Last updated: 11/07/2018 12:31:18
The effect of experimental dentifrices on remineralization of caries lesions in-situ
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: The effect of experimental dentifrices on remineralization of caries lesions in-situ
Trial description: This study will evaluate the effect of experimental sodium fluoride-silica dentifrice formulations, with and without zinc, on remineralization of enamel in situ. Following the remineralization phase, the acid resistance of the new mineral formed will be assessed. Fluoride uptake during the remineralization phase will also be measured.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Percentage Surface Microhardness Recovery (% SMHR)
Timeframe: Baseline to 4 hours
Secondary outcomes:
Enamel Fluoride Uptake
Timeframe: Baseline to 4 hours
Percentage Net Acid Resistance (% NAR)
Timeframe: Baseline to 4 hours
Percentage Comparative Acid Resistance (% CAR)
Timeframe: Baseline to 4 hours
Interventions:
Enrollment:
62
Primary completion date:
2014-18-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Caries Res 2018;52:129-138 (DOI:10.1159/000479823)
Medical condition
Oral Hygiene
Product
sodium fluoride
Collaborators
Not applicable
Study date(s)
June 2014 to August 2014
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Good general health with no clinically significant and relevant abnormalities of medical history or oral examination
- Participants with maxillary dental arch suitable for the retention of the palatal appliance
- Participants taking fluoride supplement
- Pregnant or breast-feeding women
Inclusion and exclusion criteria
Inclusion criteria:
- Good general health with no clinically significant and relevant abnormalities of medical history or oral examination
- Participants with maxillary dental arch suitable for the retention of the palatal appliance
Exclusion criteria:
- Participants taking fluoride supplement
- Pregnant or breast-feeding women
Trial location(s)
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
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
Study complete
Actual primary completion date
2014-18-08
Actual study completion date
2014-18-08
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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