Last updated: 11/03/2018 22:19:37

A pooled analysis of Surface Micro Hardness (SMH) and Enamel Fluoride Uptake (EFU) from three studies involving a sodium fluoride salt in combination with Carbopol

GSK study ID
202197
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 pooled analysis of Surface Micro Hardness (SMH) and Enamel Fluoride Uptake (EFU) from three studies involving a sodium fluoride salt in combination with Carbopol
Trial description: The statistical analysis plan will describe the statistical methods and presentations of surface microhardness (SMH) and enamel fluoride uptake (EFU) from the summary and analysis of the final data pooled together from different studies looking at a combination of sodium fluoride with Carbopol
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Mean enamel fluoride uptake

Timeframe: Baseline to 14 days

Mean percent surface micro hardness (SMH) averaged over two enamel specimen

Timeframe: Baseline to 14 days

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Sodium fluoride toothpaste(1450 ppmF)
  • Drug: Stannous Fluoride 1450 ppmF
  • Drug: Sodium Fluoride + Sodium Monofluorophosphate 1450 ppmF
  • Drug: Amine Fluoride 1400 ppmF
  • Drug: Sodium Monofluorophosphate 1450 ppmF
  • Drug: No fluoride 0 ppmF
  • Drug: Sodium fluoride toothpaste 675 ppmF
  • Drug: Sodium Fluoride 1400 ppmF
    • Enrollment:
    202
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    dental caries
    Product
    SKF46655, SKF46656, sodium fluoride
    Collaborators
    Not applicable
    Study date(s)
    August 2014 to November 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 80 Year
    Accepts healthy volunteers
    yes
    • Data from participants included in the per protocol population of the three studies.
    • Not applicable
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Data from participants included in the per protocol 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)
    Clinical study report
    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
    2014-05-11

    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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