Last updated: 11/07/2018 12:30:50

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

GSK study ID
202193
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Clinicaltrials.gov ID
NCT02207400
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and its Effect on Opportunistic or Resistant Organisms
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:

Number of Gingival Bleeding Sites at 24 Weeks

Timeframe: 24 weeks

Modified Gingival Index (MGI) at 24 Weeks

Timeframe: 24 weeks

Secondary outcomes:

Number of Gingival Bleeding sites at 6 and 12 Weeks

Timeframe: Baseline, 6 and 12 weeks

Modified Gingival Index (MGI)) at 6 and 12 Weeks.

Timeframe: 6 and 12 weeks

Bleeding Index (BI) at 6, 12 and 24 weeks

Timeframe: 6, 12 and 24 weeks

Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.

Timeframe: 6, 12 and 24 weeks

Bacterial Count at baseline, after 6, 12, 24 and 32 weeks

Timeframe: Baseline, 6, 12, 24 and 32 weeks

Interventions:
  • Drug: Sodium bicarbonate and sodium fluoride
  • Drug: Sodium fluoride
    • Enrollment:
    246
    Primary completion date:
    2015-30-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    J Clin Dent 2018;29:33–39
    Medical condition
    Oral Hygiene
    Product
    GSK3413212, sodium bicarbonate, sodium fluoride
    Collaborators
    Not applicable
    Study date(s)
    August 2014 to April 2015
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • 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
    • Pregnant or breast feeding women
    • Tobacco chewers
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Fort Wayne, Indiana, United States, 46825
    Status
    Study Complete
    Contact us

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2015-30-04
    Actual study completion date
    2015-30-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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