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

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.

Study Overview

• Status: Completed
• Conditions: Fluoridation
• Intervention / Treatment: Other: Meal

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 33 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 7, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: water; plaque; dental caries; salt; oral fluids
• Other Study ID Numbers: FOPBioq006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO