Dental Caries
Conditions
Brief summary
This single-center, randomized, double-blind, three-period crossover in situ study evaluated the enamel remineralization potential and fluoride bioavailability of three dentifrices-one fluoride-free negative control, one positive control with 0.243% sodium fluoride, and one investigational dentifrice containing 0.243% sodium fluoride and 20% sodium bicarbonate. Healthy adult subjects wore a palatal acrylic appliance containing demineralized enamel specimens for three 9-day treatment periods, during which in vivo brushing/slurry exposure and ex vivo sucrose challenges were performed. Outcomes included percent surface microhardness recovery (%SMHR) and post-treatment enamel fluoride concentration.
Detailed description
This in situ intraoral appliance (IOA) model evaluates anticaries potential by exposing demineralized enamel specimens to oral conditions while allowing for ex vivo treatment assessments. Subjects wore acrylic palatal appliances containing four enamel specimens covered with steel gauze to promote plaque formation. Each of the three treatment periods lasted nine days and included twice-daily toothbrushing and dentifrice slurry swishing, plus three daily sucrose challenges. A minimum 4-day fluoride-free washout preceded each period. Post-treatment specimens were analyzed for %SMHR and enamel fluoride concentration.
Interventions
Fluoride-free toothpaste
DRUGActive Comparator
Commercially available fluoride toothpaste
DRUGTest Toothpaste
lnvestigational fluoride toothpaste
Sponsors
Church & Dwight Company, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults ≥18 years * Good general and oral health * Normal unstimulated salivary flow (≥1.5 mL/5 min) * Functional dentition * Oral conditions adequate to support the palatal appliance * Ability to comply with brushing, slurry, appliance wear, and sucrose challenge procedures
Exclusion criteria
* Inability to tolerate appliance * Oral pathology that interferes with participation * Antibiotic use that violates withdrawal criteria * Use of fluoride toothpaste during washout * Participation in another appliance study in the past 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Surface Microhardness Recovery (%SMHR) [Time Frame: End of each 9-day test period (three test periods in total)] | End of each 9#day test period (three test periods in total) |
| Post-treatment fluoride concentration (µg F/g enamel) | End of each 9-day test period (three test periods in total |
Countries
United States
Contacts
STUDY_DIRECTORAnnahita Ghassemi, PhD
Church & Dwight, Inc.
Outcome results
None listed