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

University of Campinas, Brazil

Status and phase: Completed; Phase 1

Conditions: Dental Fluorosis

Treatments: Drug: Fresh NaF/SiO2 toothpaste; Drug: Aged MFP/CaCO3 toothpaste; Drug: Fresh MFP/CaCO3 toothpaste; Drug: Aged NaF/SiO2 toothpaste; Drug: Purified water

Study type: Interventional

Funder types: Other

Identifiers

NCT01571050

FOPFBioavailability2011

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Gastric disorders
• Renal disorders

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

20 participants in 5 patient groups, including a placebo group

Fresh NaF/SiO2 toothpaste

Experimental group

Treatment:

Drug: Fresh NaF/SiO2 toothpaste

Purified water

Placebo Comparator group

Treatment:

Drug: Purified water

Aged NaF/SiO2 toothpaste

Experimental group

Treatment:

Drug: Aged NaF/SiO2 toothpaste

Fresh MFP/CaCO3 toothpaste

Experimental group

Treatment:

Drug: Fresh MFP/CaCO3 toothpaste

Aged MFP/CaCO3 toothpaste

Experimental group

Treatment:

Drug: Aged MFP/CaCO3 toothpaste