NCT01589458

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
Last Updated

May 2, 2012

Status Verified

April 1, 2012

Enrollment Period

6 months

First QC Date

April 29, 2012

Last Update Submit

May 1, 2012

Conditions

Dental Caries

Keywords

toothpastessalivadental cariesfluoride

Outcome Measures

Primary Outcomes (1)

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

    60 minutes

Secondary Outcomes (1)

  • Percentage of MFP hydrolyzed in saliva as a function of time

    60 minutes

Study Arms (3)

Non-fluoride toothpaste

PLACEBO COMPARATOR
Drug: Toothpaste

NaF/SiO2 toothpaste

EXPERIMENTAL
Drug: Toothpaste

MFP/CaCO3 toothpaste

EXPERIMENTAL
Drug: Toothpaste

Interventions

ToothpasteDRUG

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

MFP/CaCO3 toothpasteNaF/SiO2 toothpasteNon-fluoride toothpaste

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Use of systemic drugs that reduce salivary flow rate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piracicaba Dental School, University of Campinas

Piracicaba, São Paulo, 13414903, Brazil

Location

Related Publications (5)

  • Cury JA, Tenuta LM, Ribeiro CC, Paes Leme AF. The importance of fluoride dentifrices to the current dental caries prevalence in Brazil. Braz Dent J. 2004;15(3):167-74. doi: 10.1590/s0103-64402004000300001. Epub 2005 Mar 18.

    PMID: 15798817BACKGROUND

  • Ricomini Filho AP, Tenuta LM, Fernandes FS, Calvo AF, Kusano SC, Cury JA. Fluoride concentration in the top-selling Brazilian toothpastes purchased at different regions. Braz Dent J. 2012;23(1):45-8. doi: 10.1590/s0103-64402012000100008.

    PMID: 22460314BACKGROUND

  • 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: 21180793BACKGROUND

  • Tenuta LM, Cury JA. Fluoride: its role in dentistry. Braz Oral Res. 2010;24 Suppl 1:9-17. doi: 10.1590/s1806-83242010000500003.

    PMID: 20857070BACKGROUND

  • Carrera CA, Giacaman RA, Munoz-Sandoval C, Cury JA. Total and soluble fluoride content in commercial dentifrices in Chile. Acta Odontol Scand. 2012 Dec;70(6):583-8. doi: 10.3109/00016357.2011.640287. Epub 2011 Dec 20.

    PMID: 22182293BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Toothpastes

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

DentifricesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

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

April 29, 2012

First Posted

May 2, 2012

Study Start

August 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

May 2, 2012

Record last verified: 2012-04

Locations

BR(1)