To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms
To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms
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
This study will be a single-centre, examiner blind, two treatment, parallel group, stratified
 (by baseline number of bleeding sites smoking status and bacterial sampling) randomized
 clinical study. At the screening visit, following provision of written informed consent,
 eligible participants will be provided with a standard toothpaste and toothbrush for brushing
 once in at the clinic and for approximately one week use at home until the baseline visit.
 Participants will be asked to abstain from brushing over a 12 hour period prior to the
 Baseline visit. At the baseline visit an oral soft tissue (OST) assessment, Modified Gingival
 Index (MGI) and Bleeding Index (BI), and then dental plaque assessment will be performed.
 Participants will be stratified according to their baseline number of bleeding sites, smoking
 status and whether selected for bacterial sampling. Participants will be then randomized into
 one of two treatment groups. After using, their assigned treatment twice daily at home for 6
 weeks (visit 3), 12 weeks (visit 4) and 24 weeks (visit 5), participants will return to the
 site with overnight plaque at approximately the same time of day as the Baseline visit if
 possible. Participants will undergo a full OST examination and the recording of any Adverse
 Events (AEs). Participants will then undergo MGI, BI followed by dental plaque assessment.
 Microbiological samples will be collected on a subset of 50 participants (Determined by first
 50 participants randomized).
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.