Last updated: 11/04/2018 00:53:38
A Post-hoc Pooled Analysis of Clinical Data Investigating the Efficacy of an Occluding Dentifrice in Providing Relief from Dental Hypersensitivity
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A Post-hoc Pooled Analysis of Clinical Data Investigating the Efficacy of an Occluding Dentifrice in Providing Relief from Dental Hypersensitivity
Trial description: The aim of this analysis was to pool data from 3 GSK studies with the same clinical design to investigate the overall efficacy of a test dentifrice containing 0.454 percent (%) weight by weight (w/w) stannous fluoride in providing relief from Dentinal Hypersensitivity (DH) after 3 days twice daily use, and after an initial direct application (‘dab-on’) to the cervical margin, against that of a regular fluoride dentifrice. The pooled analysis was planned and conducted after completion of all three independent studies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change from baseline in mean Schiff sensitivity score at Day 3
Timeframe: At Baseline, Day 3
Secondary outcomes:
Change from baseline in mean tactile threshold score at Day 3
Timeframe: At Baseline, Day 3
Change from baseline in mean Schiff sensitivity score after a single 60 second direct application
Timeframe: At Baseline, 60 seconds post first treatment
Change from baseline in mean tactile threshold after a single 60 second direct application
Timeframe: At Baseline, 60 seconds post first treatment
Interventions:
Drug: 0.454% w/w Stannous fluoride (1100 ppm fluoride)
Drug: 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride)
Enrollment:
667
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Dentin Sensitivity
Product
SKF46655, SKF46656
Collaborators
Not applicable
Study date(s)
September 2017 to October 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18Years - 65Years
Accepts healthy volunteers
Yes
- Data from participants included in the ITT population of the three studies.
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Data from participants included in the ITT population of the three studies.
Exclusion criteria:
- Not applicable
Trial location(s)
No location data available.
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2017-02-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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