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
Study type: Interventional
Phase: Phase 4

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).
    

Detailed description: 
      This will be a single center, controlled, single blind (examiner blind), randomized,
      two-treatment arm, parallel design, clinical study in participants (aged 18-65 years), with
      good general health (non-smokers) and generalized mild-moderate plaque-induced gingivitis and
      greater than equal to (>=) 20 natural teeth. The study consists of 4 study visits. At Visit
      1, Screening, after signing informed consent, participants will be assessed for eligibility
      based on the inclusion/exclusion criteria and will undergo oral soft tissue (OST) and oral
      hard tissue (OHT) assessments. Participants will return between 1 and 28 days following the
      screening visit for the Visit 2, baseline where they will undergo, a full OST examination
      followed by assessments of gingival inflammation (MGI), gingival bleeding (BI) and
      supra-gingival plaque (TPI). Eligible participants will be stratified based on gender and
      baseline mean whole mouth MGI score (low: less than equal to (<=) 2.00/High greater than (>)
      2.00), to ensure a balance of gingivitis across both treatment groups and then randomized to
      study product. All randomized participants will receive full mouth dental prophylaxis
      (followed by flossing) to remove sub and supra-gingival calculus, stain, plaque and debris
      from the teeth. All participants will enter the treatment period with no visible plaque
      (TPI=0). After all clinical assessments, participants will be instructed to brush for 1 timed
      minute at site with their assigned study product, after which they will be instructed to
      continue using this twice daily (morning and evening) for 2 weeks. After 2 weeks the
      participants will return to site for their Week 2 (Visit 3) assessments. They will then
      continue using their test dentifrice for a further week and will continue to record all
      brushing events in the diary provided, after which they will return for their Week 3 (Visit
      4) assessments. All assessments will be carried out on the facial and lingual/palatal
      surfaces of each incisor, canine, pre-molar and molar, excluding third molars. After the Week
      3 visit, study closeout procedures will take place and the participant may undergo an
      additional prophylaxis if it is deemed necessary by the examiner. Adverse events and
      incidents will be recorded from informed consent and at the end of each study visit.
    

Intervention name(s): Sensodyne Repair and Protect; Colgate Cavity Protection
Intervention type(s): Drug; Drug
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment