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Clinical Trials/NCT01978041
NCT01978041CompletedPhase 1

Fluoride Bioavailability in Plasma and Saliva After Ingestion of Water or Foods Prepared With Fluoridated Water

University of Campinas, Brazil2 sites in 1 country20 target enrollmentStarted: January 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
20
Locations
2
Primary Endpoint
Area under the curve of plasma fluoride concentration versus time after water or food ingestion

Study Overview

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%.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Good general health
  • Good oral health
  • Normal salivary flow rate

Exclusion Criteria

  • Gastric disorders
  • Renal disorders
  • Systemic diseases
  • Use of drugs that alter salivary flow rate/renal excretion

Outcomes

Primary Outcomes

Area under the curve of plasma fluoride concentration versus time after water or food ingestion

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor
University of Campinas, Brazil
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Livia Maria Andaló Tenuta

Associate Professor, Biochemistry and Cariology

University of Campinas, Brazil

Study Sites (2)

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