To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste
To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste
The primary objectives of this study will be to 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 Silverstone Research Group. Participants will be recruited from their database
 and by use of an external recruitment agency.
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
 participants 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.