Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

Study Overview
=================
Brief Summary
-----------------
Fluoride toothpaste has been associated not only with declining dental caries prevalence but also with an increase in dental fluorosis. In the balance of benefits/risks of fluoride toothpaste use, the purpose of this study is to evaluate the availability of fluoride concentration in the mouth (biofilm fuild), as an indicator of fluoride benefits (anticaries effect), and the fluoride concentration in urine, as an indicator of fluoride absorption from ingested toothpastes (with potential to cause dental fluorosis), in a sample of young Brazilian children using toothpaste formulations representative of those available and most used by this age-group.

Official Title
-----------------
Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

Conditions
-----------------
Dental Caries, Dental Fluorosis

Intervention / Treatment
-----------------
* Drug: Toothpaste


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good general health Good oral health

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 4 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 |
| --- | --- |
| Placebo Comparator: Non-fluoride toothpaste<br> | Drug: Toothpaste<br>* The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.<br>|
| Experimental: Toothpaste 550 µg F/g (NaF/SiO2)<br> | Drug: Toothpaste<br>* The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.<br>|
| Experimental: Toothpaste 1100 µg F/g (NaF/SiO2)<br> | Drug: Toothpaste<br>* The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.<br>|
| Experimental: Toothpaste 1450 µg F/g (MFP/CaCO3)<br> | Drug: Toothpaste<br>* The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoride concentration in biofilm fluid | Remants of dental plaque (biofilm) will be collected 30 min after brushing with the toothpastes, the fluid will be separated from the solids by centrifugation and the fluoride concentration in the biofilm fluid will be determined by a fluoride electrode adapted for microanalysis. | 30min | 
| Urinary fluoride excretion | Urine will be collected at two time-points, either before the use of the toothpaste or at the last day of use, in each experimental phase. Fluoride concentration was determined by an inverted ion-specific fluoride electrode and fluoride excretion will be measured by fluoride/cratinine ratio (mg F/mg creatinine). | 8h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoride concentration in biofilm solid | Remants of dental plaque (biofilm) will be collected 30 min after brushing with the toothpastes, the fluid will be separated from the solids by centrifugation and the fluoride concentration in the biofilm solids will be determined after acid extraction using a fluoride electrode adapted for microanalysis. | 30min | 
| Fluoride concentration in saliva | Non-stimulated saliva will be collected at 0 (immediately before toothbrushing), 7, 15 and 30 min after toothbrushing. Fluoride concentration in saliva will be determined by a ion-specific fluoride electrode, adapted for microanalysis. | 30min | 
| Amount of toothpaste ingested | Determination of amount of toothpaste ingested after one simulated brushing. | January 2013 to July 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
toothpastes, bioavailability, sodium fluoride, monofluorphosphate, low-fluoride