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

University of Campinas, Brazil

Status and phase: Completed; Phase 1

Conditions: Dental Caries

Treatments: Drug: Toothpaste

Study type: Interventional

Funder types: Other

Identifiers

NCT01589458

FOPBioq003

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Use of systemic drugs that reduce salivary flow rate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 3 patient groups, including a placebo group

Non-fluoride toothpaste

Placebo Comparator group

Treatment:

Drug: Toothpaste

NaF/SiO2 toothpaste

Experimental group

Treatment:

Drug: Toothpaste

MFP/CaCO3 toothpaste

Experimental group

Treatment:

Drug: Toothpaste