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OpenTrials
Completed

NCT Number: NCT02776280

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal

Other

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

Primary outcomes

  1. Fluoride concentration in the alimentary bolus

    Time frame: up to 15 min after start of the meal

  2. Fluoride concentration in saliva

    Time frame: up to 120 min after meal

  3. Fluoride concentration in dental biofilm

    Time frame: up to 120 min after the meal

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 18, 2016
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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