Last updated: 11/04/2018 10:25:16
Clinical efficacy of a toothpaste in providing relief from the pain of dentinal hypersensitivity
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2012-31-05
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)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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