A Phase 3 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice Containing Stannous Fluoride
Condition: Gingivitis
MeSH terms: Gingivitis
Intervention: Stannous fluoride; Sodium monofluorophosphate
Intervention description: In this arm, participants will apply a full ribbon of dentifrice ( 0.454% w/w stannous fluoride) to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings.; In this arm, participants will apply a full ribbon of negative control dentifrice (1000 ppm fluoride as SMFP to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings.
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Oral Health; Antiplaque; Gingivitis

Summary:

      The purpose of this study is to evaluate and compare the gingival health of a test dentifrice
      (0.454% weight by weight [w/w] stannous fluoride) to a negative control dentifrice by
      comparing modified gingival index, bleeding index and plaque index scores.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consent :Demonstrates understanding of the study and willingness to participate as
             evidenced by voluntary written informed consent and has received a signed and dated
             copy of the informed consent form.

          -  Compliance: Understands and is willing, able and likely to comply with all study
             procedures and restrictions.

          -  General Health: Good general and mental health with, in the opinion of the
             investigator, no clinically significant and relevant abnormalities of medical history
             or oral examination.

          -  Dental Health: A minimum of 20 natural teeth and a minimum of 40 gradable surfaces
             for: a) MGI, BI and PI. A scorable surface is defined as a surface that has 50% of the
             surface gradable. Third molars, orthodontically banded/ bonded, fully crowned or
             extensively restored or grossly carious teeth are not included in the tooth count; b)
             Moderate gingivitis present at the screening visit in the opinion of the investigator;
             c) Mean whole mouth MGI between 1.75 and 2.30 and mean whole mouth supra-gingival PI
             score 1.5 at Baseline Visit.

        Exclusion Criteria:

          -  Pregnancy and breast-feeding: Women who are known to be pregnant or who are intending
             to become pregnant or women who are breast-feeding over the duration of the study.

          -  Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients.

          -  Tobacco Use: Current smokers or smokers who have quit within the past six months,
             prior to screening, or participants currently using smokeless forms of tobacco - e.g.
             chewing tobacco.

          -  Concomitant Medications - Treatments Screening (Visit 1)

               1. Currently taking antibiotics or requiring antibiotic use prior to dental
                  prophylaxis or other dental procedures.

               2. Currently taking an anti-inflammatory medication which, in the opinion of the
                  Investigator, could affect gingival condition.

               3. Currently taking a systemic medication which, in the opinion of the Investigator,
                  could affect gingival condition (e.g. calcium channel blockers, or aspirin
                  therapy).

               4. Current use of a chlorhexidine mouthwash. Baseline (Visit 2)

               5. Currently taking antibiotics or taken antibiotics in the previous 14 days or
                  requiring antibiotic use prior to dental prophylaxis or other dental procedures.

               6. Has taken an anti-inflammatory medication which, in the opinion of the
                  investigator, could affect gingival condition in the previous 14 days.

               7. Has taken a systemic medication which, in the opinion of the investigator, could
                  affect gingival condition in the previous 14 days (e.g. calcium channel blockers,
                  or aspirin therapy).

          -  General Dentition Exclusions

               1. Current active caries or periodontitis that may, in the opinion of the
                  investigator, compromise the study outcomes or oral health of the participants if
                  they participate in the study.

               2. Restorations in a poor state of repair.

               3. Partial dentures or orthodontic appliances.

               4. Teeth bleaching within 12 weeks of screening.

          -  Clinical Study/Experimental Medication

               1. Participation in another clinical study or receipt of an investigational drug or
                  investigational oral care product within 30 days of the Baseline Visit.

               2. Previous participation in this study.

          -  Substance abuse: Recent history (within the last year) of alcohol or other substance
             abuse.

          -  Personnel:

               1. Employed by the sponsor or the study site or members of their immediate family.

               2. Employed by any dentifrice manufacturer or their immediate family.

          -  Other Conditions: Any condition that would impact on the safety of the participant or
             wellbeing or affect the individual's ability to understand and follow study procedures
             and requirements.