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

Sponsor

University of Campinas, Brazil (Other)

Overall Status

Completed

CT.gov ID

NCT02776280

Collaborator

(none)

Enrollment

Arms

17.1

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fluoridation	Other: Meal	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Negative control Meal prepared with non-fluoridated water and salt	Other: Meal Typical Brazilian meal consisting of rice, beans and meat with vegetables
Experimental: Fluoridated water Meal prepared with fluoridated water	Other: Meal Typical Brazilian meal consisting of rice, beans and meat with vegetables
Experimental: Fluoridated salt Meal prepared with fluoridated salt	Other: Meal Typical Brazilian meal consisting of rice, beans and meat with vegetables

Arm

Intervention/Treatment

Placebo Comparator: Negative control

Meal prepared with non-fluoridated water and salt

Other: Meal

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

Experimental: Fluoridated water

Meal prepared with fluoridated water

Other: Meal

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

Experimental: Fluoridated salt

Meal prepared with fluoridated salt

Other: Meal

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

Outcome Measures

Primary Outcome Measures

Fluoride concentration in the alimentary bolus [up to 15 min after start of the meal]
Fluoride concentration in saliva [up to 120 min after meal]
Fluoride concentration in dental biofilm [up to 120 min after the meal]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 33 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Campinas, Brazil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Livia Maria Andaló Tenuta, Associate Professor, University of Campinas, Brazil

ClinicalTrials.gov Identifier:

NCT02776280

Other Study ID Numbers:

FOPBioq006

First Posted:

May 18, 2016

Last Update Posted:

May 9, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Livia Maria Andaló Tenuta, Associate Professor, University of Campinas, Brazil

Study Results

No Results Posted as of May 9, 2017