Last updated: 11/04/2018 12:46:53

To investigate the clinical efficacy of an experimental toothpaste

GSK study ID
T3450803
Clinicaltrials.gov ID
NCT01079910
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Clinical efficacy of an experimental toothpaste
Trial description: The objective of this study is to evaluate the effect of an experimental toothpaste on maintaining gingival health over a 24 week period measured through modified gingival index, bleeding, plaque, and plaque bacteria. Prior to commencing study treatment, subjects will undergo a dental prophylaxis followed by a 2 week period of oral hygiene instruction and weekly professional tooth cleaning to bring the subjects to their optimum gingival health prior to commencing study treatment.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from baseline Modified Gingival Index at 24 weeks

Timeframe: baseline to 24 weeks

Change from baseline Bleeding Index at 24 weeks

Timeframe: baseline to 24 weeks

Secondary outcomes:

Change from baseline Modified Gingival Index at weeks 6 & 12

Timeframe: baseline to week 12

Change from baseline Bleeding Index at weeks 6 & 12

Timeframe: baseline to week 12

Change from baseline Plaque Index at weeks 6, 12 & 24

Timeframe: baseline to week 24

Change from baseline plaque bacteria at weeks 12 & 24

Timeframe: baseline to week 24

Interventions:
  • Drug: isopropylmethylphenol and Fluoride
  • Drug: Fluoride and Silica
    • Enrollment:
    0
    Primary completion date:
    2009-31-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Gingivitis
    Product
    sodium fluoride
    Collaborators
    Not applicable
    Study date(s)
    December 2009 to December 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Healthy subjects aged 18 years and older
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Healthy subjects aged 18 years and older
    • A minimum of 20 permanent gradable teeth
    • For baseline eligibility, subjects must have a minimum Modified Gingival Index score of 1.5-2.3.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    University Park Research Center (UPRC)
    Fort Wayne, IN, United States, 46825
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    2009-31-12
    Actual study completion date
    2009-31-12

    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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