Last updated: 03/10/2021 06:30:22

Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief from Dentinal Hypersensitivity

GSK study ID
202196
See study documents
Clinicaltrials.gov ID
NCT02226562
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 Mouthwash in Providing Long Term Relief from Dentinal Hypersensitivity
Trial description: The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth) study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:

Mean change from baseline in Schiff sensitivity score at week 8

Timeframe: Baseline to 8 week

Secondary outcomes:

Mean change from baseline in Schiff sensitivity score at week 4

Timeframe: Baseline to 4 week

Mean change from baseline in tactile threshold at week 8

Timeframe: Baseline to 8 week

Mean change from baseline in tactile threshold at week 4

Timeframe: Baseline to 4 week

Mean change from baseline in Visual Rating Scale (VRS) at week 8

Timeframe: Baseline to 8 week

Mean change from baseline in VRS at week 4

Timeframe: Baseline to 4 week

Interventions:
  • Drug: Potassium nitrate and sodium fluoride
  • Drug: Standard fluoride dentifrice
    • Enrollment:
    191
    Primary completion date:
    2014-05-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Hall C, Sufi F, Milleman JL, Milleman KR. Efficacy of a 3% potassium nitrate mouthrinse for the relief of dentinal hypersensitivity: An 8-week randomized controlled study. J Am Dent Assoc. 2019 Mar;150(3):204-212. doi: 10.1016/j.adaj.2018.10.023. PMID:30803493
    Medical condition
    Dentin Sensitivity
    Product
    SKF46656, potassium nitrate, potassium nitrate/sodium fluoride, sodium fluoride
    Collaborators
    Not applicable
    Study date(s)
    September 2014 to December 2014
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Participants in good general health, 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 in good general health, 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 four, non-adjacent teeth. 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 participant 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.
    • In the 8 weeks prior to screening use of an oral care product indicated for the relief of DH.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Fort Wayne, Indiana, United States, 46825
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2014-05-12
    Actual study completion date
    2014-05-12

    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

    Participate in clinical trial
    Additional information
    Efficacy of a 3% potassium nitrate mouthrinse for the relief of dentinal hypersensitivity.
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    Access to clinical trial data by researchers
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