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

Phase 4

Completed

• Conditions: Fluoridation
• Interventions: Other: Meal

• Registration Number: NCT02776280
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2016-05
• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-18
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-07
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Negative control	Meal	Meal prepared with non-fluoridated water and salt
Fluoridated water	Meal	Meal prepared with fluoridated water
Fluoridated salt	Meal	Meal prepared with fluoridated salt

Primary Outcome Measures

Name	Time	Method
Fluoride concentration in saliva	up to 120 min after meal
Fluoride concentration in dental biofilm	up to 120 min after the meal
Fluoride concentration in the alimentary bolus	up to 15 min after start of the meal