Last updated: 11/04/2018 00:53:38

A Post-hoc Pooled Analysis of Clinical Data Investigating the Efficacy of an Occluding Dentifrice in Providing Relief from Dental Hypersensitivity

GSK study ID
208734
See study documents
Clinicaltrials.gov ID
Not applicable
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 Post-hoc Pooled Analysis of Clinical Data Investigating the Efficacy of an Occluding Dentifrice in Providing Relief from Dental Hypersensitivity
Trial description: The aim of this analysis was to pool data from 3 GSK studies with the same clinical design to investigate the overall efficacy of a test dentifrice containing 0.454 percent (%) weight by weight (w/w) stannous fluoride in providing relief from Dentinal Hypersensitivity (DH) after 3 days twice daily use, and after an initial direct application (‘dab-on’) to the cervical margin, against that of a regular fluoride dentifrice. The pooled analysis was planned and conducted after completion of all three independent studies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change from baseline in mean Schiff sensitivity score at Day 3

Timeframe: At Baseline, Day 3

Secondary outcomes:

Change from baseline in mean tactile threshold score at Day 3

Timeframe: At Baseline, Day 3

Change from baseline in mean Schiff sensitivity score after a single 60 second direct application

Timeframe: At Baseline, 60 seconds post first treatment

Change from baseline in mean tactile threshold after a single 60 second direct application

Timeframe: At Baseline, 60 seconds post first treatment

Interventions:
  • Drug: 0.454% w/w Stannous fluoride (1100 ppm fluoride)
  • Drug: 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride)
    • Enrollment:
    667
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Dentin Sensitivity
    Product
    SKF46655, SKF46656
    Collaborators
    Not applicable
    Study date(s)
    September 2017 to October 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18Years - 65Years
    Accepts healthy volunteers
    Yes
    • Data from participants included in the ITT population of the three studies.
    • Not applicable
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Data from participants included in the ITT population of the three studies.
    Exclusion criteria:
    • Not applicable

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

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

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2017-02-10

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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