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

NCT02776280 | Completed Phase 4

• 1 other identifier: FOPBioq006
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fluoridation

Keywords

water; salt; oral fluids; plaque; dental caries

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Negative control

PLACEBO COMPARATOR

Meal prepared with non-fluoridated water and salt

Other: Meal

Fluoridated water

EXPERIMENTAL

Meal prepared with fluoridated water

Other: Meal

Fluoridated salt

EXPERIMENTAL

Meal prepared with fluoridated salt

Other: Meal

Interventions

Meal OTHER

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

Fluoridated salt; Fluoridated water; Negative control

Eligibility Criteria

• Age: 18 Years - 33 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• good general health
• good oral health
• not having used topical fluorides in the last 2 months

You may not qualify if:

• poor general health
• poor oral health
• breastfeeding
• expecting mothers

Sponsors & Collaborators

• University of Campinas, Brazil: lead

MeSH Terms

Conditions

Plaque, Amyloid; Dental Caries

Interventions

Meals

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 18, 2016
• Study Start: July 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share