Overview

This trial is active, not recruiting.

Condition fluoridation
Treatment meal
Phase phase 4
Sponsor University of Campinas, Brazil
Collaborator Carolina Veloso Lima
Start date July 2015
End date May 2016
Trial size 12 participants
Trial identifier NCT02776280, FOPBioq006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Placebo Comparator)
Meal prepared with non-fluoridated water and salt
meal
Typical Brazilian meal consisting of rice, beans and meat with vegetables
(Experimental)
Meal prepared with fluoridated water
meal
Typical Brazilian meal consisting of rice, beans and meat with vegetables
(Experimental)
Meal prepared with fluoridated salt
meal
Typical Brazilian meal consisting of rice, beans and meat with vegetables

Primary Outcomes

Measure
Fluoride concentration in the alimentary bolus
time frame: up to 15 min after start of the meal
Fluoride concentration in saliva
time frame: up to 120 min after meal
Fluoride concentration in dental biofilm
time frame: up to 120 min after the meal

Eligibility Criteria

Male or female participants from 18 years up to 33 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Campinas, Brazil.