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

NCT01571050 | Completed Phase 1

• 1 other identifier: FOPFBioavailability2011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Fluorosis

Keywords

toothpastes; dental fluorosis; fluoride; bioavailability

Outcome Measures

Primary Outcomes (1)

• Area under the curve of salivary fluoride concentration versus time after toothpaste ingestion

  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.

  3 hours

Secondary Outcomes (2)

• Maximum concentration of fluoride in saliva after toothpaste ingestion

  3 hours

• Urinary fluoride excretion (24-h) after toothpaste ingestion

  48 hours

Study Arms (5)

Fresh NaF/SiO2 toothpaste

EXPERIMENTAL

Drug: Fresh NaF/SiO2 toothpaste

Purified water

PLACEBO COMPARATOR

Drug: Purified water

Aged NaF/SiO2 toothpaste

EXPERIMENTAL

Drug: Aged NaF/SiO2 toothpaste

Fresh MFP/CaCO3 toothpaste

EXPERIMENTAL

Drug: Fresh MFP/CaCO3 toothpaste

Aged MFP/CaCO3 toothpaste

EXPERIMENTAL

Drug: Aged MFP/CaCO3 toothpaste

Interventions

Purified water DRUG

Ingestion of 30 mL of purified water

Purified water

Fresh MFP/CaCO3 toothpaste DRUG

Ingestion of 31.9 mg of a fresh toothpaste containing 1450 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight.

Fresh MFP/CaCO3 toothpaste

Fresh NaF/SiO2 toothpaste DRUG

Ingestion of 49.5 mg of a fresh toothpaste containing 1100 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight.

Fresh NaF/SiO2 toothpaste

Aged NaF/SiO2 toothpaste DRUG

Ingestion of 49.5 mg of a toothpaste containing 1100 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight. The toothpaste had been previously aged to simulate one year storage at room temperature.

Aged NaF/SiO2 toothpaste

Aged MFP/CaCO3 toothpaste DRUG

Ingestion of 31.9 mg of a toothpaste containing 1450 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight. The toothpaste had been previously aged to simulate one year storage at room temperature.

Aged MFP/CaCO3 toothpaste

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Gastric disorders
• Renal disorders

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Piracicaba Dental School, University of Campinas

Piracicaba, São Paulo, 13414903, Brazil

Location

Related Publications (4)

• Cury JA, Del Fiol FS, Tenuta LM, Rosalen PL. Low-fluoride dentifrice and gastrointestinal fluoride absorption after meals. J Dent Res. 2005 Dec;84(12):1133-7. doi: 10.1177/154405910508401208.

  PMID: 16304442 BACKGROUND

• Cury JA, Oliveira MJ, Martins CC, Tenuta LM, Paiva SM. Available fluoride in toothpastes used by Brazilian children. Braz Dent J. 2010;21(5):396-400. doi: 10.1590/s0103-64402010000500003.

  PMID: 21180793 BACKGROUND

• Martins CC, Oliveira MJ, Pordeus IA, Cury JA, Paiva SM. Association between socioeconomic factors and the choice of dentifrice and fluoride intake by children. Int J Environ Res Public Health. 2011 Nov;8(11):4284-99. doi: 10.3390/ijerph8114284. Epub 2011 Nov 10.

  PMID: 22163207 BACKGROUND

• Falcao A, Tenuta LM, Cury JA. Fluoride gastrointestinal absorption from Na2FPO3/CaCO3- and NaF/SiO2-based toothpastes. Caries Res. 2013;47(3):226-33. doi: 10.1159/000346006. Epub 2012 Dec 29.

  PMID: 23295625 DERIVED

MeSH Terms

Conditions

Fluorosis, Dental

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Livia MA Tenuta, PhD

  Piracicaba Dental School, University of Campinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Biochemistry and Cariology

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 4, 2012
• Study Start: January 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 4, 2012

Record last verified: 2012-04

Locations

BR (1)