Last updated: 11/04/2018 10:27:08

Investigating the Efficacy of a Dentifrice in Providing Long Term Relief from Dentinal Hypersensitivity

GSK study ID
RH01685
See study documents
Clinicaltrials.gov ID
NCT01827670
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: Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:

Mean change from Baseline in Schiff sensitivity score

Timeframe: Baseline-Week 8

Secondary outcomes:

Mean change from Baseline in Schiff sensitivity score

Timeframe: Baseline-Week 4

Mean change from Baseline in Tactile sensitivity

Timeframe: Baseline-Week 8

Mean change from Baseline in Tactile sensitivity

Timeframe: Baseline-Week 4

Mean change in Dentinal Hypersensitivity after 4 weeks as measured by Visual Analog Scale (VAS)

Timeframe: Baseline-Week 4

Mean change in Dentinal hypersensitivity after 8 weeks as measured by Visual Analog Scale (VAS)

Timeframe: Baseline - Week 8

Interventions:
  • Drug: Stannous fluoride
  • Drug: Sodium monofluorophosphate
    • Enrollment:
    119
    Primary completion date:
    2013-31-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Dentine Hypersensitivity
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    February 2013 to May 2013
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
    • Participants with minimum of 20 natural teeth.
    • Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
    • Any condition which, in the opinion of the investigator, causes dry mouth.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
    • Participants with minimum of 20 natural teeth.
    • At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria. a) Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. b) Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1. c) Teeth that are determined to be sensitive by the subject following a 1 second air blast to the cervical margin.
    Exclusion criteria:
    • Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
    • Any condition which, in the opinion of the investigator, causes dry mouth.
    • Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
    • Participant using of a desensitising dentifrice within 6 weeks of screening

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    Salus Research, Inc.
    Fort Wayne, IN, United States, 46825
    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
    2013-31-05
    Actual study completion date
    2013-31-05

    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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