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OpenTrials
Completed

NCT Number: NCT01589458

Fluoride Availability in Saliva After Use of Sodium Fluoride or Monofluorophosphate Toothpastes

Considering the widespread use of sodium fluoride (NaF) and monofluorophosphate (MFP) based toothpastes, the present study aim to evaluate F availability in saliva after use of the top-selling Brazilian toothpastes. In a blind, crossover clinical trial study, volunteers will brush their teeth with one of the following toothpastes: 1) non-fluoride toothpaste (negative control group); 2) NaF/silica based toothpaste 3)MFP/calcium carbonate based toothpaste. After brushing, a rinse with purified water will be performed. Unstimulated saliva will be collected before and up to 60 min after brushing. Ionic fluoride and total soluble fluoride (corresponding to the sum of fluoride as ion and as MFP) will be determined after acid treatment of salivary samples to hydrolyze MFP. Fluoride will be determined using an ion selective electrode.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Piracicaba Dental School, University of Campinas

Piracicaba, São Paulo, 13414903, Brazil

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
  • Normal salivary flow rate

Exclusion criteria

  • Use of systemic drugs that reduce salivary flow rate

Treatment and study plan

Toothpaste

Drug

1-min brushing with 1 g of the assigned toothpaste followed by a 10 mL purified water rinse

Primary outcomes

  1. Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes

    Time frame: 60 minutes

Secondary outcomes

  1. Percentage of MFP hydrolyzed in saliva as a function of time

    Time frame: 60 minutes

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

Fluoride Availability in Saliva After Use of NaF or MFP Toothpastes

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 2, 2012
Registry last updated
May 2, 2012

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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