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

Primary Purpose

Dental Fluorosis

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Purified water
Fresh MFP/CaCO3 toothpaste
Fresh NaF/SiO2 toothpaste
Aged NaF/SiO2 toothpaste
Aged MFP/CaCO3 toothpaste
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Fluorosis focused on measuring toothpastes, dental fluorosis, fluoride, bioavailability

Eligibility Criteria

19 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Gastric disorders
  • Renal disorders

Sites / Locations

  • Piracicaba Dental School, University of Campinas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Fresh NaF/SiO2 toothpaste

Purified water

Aged NaF/SiO2 toothpaste

Fresh MFP/CaCO3 toothpaste

Aged MFP/CaCO3 toothpaste

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximum concentration of fluoride in saliva after toothpaste ingestion
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
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.

Full Information

First Posted
March 30, 2012
Last Updated
April 2, 2012
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01571050
Brief Title
Systemic Fluoride Bioavailability From Toothpastes Containing Calcium Carbonate or Silica as Abrasives
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Fluorosis
Keywords
toothpastes, dental fluorosis, fluoride, bioavailability

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fresh NaF/SiO2 toothpaste
Arm Type
Experimental
Arm Title
Purified water
Arm Type
Placebo Comparator
Arm Title
Aged NaF/SiO2 toothpaste
Arm Type
Experimental
Arm Title
Fresh MFP/CaCO3 toothpaste
Arm Type
Experimental
Arm Title
Aged MFP/CaCO3 toothpaste
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Purified water
Intervention Description
Ingestion of 30 mL of purified water
Intervention Type
Drug
Intervention Name(s)
Fresh MFP/CaCO3 toothpaste
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fresh NaF/SiO2 toothpaste
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Aged NaF/SiO2 toothpaste
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Aged MFP/CaCO3 toothpaste
Intervention Description
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.
Primary Outcome Measure Information:
Title
Area under the curve of salivary fluoride concentration versus time after toothpaste ingestion
Description
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.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Maximum concentration of fluoride in saliva after toothpaste ingestion
Description
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.
Time Frame
3 hours
Title
Urinary fluoride excretion (24-h) after toothpaste ingestion
Description
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.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Good general health Good oral health Normal salivary flow rate Exclusion Criteria: Gastric disorders Renal disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Livia MA Tenuta, PhD
Organizational Affiliation
Piracicaba Dental School, University of Campinas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piracicaba Dental School, University of Campinas
City
Piracicaba
State/Province
SP
ZIP/Postal Code
13414903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
16304442
Citation
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.
Results Reference
background
PubMed Identifier
21180793
Citation
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.
Results Reference
background
PubMed Identifier
22163207
Citation
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.
Results Reference
background
PubMed Identifier
23295625
Citation
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.
Results Reference
derived

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

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