clinically diagnosed gingivitis without undergoing dental prophylaxis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant provision of a signed and dated informed consent document indicatingthat the participant has been informed of all pertinent aspects of the study beforeany assessment is performed.

  • Participant is of either sex and any gender who, at the time of screening, is atleast 18 years old, inclusive.

  • A participant who is willing and able to comply with scheduled visits, treatmentplan, and other study procedures.

  • A participant in good general and mental health with, in the opinion of theinvestigator or medically qualified designee, no clinically significant/relevantabnormalities in medical history or upon oral examination, or condition, that wouldimpact the participant's safety, wellbeing or the outcome of the study, if they wereto participate in the study, or affect the participant's ability to understand andfollow study procedures and requirements.

  • Participant oral health that meets all the following:

At Screening (Visit 1):

  1. Participant with at least 20 natural, permanent teeth.

  2. Participant with at least 40 evaluable surfaces for MGI, BI, and TPI (An evaluablesurface is defined as having two thirds of the natural tooth surface gradable forthe selected clinical indices. The following will not be included in the evaluablesurface count: third molars; fully crowned/extensively restored, grossly carious,orthodontically banded/bonded or abutment teeth; surfaces with calculus depositswhich, in the opinion of the clinical examiner, would interfere with the baselineassessments of the selected clinical indices).

  3. A participant with plaque-induced gingivitis, in the opinion of the clinicalexaminer, as confirmed by a gross visual examination. At Baseline (Visit 2):

  4. A participant with ongoing hard tissue eligibility and, in the opinion of theclinical examiner, at least 40 evaluable surfaces.

  5. A participant with 10% to 30% bleeding sites (following BI).

  6. A participant with mean whole mouth TPI score >=1.5.

Exclusion

Exclusion Criteria:

  • A participant who is an employee of the investigational site, either directlyinvolved in the conduct of the study or a member of their immediate family; or anemployee of the investigational site otherwise supervised by the investigator; or, asponsor's employee directly involved in the conduct of the study or a member oftheir immediate family.

  • A participant who has participated in other studies (including non-medicinalstudies) involving investigational product(s) within 30 days prior to study entryand/or during study participation.

  • A participant with, in the opinion of the investigator or medically qualifieddesignee, an acute or chronic medical or psychiatric condition or laboratoryabnormality that may increase the risk associated with study participation orinvestigational product administration or may interfere with the interpretation ofstudy results and, in the judgment of the investigator or medically qualifieddesignee, would make the participant inappropriate for entry into this study.

  • A participant who has any other clinical serious or unstable conditions (forexample, cardiovascular diseases, diabetes, liver disorders, and kidney disorders)which could have affected study outcomes and/or participant safety.

  • A participant who is a pregnant female (self-reported) or is intending to becomepregnant over the duration of the study.

  • A participant who is a breastfeeding female.

  • A participant who is known or suspected intolerance or hypersensitivity to the studymaterials (or closely related compounds) or any of their stated ingredients.

  • A participant who is unwilling or unable to comply with the lifestyleconsiderations.

  • Participant who is a current smoker or an ex-smoker who stopped within 6 months ofScreening.

  • 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 theview of the investigator is causing xerostomia.

  • A participant who has a medical condition which could have directly influencedgingival bleeding (for example, type 2 diabetes).

  • A participant who has a bleeding disorder that could have affected study outcomesand/or participant safety.

  • A participant who has a recent history (within the last year) of alcohol or othersubstance abuse.

  • A participant who has a severe oral condition (for example, acute necrotizingulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions)that could, in the opinion of the investigator, compromise study outcomes or theoral 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 interferewith the usage of a toothbrush.

  • Medication exclusions at screening (Visit 1):

  1. A participant using any antibiotic medication within 14 days prior to screeningor at any time during the study.

  2. A participant currently taking an anti-inflammatory medication which, in theopinion of the Investigator, could affect gingival condition.

  3. A participant currently taking a systemic medication (for example,anti-inflammatory, anticoagulant, immunosuppressants) or traditional/ herbalremedy which, in the opinion of the Investigator, could affect plaque/ gingivalcondition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin,calcium channel blockers).

  • Medication exclusions at Baseline (Visit 2):
  1. A participant who has taken (in the previous 14 days), any antibiotics.

  2. A participant who has taken (in the previous 14 days) a systemic medication (for example, anti-inflammatory, anti-coagulant, immunosuppressants) ortraditional/ herbal remedy which, in the opinion of the Investigator, couldaffect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin,cyclosporin, phenytoin, calcium channel blockers).

  3. A participant who has used an antibacterial dentifrice or mouthwash (forexample, chlorhexidine) or any oral care product that in the view of theinvestigator could interfere with plaque formation or measures of gingivitis,in the period between Screening and the Baseline visit.

  • Periodontal exclusions:
  1. A participant who shows signs of active periodontitis (with probing pocketdepths greater than [>] 3mm).

  2. A participant who is receiving or has received treatment for periodontaldisease (including surgery) within 12 months of Screening.

  3. A participant who has gingivitis, which in the opinion of the investigator, isnot 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 theinvestigator, compromise study outcomes or the oral health of the participantif 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) thatcould, in the opinion of the investigator, compromise study outcomes or theoral 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, inthe opinion of the investigator, that could have interfered with plaqueassessments.

  • A participant who has previously been enrolled in this study.

  • A participant who, in the opinion of the investigator or medically qualifieddesignee, should not participate in the study.

Study Design

Total Participants: 159
Treatment Group(s): 2
Primary Treatment: Sodium fluoride toothpaste
Phase:
Study Start date:
November 29, 2023
Estimated Completion Date:
March 12, 2024

Study Description

This will be a single center, randomized, controlled, single blind (examiner blind), two-treatment arm, parallel study. Study participants will be over 18 years old, non-smokers, in good general health with clinically measurable levels of gingivitis that meet all study criteria at the Screening and Baseline visits. Approximately 160 participants (approximately 80 per group) will be randomized to ensure approximately 144 evaluable participants (approximately 72 per group) complete the study.

Connect with a study center

  • Salus Research

    Fort Wayne, Indiana 46825
    United States

    Site Not Available

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