Last updated: 11/04/2018 10:25:24

The efficacy of a dentifrice in providing relief from the pain of dentinal hypersensitivity

GSK study ID
RH01325
See study documents
Clinicaltrials.gov ID
NCT01592864
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 clinical study investigating the efficacy of a dentifrice in providing long term relief from dentinal hypersensitivity
Trial description: A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over an eight week treatment period.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:

Mean change from baseline in evaporative air sensitivity pain response on a Schiff sensitivity scale at Week 8

Timeframe: Baseline to 8 weeks post administration of study treatment

Secondary outcomes:

Mean change from baseline in evaporative air sensitivity pain response on a Schiff sensitivity scale at Week 4

Timeframe: Baseline to 4 weeks post administration of study treatment

Adjusted mean change from baseline in tactile sensitivity pain response at Week 8

Timeframe: Baseline to 8 weeks post administration of study treatment

Adjusted mean change from baseline in tactile sensitivity pain response at Week 4

Timeframe: Baseline to 4 weeks post administration of study treatment

Interventions:
  • Drug: Stannous Fluoride
  • Drug: Sodium Monofluorophosphate
    • Enrollment:
    120
    Primary completion date:
    2012-31-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Dentine Hypersensitivity
    Product
    sodium monofluorophosphate, stannous fluoride
    Collaborators
    Not applicable
    Study date(s)
    March 2012 to May 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Subjects who suffer from tooth sensitivity
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Subjects who suffer from tooth sensitivity Inclusion Criteria:
    • none

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    BioSci Research America, Inc.
    Las Vegas, NV, United States, 89121
    Status
    Study Complete
    Contact us

    Study documents

    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2012-31-05
    Actual study completion date
    2012-31-05

    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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