Systemic Fluoride Bioavailability From Toothpastes Containing Calcium Carbonate or Silica as Abrasives

Phase 1

Completed

• Conditions: Dental Fluorosis
• Interventions: Drug: Fresh NaF/SiO2 toothpaste; Drug: Purified water; Drug: Aged NaF/SiO2 toothpaste; Drug: Fresh MFP/CaCO3 toothpaste; Drug: Aged MFP/CaCO3 toothpaste

• Registration Number: NCT01571050
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

The risk of dental fluorosis development is related to the systemic exposure to fluoride during enamel formation. Currently, diet and fluoride toothpastes are the main sources of fluoride to children at the age-risk for fluorosis development. However, when estimating the risk of fluorosis from toothpaste inadvertently ingested, it has not been considered the systemic fluoride bioavailability. Since some toothpaste formulations may contain part of fluoride as insoluble salts, the hypothesis behind this study is that only soluble fluoride in toothpastes would be absorbed when they are inadvertently ingested. To test that, adult volunteers will ingest a standardized dose of total fluoride from commercially available toothpastes, which present different concentrations of soluble fluoride. Fluoride systemic bioavailability will be assessed by the release of fluoride in saliva up to 3 hours after ingestion (as an indicator of blood fluoride) and by urinary fluoride excretion.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-08
• Study Completion: 2011-12
• Study First Submitted: 2012-03-30
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-02
• Last Update Submitted: 2012-04-02
• Study First Posted: 2012-04-04
• Last Update Posted: 2012-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Good general health
• Good oral health
• Normal salivary flow rate

Exclusion Criteria

• Gastric disorders
• Renal disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fresh NaF/SiO2 toothpaste	Fresh NaF/SiO2 toothpaste	-
Purified water	Purified water	-
Aged NaF/SiO2 toothpaste	Aged NaF/SiO2 toothpaste	-
Fresh MFP/CaCO3 toothpaste	Fresh MFP/CaCO3 toothpaste	-
Aged MFP/CaCO3 toothpaste	Aged MFP/CaCO3 toothpaste	-

Primary Outcome Measures

Name	Time	Method
Area under the curve of salivary fluoride concentration versus time after toothpaste ingestion	3 hours	Saliva will be collected before and up to 3 hours after ingestion of the toothpastes or negative control. Collections (during 3 min) will be made at 0 (immediately before ingestion), 15, 30, 45, 60, 120 and 180 min after ingestion.

Secondary Outcome Measures

Name	Time	Method
Maximum concentration of fluoride in saliva after toothpaste ingestion	3 hours	Saliva collected up to 3 hours after the ingestion of toothpastes or negative control will be analyzed for fluoride concentration and the maximum concentration during this period will be recorded.
Urinary fluoride excretion (24-h) after toothpaste ingestion	48 hours	Urine will be collected for the 24 hours preceeding the ingestion of the toothpastes or negative control and for the 24 hours after the ingestion. The difference in the amount of fluoride excreted in 24h urine samples, after or before the treatments, will be calculated.

Trial Locations

Locations (1)

Piracicaba Dental School, University of Campinas; 🇧🇷 Piracicaba, SP, Brazil