Fluoride Bioavailability After Ingestion of Water or Foods Prepared With Fluoridated Water

Phase 1

Completed

• Conditions: Dental Caries; Dental Fluorosis

• Registration Number: NCT01978041
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

The importance of fluoridated water to control caries is well recognized. Although the mode of action of fluoridated water is known (related to a slight increase in fluoride concentration in saliva/dental biofilm in individuals living in fluoridated areas), the kinetics of fluoride concentration in saliva after ingestion of food prepared with fluoridated water, either from fluoride remaining in the oral cavity after mastication, or from fluoride returning from salivary secretion is not known in details. Therefore, the aim of this study is to assess fluoride bioavailability after ingestion of food prepared with fluoridated water. The study will be in vivo, crossover and double blind, in which 12 adult volunteers will participate. In 4 experimental phases, volunteers will ingest: a. a typical Brazilian meal cooked with non-fluoridated water (\<0.1 ppm F); b. a typical Brazilian meal cooked with fluoridated water (1 ppm F); c. non fluoridated water (\<0.1 ppm F) and d. fluoridated water (1 ppm F). Immediately before and 5, 10, 15, 30, 45, 60, 120, 180 minutes after the ingestion, a blood sample will be collected by digital puncture, and a sample of unstimulated saliva will be collected. Fluoride concentration in the samples will be determined by an ion specific electrode adapted for microanalysis. Results will be analyzed by ANOVA, with significance limit of 5%.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-03
• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-31
• Study First Posted: 2013-11-07
• Study Completion: 2013-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Area under the curve of plasma fluoride concentration versus time after water or food ingestion	180 minutes	A microsample of blood will be collected by digital puncture before and 5, 10, 15, 30, 45, 60, 120 and 180 min after treatments, to calculate the area under the curve of fluoride concentration in the plasma

Secondary Outcome Measures

Name	Time	Method
Maximum fluoride concentration in saliva after water or food ingestion	180 minutes
Maximum fluoride concentration in plasma after water or food ingestion	180 minutes
Area under the curve of salivary fluoride concentration versus time after water or food ingestion	180 minutes	A sample of unstimulated saliva will be collected by digital puncture before and 5, 10, 15, 30, 45, 60, 120 and 180 min after treatments, to calculate the area under the curve of fluoride concentration in saliva

Trial Locations

Locations (1)

Piracicaba Dental School, University of Campinas; 🇧🇷 Piracicaba, São Paulo, Brazil