Last updated: 11/03/2018 22:19:37
A pooled analysis of Surface Micro Hardness (SMH) and Enamel Fluoride Uptake (EFU) from three studies involving a sodium fluoride salt in combination with Carbopol
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A pooled analysis of Surface Micro Hardness (SMH) and Enamel Fluoride Uptake (EFU) from three studies involving a sodium fluoride salt in combination with Carbopol
Trial description: The statistical analysis plan will describe the statistical methods and presentations of surface microhardness (SMH) and enamel fluoride uptake (EFU) from the summary and analysis of the final data pooled together from different studies looking at a combination of sodium fluoride with Carbopol
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean enamel fluoride uptake
Timeframe: Baseline to 14 days
Mean percent surface micro hardness (SMH) averaged over two enamel specimen
Timeframe: Baseline to 14 days
Secondary outcomes:
Not applicable
Interventions:
Drug: Sodium fluoride toothpaste(1450 ppmF)
Drug: Stannous Fluoride 1450 ppmF
Drug: Sodium Fluoride + Sodium Monofluorophosphate 1450 ppmF
Drug: Amine Fluoride 1400 ppmF
Drug: Sodium Monofluorophosphate 1450 ppmF
Drug: No fluoride 0 ppmF
Drug: Sodium fluoride toothpaste 675 ppmF
Drug: Sodium Fluoride 1400 ppmF
Enrollment:
202
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
dental caries
Product
SKF46655, SKF46656, sodium fluoride
Collaborators
Not applicable
Study date(s)
August 2014 to November 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 80 Year
Accepts healthy volunteers
yes
- Data from participants included in the per protocol population of the three studies.
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Data from participants included in the per protocol 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
Clinical study report
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
2014-05-11
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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