Oral Fluoride Bioavailability by the Consumption of Meals Prepared With Fluoridated Water or Salt

Study Overview
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Brief Summary
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This study will assess the concentration of fluoride in saliva and dental biofilm (fluid and solids) during and up to 2 hours after the consumption of typical Brazilian meals prepared with fluoridated water (0.7 ppm F) or fluoridated salt (250 mg F/kg). Typical Brazilian meals (rice, beans, meat with vegetables) will be prepared using fluoridated water, salt, or non-fluoridated water and salt. In an crossover design, twelve volunteers will eat 4.67 g of food/kg body weight of each meal, on fasting, during 15 min. Before the ingestion, unstimulated saliva and dental biofilm will be collected for determination of fluoride concentration. During the meal, 3 samples of the alimentary bolus (at 5, 10 and 15 min of mastication) will be collected for determination of fluoride concentration. Dental biofilm will be collected immediately after the ingestion of the meal. Saliva will then be collected after 5, 10, 15, 30, 60 and 120 min. All samples will be analyzed for fluoride using an ion-specific electrode. In order to standardize biofilm formation, during lead-in and wash-out periods, volunteers will: 1. brush their teeth with non-fluoride toothpaste; 2. refrain from brushing superior posterior teeth for 2 days before each phase; and 3. chew sucrose-containing chewing gum 5 times/day, for 10 min, during the 2 days prior to each phase. Groups will be compared by ANOVA and Tukey test.

Conditions
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Fluoridation

Intervention / Treatment
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* Other: Meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: good general health good oral health not having used topical fluorides in the last 2 months Exclusion Criteria: poor general health poor oral health breastfeeding expecting mothers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 33 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Negative control<br>Meal prepared with non-fluoridated water and salt | Other: Meal<br>* Typical Brazilian meal consisting of rice, beans and meat with vegetables<br>|
| Experimental: Fluoridated water<br>Meal prepared with fluoridated water | Other: Meal<br>* Typical Brazilian meal consisting of rice, beans and meat with vegetables<br>|
| Experimental: Fluoridated salt<br>Meal prepared with fluoridated salt | Other: Meal<br>* Typical Brazilian meal consisting of rice, beans and meat with vegetables<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoride concentration in the alimentary bolus |  | up to 15 min after start of the meal | 
| Fluoride concentration in saliva |  | up to 120 min after meal | 
| Fluoride concentration in dental biofilm |  | up to 120 min after the meal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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water, salt, oral fluids, plaque, dental caries