Last updated: 11/04/2018 10:25:16

Clinical efficacy of a toothpaste in providing relief from the pain of dentinal hypersensitivity

GSK study ID
RH01324
See study documents
Clinicaltrials.gov ID
NCT01592851
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 short 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 a two week treatment period.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14

Timeframe: Baseline to Day 14

Secondary outcomes:

Change from Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale immediately post-treatment

Timeframe: Baseline to immediately post treatment administration

Change from Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3

Timeframe: Baseline to Day 3

Change from Baseline in Tactile Pain Threshold Score at Day 14

Timeframe: Baseline to Day 14

Change from Baseline in Tactile Pain Threshold Score at Day 3

Timeframe: Baseline to Day 3

Change from Baseline in Tactile Pain Threshold Score immediately post-treatment

Timeframe: Baseline to immediately post treatment administration

Interventions:
  • Drug: Stannous Fluoride
  • Drug: Sodium Monofluorophosphate
    • Enrollment:
    113
    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)
    April 2012 to May 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Subjects who suffer from tooth sensitivity.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects who suffer from tooth sensitivity.

    Trial location(s)

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