Fluoride Bioavailability in Plasma and Saliva After Ingestion of Water or Foods Prepared With Fluoridated Water
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
Livia Maria Andaló Tenuta
Associate Professor, Biochemistry and Cariology
University of Campinas, Brazil
