Conditions: Caries
Keywords: fluoride in situ remineralization enamel caries
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 57
Healthy volunteers: yes

Brief summary:
This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model

Detailed description:
In situ models represent an acceptable approach for testing the anti-caries potential of fluoride products. This study is to evaluate the effect of fluoride dentifrice containing 1450 parts per million fluoride (ppm F) on enamel with artificial caries lesions in an in situ model. The study toothpaste containing sodium fluoride (NaF) and 0.4% carbopol will be compared to 4 other dentifrices. Comparator toothpastes include NaF toothpaste (1400 ppm F), NaF toothpaste (675 ppm F), sodium monofluorophosphate (NaMFP) and NaF toothpaste (1450 ppm F) and placebo toothpaste (0 ppm F).

Arms:
arm 1: Study toothpaste containing 1450 ppm F as NaF and 0.4% carbopol as excipient. arm 2: Study toothpaste containing 1400 ppm F as NaF arm 3: Reference toothpaste containing 1000 ppm F as NaMFP and 450 ppm F as NaF arm 4: Study toothpaste containing 675 ppm F as NaF arm 5: Fluoride free placebo toothpaste (0 ppm F)

Interventions: intervention 1: NaF intervention 2: Placebo intervention 3: NaMFP
Intervention descriptions: intervention 1: Fluoride intervention 2: Placebo intervention 3: Fluoride

Protocol document: