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: a fluoride-free negative control, a positive control with 0.243% sodium fluoride, and an investigational dentifrice containing 0.243% sodium fluoride, 5.0% potassium nitrate (KNO₃), and 20% sodium bicarbonate. Adult subjects wore acrylic palatal appliances containing demineralized enamel specimens for three 7-day treatment periods, each preceded by a 5-day fluoride-free washout. Primary outcomes were percent surface microhardness recovery (%SMHR) and 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 seven days and included twice-daily toothbrushing and dentifrice slurry swishing, plus three daily sucrose challenges. A minimum 5-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
Investigational 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 saliva flow (≥1.5 mL unstimulated saliva in 5 minutes) * ≥16 teeth and functional maxillary dentition to support palatal appliance * Agree to abstain from other oral care products and preventive dental procedures during study * No advanced periodontal disease, no visible untreated caries * If female, not pregnant or breastfeeding (self-reported) * No significant oral soft tissue pathology; no peri/oral piercings; no removable partial dentures * No antibiotics or immunosuppressives within 30 days of screening * No palatal torus; no medical condition that would interfere with safety * No allergy or significant adverse events to impression materials, acrylics, or common oral product
Exclusion criteria
* Unable to tolerate appliance or comply with procedures * Oral pathology that interferes with participation * Use of fluoride toothpaste during washout periods * Participation in another appliance study within the last 4 week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Surface Microhardness Recovery (%SMHR) | End of each 7-day test period (three periods total) | — |
| Enamel Fluoride Concentration (EFU) | End of each 7-day test period (three periods total) | Post-treatment enamel fluoride concentration (µg F/cm³) |
Countries
United States
Contacts
STUDY_DIRECTORAnnahita Ghassemi, PhD
Church & Dwight, Inc.
Outcome results
None listed