Dental Caries
Conditions
Brief summary
This study will evaluate fluoride (F) bioavailability in saliva when using an over-the-counter mouthrinse of 226 ppm F, immediately after brushing with an over-the-counter toothpaste of 1,100 ppm F or a prescription toothpaste of 5,000 ppm F. The study population will include twenty individuals, over the age of 18 years-old, from both genders, with normal oral health conditions and salivary flow rate, no need of urgent dental needs, from the Ann Arbor, MI area. Participants will be recruited from the University of Michigan School of Dentistry, in Ann Arbor, MI. Using a crossover design, twenty participants will be rotating through 4 different combinations of fluoride toothpaste (over-the-counter or prescription concentration) and fluoride mouth rinse (yes or no), in a 2 x 2 factorial design. Treatments to be tested will be as followed: Group #1 will brush with 1,100 ppm F (over-the-counter) toothpaste; Group #2 will brush with 1,100 ppm F (over-the-counter) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse; Group #3 will brush with 5,000 ppm F (prescription) toothpaste; Group #4 will brush with 5,000 ppm F (prescription) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse.
Interventions
Participants will brush their teeth with Crest Cavity Protection toothpaste (1,100 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of tap water for 10 seconds
DRUGCrest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse
Participants will brush their teeth with Crest Cavity Protection toothpaste (1,100 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of Act Mint Fluoride Rinse (226 ppm) for 1 minute
DRUGColgate PreviDent 5000+ toothpaste
Participants will brush their teeth with Colgate PreviDent 5000+ (5,000 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of tap water for 10 seconds
DRUGColgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse
Participants will brush their teeth with Colgate PreviDent 5000+ (5,000 ppm F) for 1 minute, expectorate the foam, and rinse their mouths with 10 mL of Act Mint Fluoride Rinse (226 ppm) for 1 minute
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Sign informed consent form * Participant understands and agrees to comply with the study protocol, and confirms availability for the entire duration of the study * 18 years of age or older * Good general health * Good oral health, with no urgent treatment needs * Normal salivary flow rate
Exclusion criteria
* Fail to understand or to agree to follow the study protocol * Reduced salivary flow rate * Poor general or oral health conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve of fluoride bioavailability in saliva | 0 to 60 minutes after the interventions | Fluoride concentration in saliva will be measured before (baseline) and up to 60 min after the interventions, and the area under the curve of fluoride concentration versus time will be calculated to estimate bioavailability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum fluoride concentration in saliva | 0 to 60 minutes after the interventions | From the area under the curve, the time at which the concentration in saliva is highest will be determined |
Countries
United States
Outcome results
None listed