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Enamel Remineralization with Different Fluoride Salts
NCT01128946Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2009
- Primary completion
- Mar 2010
- Countries
- 1
- Sponsor
- GSK
- Modality
- DNA Intercalators/Alkylators
- Conditions
- dental caries
01
Overview
Phase 4, randomised, double-blind trial of stannous fluoride and sodium monofluorophosphate in dental caries (4 arms), sponsored by GSK. Primary endpoint: Percentage Surface Microhardness Recovery at 14 days. Started Nov 2009; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Fluoride Toothpaste 1 (NaF 1450)
Sodium fluoride (1450 ppm F)
Fluoride Toothpaste 2 (SnF + NaF)
Stannous fluoride (1100 ppm F) + Sodium fluoride
Fluoride Toothpaste 3 (NaMFP + NaF)
Sodium monofluorophosphate (1000 ppm F) + Sodium fluoride
Reference Dentifrice (Low NaF)
Sodium fluoride (Low F, likely 675 ppm)
03
Who it enrols
Healthy adults aged 18-80 with a removable mandibular partial denture and normal salivary flow, excluding those with active caries, periodontal disease, or recent antibiotic use.
04
Endpoints
Primary
Percentage Surface Microhardness Recovery
Secondary
Enamel Fluoride Uptake
05
Results
Primary endpoints met
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