Conditions: Dental Caries
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 80
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 1: Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride arm 2: Twice daily brushing with a non-fluoride (placebo) toothpaste arm 3: Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride arm 4: Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.

Interventions: intervention 1: Fluoride free toothpaste intervention 2: Fluoride toothpaste intervention 3: Fluoride mouthwash
Intervention descriptions: intervention 1: Brushing with fluoride free toothpaste intervention 2: Brushing with fluoride containing toothpaste intervention 3: 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

Protocol document: