Last updated: 11/04/2018 13:50:43

A clinical study to evaluate the efficacy of a dentifrice in reducing dentinal hypersensitivity

GSK study ID
Z7211049
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 clinical study to evaluate the efficacy of a dentifrice in reducing dentinal hypersensitivity
Trial description: The aim of this study is to evaluate and compare the effectiveness of an occluding dentifrice to a control dentifrice in the treatment of dentine hypersensitivity after a "dab on" application followed by twice daily use brushing over 3 days.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Evaporative (air) sensitivity measured via the Schiff Scale

Timeframe: Approximately 5 minutes post treatment application

Secondary outcomes:

Tactile sensitivity measured via Yeaple

Timeframe: Approximately 5 minutes post treatment application

Interventions:
  • Device: Occluding Toothpaste
  • Drug: Non-occluding toothpaste
    • Enrollment:
    88
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Dentin Sensitivity
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    November 2010 to December 2010
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 50 Year
    Accepts healthy volunteers
    none
    • Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history
    • Self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years
    • Known of suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
    • Participation in another clinical study or receipt of an investigational drug within 30 days prior to the screening visit
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history
    • Self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years
    Exclusion criteria:
    • Known of suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
    • Participation in another clinical study or receipt of an investigational drug within 30 days prior to the screening visit
    • Participation in a desnsitizing treatment study within 12 weeks of the screening visit
    • Previous participation in this study

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2010-11-12

    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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