To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms
Condition: Oral Hygiene
Intervention: Sodium bicarbonate and sodium fluoride; Sodium fluoride
Intervention description: Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride; Comparator toothpaste containing 1100 ppm fluoride as sodium fluoride
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily
      use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate
      toothpaste after 24 weeks of use. The study will be conducted at Salus Research, Inc.
      Participants will be recruited from their database and by use of an external recruitment
      agency
    

Eligibility criteria:

        Inclusion Criteria:

          -  Good general health with (in the opinion of the investigator) no clinically
             significant and relevant abnormalities of medical history or oral/dental examination.

          -  A minimum of 20 permanent gradable teeth

          -  Moderate gingivitis present at the screening visit in the opinion of the investigator

          -  A total of 20 bleeding sites or greater at baseline visit

          -  Positive response to bleeding on brushing present at the screening visit

        Exclusion Criteria:

          -  Pregnant or breast feeding women

          -  Tobacco chewers

          -  Current or relevant history of any serious, severe or unstable physical or psychiatric
             illness or any other medical condition (e.g. Diabetes Mellitus) that would make the
             participant unlikely to fully complete the study or any that increases the risk to the
             participant or undermines the data validity.

          -  Recent history (within the last year) of alcohol or other substance abuse

          -  Participants requiring prophylactic antibiotic treatment prior to dental therapy

          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely
             related compounds) or any of their stated ingredients

          -  Have current active caries or any medical conditions which may directly influence
             gingival bleeding

          -  Use of concomitant or any systemic medication that, in the opinion of the
             investigator, might interfere with the outcome of the study or have an effect on
             gingival conditions within 14 days of gingival examinations

          -  Excessive calculus present that interferes with the probing examination for Gingival
             Bleeding Index

          -  Participation in another clinical study or receipt of an investigational drug or oral
             care product within 30 days of the screening visit

          -  An employee of the sponsor or the study site or members or their immediate family.