A Clinical Study Investigating the Efficacy of a Stannous Fluoride Dentifrice in Improving Gingival Health After Twice Daily Use for 3 Weeks
Condition: Gingivitis
MeSH terms: Gingivitis
Intervention: Sensodyne Repair and Protect; Colgate Cavity Protection
Intervention description: Participants will brush their teeth with Sensodyne Repair and Protect (containing 0.454% stannous fluoride) for 1 timed minute twice a day (morning and evening), for 3 weeks.; Participants will brush their teeth with Colgate Cavity Protection repair and protect (containing sodium fluoride) for 1 timed minute twice a day (morning and evening), for 3 weeks.
Intervention MeSH terms: Listerine; Sodium Fluoride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Single Blind
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of this study is to investigate the impact of a stannous fluoride containing
      toothpaste in reducing gingivitis when used twice daily for a maximum for 3 weeks, when
      compared to a standard sodium fluoride toothpaste (negative control).
    

Eligibility criteria:

        Inclusion Criteria:

        An individual must meet all the following inclusion criteria to be eligible for enrollment
        into the study:

          -  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 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.

          -  A participant at screening (Visit 1) with: a)at least 20 natural permanent teeth
             excluding 3rd molars; b)at least 40 evaluable surfaces (an evaluable surface is
             defined as having 2/3rds of the natural tooth surface gradable for the selected
             clinical indices. The following should not be included in the evaluable surface count-
             third molars; fully crowned/extensively restored, grossly carious, orthodontically
             banded/bonded or abutment teeth; surfaces with calculus deposits which, in the opinion
             of the clinical examiner, would interfere with the baseline assessments of the
             selected clinical indices); or c) participants with generalized mild-moderate
             plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by
             visual examinations.

          -  A participant at baseline (prior to dental prophylaxis, (Visit 2) with: a)ongoing hard
             tissue eligibility and, in the opinion of the clinical examiner, at least 40 evaluable
             surfaces; b) mean whole mouth Modified Gingival Index (MGI) greater than equal to (>=)
             1.75 to less than equal to (<=) 2.30; c) mean whole mouth supra-gingival Turesky
             Plaque Index (TPI) score ≥ 1.5; d) ≥ 20 bleeding sites.

        Exclusion Criteria:

        An individual who meets any of the following exclusion criteria will not be eligible for
        enrollment into the study:

          -  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
             GlaxoSmithKline 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 with, in the opinion of the investigator or medically qualified
             designee, any clinically significant/relevant abnormalities in medical history or oral
             examination, or any other condition, that would affect the individual's ability to
             understand and follow study procedures and requirements.

          -  A participant with any medical condition which, in the opinion of the investigator or
             medically qualified designee, is causing xerostomia.

          -  A participant with any medical condition which in the opinion of the investigator or
             medically qualified designee, could directly influence gingival bleeding.

          -  A participant who is pregnant or intending to become pregnant over the duration of the
             study (self-reported).

          -  A participant 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 with recent history (within the last year) of alcohol or other substance
             abuse.

          -  A participant who is a current smoker or an ex- smoker who stopped within 6 months of
             Screening.

          -  A participant who currently uses smokeless forms of tobacco (e.g. chewing tobacco,
             gutkha, pan containing tobacco, nicotine-based e-cigarettes).

          -  A participant with a severe oral condition (e.g. acute necrotizing ulcerative
             gingivitis or oral or peri-oral ulceration including herpetic lesions) that would, in
             the opinion of the investigator, compromise study outcomes or the oral health of the
             participant/ examiner if they were to participate in the study.

          -  A participant who has presence of a tongue or lip piercing, or any other oral feature
             that could interfere with the usage of a toothbrush

          -  A participant who, in the opinion of the investigator or medically qualified designee,
             should not participate in the study.

          -  A participant unwilling or unable to comply with the following Lifestyle
             Considerations (Dental Product/Treatment and Oral Hygiene Restrictions): a) From
             Screening (Visit 1) to the participants' last study visit- i) a participant should not
             carry out any interproximal dental cleaning. Use of dental floss, toothpicks,
             waterpicks or inter-dental brushes is prohibited (except for the removal of impacted
             food with non-antimicrobial products only), ii)participants should not chew gum or
             consume any confectionery containing xylitol (e.g. sugar-free mints), iii)participants
             should delay any non-emergency dental treatment until after study completion
             (including dental prophylaxis); b) From Baseline (Visit 2) to the participants last
             study visit- participants should not use any other oral care products (e.g.
             dentifrices, toothbrushes, mouth rinse) than those provided during the study; c)
             Before clinical efficacy assessment visits: Baseline (Visit 2), Week 2 (Visit 3) and
             Week 3 (Visit 4)- i) participant's should refrain from oral hygiene procedures for 12
             hours (+6 hours, -2 hours) before their visit and attend the study site with overnight
             plaque growth.

          -  A participant that has used an anti-bacterial mouthwash (e.g. chlorhexidine) or use of
             any oral care product that in the view of the investigator could interfere with plaque
             formation or measures of gingivitis, within 14 days of the Baseline visit.

          -  Periodontal Exclusions: a) participant with signs of active periodontitis; b)
             participant with gingivitis which, in the opinion of the investigator, is not expected
             to respond to treatment with an over-the-counter dentifrice; c) A participant who is
             receiving or has received treatment for periodontal disease (including surgery) within
             12 months of Screening.

          -  Dental Exclusions: a) participant with active caries that could, in the opinion of the
             investigator, compromise study outcomes or the oral health of the participant if they
             were to participate in the study; b )participant with dentures (partial or full); c)
             participant with an orthodontic appliance (bands, appliances or fixed/ removable
             retainers); d) A participant who has received orthodontic therapy within 12 months of
             screening; e) participant with numerous restorations in a poor state of repair; f)
             participant with any dental condition (e.g. overcrowding) that could, in the opinion
             of the investigator, compromise study outcomes or the oral health of the participant
             if they were to participate in the study; g) participant who has had dental
             prophylaxis within 12 weeks of Screening, h) participant who has had teeth bleaching
             within 12 weeks of Screening; i) A participant with high levels of extrinsic stain or
             calculus deposits that might interfere with plaque assessments. - Medication
             Exclusions: a )at screening (Visit 1)- i)participant who requires antibiotics prior to
             dental prophylaxis or other dental procedures, ii) participant who is currently taking
             antibiotics, iii) participant who is currently taking an anti-inflammatory medication
             which, in the opinion of the Investigator, could affect gingival condition (e.g.
             ibuprofen), iv) participant who is currently taking anti-coagulant medication which,
             in the opinion of the Investigator, could affect gingival condition (e.g. warfarin),
             v) participant who is currently taking a systemic medication or traditional/herbal
             remedy which, in the opinion of the Investigator, could affect gingival condition
             (e.g. immunosuppressants such as cyclosporine, phenytoin, calcium channel blockers,
             aspirin therapy); b) at baseline (Visit 2)- i) participant who has taken antibiotics
             in the 14 days prior to baseline, ii) participant who has taken an anti-inflammatory
             medication in the 14 days prior to baseline which, in the opinion of the Investigator,
             could affect gingival condition (e.g. ibuprofen), iii)participant who has taken
             anti-coagulant medication in the 14 days prior to Baseline which, in the opinion of
             the Investigator, could affect gingival condition (e.g. warfarin), iv)participant who
             has taken a systemic medication or traditional/herbal remedy in the 14 days prior to
             Baseline which, in the opinion of the Investigator, could affect gingival condition
             (e.g. immunosuppressants such as cyclosporine, phenytoin, calcium channel blockers,
             aspirin therapy), v) participant who has used an antibacterial dentifrice or mouth
             rinse in the period between Screening and Baseline.

          -  Any participant who has previously been enrolled in this study.

          -  Participants who, in the judgement of the investigator, or medically qualified
             designee should not participate on the study.