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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Completed
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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