The study will evaluate and compare the potential anti-caries efficacy of a test regimen: placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to remineralize previously demineralized enamel specimens, as measured by Surface MicroHardness Recovery (%SMHR). This will be a single center, randomized, laboratory analyst blinded, placebo, four treatment, cross-over study in healthy participants. Participants will be assessed at baseline and at the beginning and end of each treatment visit to monitor clinical efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Brushing with fluoride free toothpaste
Brushing with fluoride containing toothpaste
Fluoride mouth wash to be followed after brushing with fluoride free toothpaste in "Placebo dentifrice/Fluoride rinse" arm and in "Fluoride dentifrice/Fluoride rinse" arm
GSK Investigational Site
Indianapolis, Indiana, United States
Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer \[μm\]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\]\*100.
Time frame: Baseline to 14 days
Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer \[μm\]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\]\*100.
Time frame: Baseline to 14 days
Enamel Fluoride Uptake
The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm\^2).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline to 14 days
Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14
Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 baseline prior to supervised treatment. - at day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample.
Time frame: Baseline to Day14
Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14
Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample.
Time frame: Baseline up to Day 14