Fluoride in Saliva After Use of Fluoride Toothpastes Followed by Fluoride Mouthrinses

Study Overview
=================
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.

Official Title
-----------------
Fluoride Bioavailability in Saliva After Use of Prescription and Over-the-counter Toothpastes Followed by Fluoride Mouthrinses

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Drug: Crest Cavity Protection toothpaste
* Drug: Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse
* Drug: Colgate PreviDent 5000+ toothpaste
* Drug: Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Crest Cavity Protection<br>Crest Cavity Protection toothpaste (1,100 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water | Drug: Crest Cavity Protection toothpaste<br>* 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<br>* Other names: Over-the-counter fluoride toothpaste followed by water rinse;|
| Active Comparator: Crest Cavity Protection followed by Act Mint Fluoride Rinse<br>Crest Cavity Protection toothpaste (1,100 ppm F) will be used to brush teeth, followed by a mouth rinse with Act Mint Fluoride Rinse (226 ppm) | Drug: Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse<br>* 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<br>* Other names: Over-the-counter fluoride toothpaste followed by fluoride rinse;|
| Active Comparator: Colgate PreviDent 5000+<br>Colgate PreviDent 5000+ (5,000 ppm F) will be used to brush teeth, followed by a mouth rinse with tap water | Drug: Colgate PreviDent 5000+ toothpaste<br>* 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<br>* Other names: Prescription fluoride toothpaste followed by water rinse;|
| Experimental: Colgate PreviDent 5000+ followed by Act Mint Fluoride Rinse<br>Colgate PreviDent 5000+ (5,000 ppm F) will be used to brush teeth, followed by a mouth rinse with Act Mint Fluoride Rinse (226 ppm) | Drug: Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse<br>* 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<br>* Other names: Prescription fluoride toothpaste followed by fluoride rinse;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of fluoride bioavailability in saliva | 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 | 0 to 60 minutes after the interventions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum fluoride concentration in saliva | From the area under the curve, the time at which the concentration in saliva is highest will be determined | 0 to 60 minutes after the interventions |