To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms

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.