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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02776280
Enrollment
12
Registered
2016-05-18
Start date
2015-07-31
Completion date
2016-12-31
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluoridation

Keywords

water, salt, oral fluids, plaque, dental caries

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.

Interventions

OTHERMeal

Typical Brazilian meal consisting of rice, beans and meat with vegetables

Sponsors

University of Campinas, Brazil
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 33 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Fluoride concentration in the alimentary bolusup to 15 min after start of the meal
Fluoride concentration in salivaup to 120 min after meal
Fluoride concentration in dental biofilmup to 120 min after the meal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026