Conditions: Dental Erosion
Keywords: enamel fluoride uptake erosion enamel remineralization
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: yes

Brief summary:
The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries

Detailed description:
Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate enamel demineralization and remineralization during the caries process. Determination of fluoride uptake in-situ also provides better estimation of true fluoride bioavailability of fluoride dentifrice products. In this study, an in-situ remineralization fluoride uptake model will be used to compare the efficacy of experimental dentifrice with a marketed dentifrice and placebo dentifrice. Participants wore partial dentures containing two partially demineralized enamel specimens for two weeks- 24 hours per day, except when brushing (twice daily) with test dentifrice. Following each treatment period, the enamel specimens were analyzed for SMH recovery and fluoride uptake through microdrill enamel biopsy technique.

Arms:
arm 1: Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) and isopentane as an excipient ingredient. arm 2: Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane. arm 3: Participants to brush their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF. arm 4: Participants to brush their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).

Interventions: intervention 1: NaF/ KNO3/isopentane Dentifrice intervention 2: NaF/KNO3 Dentifrice intervention 3: NaF Dentifrice intervention 4: Placebo Dentifrice
Intervention descriptions: intervention 1: Experimental toothpaste intervention 2: Experimental toothpaste intervention 3: Active comparator intervention 4: Placebo comparator

Protocol document: