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

University of Campinas, Brazil

Status and phase: Completed; Phase 1

Conditions: Dental Fluorosis; Dental Caries

Treatments: Other: Non fluoridated water; Other: Meal prepared to provide a fluoride dose of 60 ug F/kg; Other: Meal prepared to provide a fluoride dose of 120 ug F/kg; Other: Meal prepared with non fluoridated water; Other: Fluoridated water; Other: Meal prepared with fluoridated water

Study type: Interventional

Funder types: Other

Identifiers

NCT01978041

FOPBioq004

Details and patient eligibility

About

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%.

Enrollment: 20 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 6 patient groups

Meal prepared with non fluoridated water (<0.1 ppm F)

Experimental group

Treatment:

Other: Meal prepared with non fluoridated water

Meal prepared with fluoridated water (1 ppm F)

Experimental group

Treatment:

Other: Meal prepared with fluoridated water

Non fluoridated water (<0.1 ppm F)

Experimental group

Treatment:

Other: Non fluoridated water

Fluoridated water (1 ppm F)

Experimental group

Treatment:

Other: Fluoridated water

Pilot study: Meal providing a fluoride dose of 60 ug F/kg

Experimental group

Treatment:

Other: Meal prepared to provide a fluoride dose of 60 ug F/kg

Pilot study: Meal providing a fluoride dose of 120 ug F/kg

Experimental group

Treatment:

Other: Meal prepared to provide a fluoride dose of 120 ug F/kg