Clinical trial NCT02207907: To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste
Official title: A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Hygiene
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-08-04
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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 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.

Primary outcomes:
measure: Number of Gingival Bleeding Sites at 24 Weeks
timeFrame: Baseline, 24 weeks
measure: Modified Gingival Index (MGI) at 24 Weeks
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Number of Gingival Bleeding Sites at 6 and 12 Weeks.
timeFrame: Baseline, 6 and 12 weeks
measure: Modified Gingival Index (MGI) at 6 and 12 Weeks.
timeFrame: Baseline, 6 and 12 weeks
measure: Bleeding Index at 6, 12 and 24 Weeks
timeFrame: Baseline, 6, 12 and 24 weeks
measure: Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
timeFrame: Baseline, 6,12 and 24 weeks
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: