Overview

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

Status:
Completed
Trial end date:
2015-04-30
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Fluorides
Listerine
Sodium Fluoride
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.