Fluoride Availability in Saliva After Use of Sodium Fluoride or Monofluorophosphate Toothpastes
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Caries |
Drug: Toothpaste |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | Fluoride Availability in Saliva After Use of NaF or MFP Toothpastes |
- Area under the curve of salivary fluoride concentration versus time after brushing with fluoride toothpastes [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
- Percentage of MFP hydrolyzed in saliva as a function of time [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | August 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Non-fluoride toothpaste |
Drug: Toothpaste
1-min brushing with 1 g of the assigned toothpaste followed by a 10 mL purified water rinse
|
| Experimental: NaF/SiO2 toothpaste |
Drug: Toothpaste
1-min brushing with 1 g of the assigned toothpaste followed by a 10 mL purified water rinse
|
| Experimental: MFP/CaCO3 toothpaste |
Drug: Toothpaste
1-min brushing with 1 g of the assigned toothpaste followed by a 10 mL purified water rinse
|
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Good general health
- Good oral health
- Normal salivary flow rate
Exclusion Criteria:
- Use of systemic drugs that reduce salivary flow rate
Contacts and Locations| Brazil | |
| Piracicaba Dental School, University of Campinas | |
| Piracicaba, São Paulo, Brazil, 13414903 | |
| Principal Investigator: | Livia MA Tenuta, PhD | Piracicaba Dental School, University of Campinas |
More Information
Additional Information:
Publications:
| Responsible Party: | Livia Maria Andaló Tenuta, Assistant Professor, Biochemistry and Cariology, University of Campinas, Brazil |
| ClinicalTrials.gov Identifier: | NCT01589458 History of Changes |
| Other Study ID Numbers: | FOPBioq003 |
| Study First Received: | April 29, 2012 |
| Last Updated: | May 1, 2012 |
| Health Authority: | Brazil: Ministry of Health |
Keywords provided by University of Campinas, Brazil:
|
toothpastes saliva dental caries fluoride |
Additional relevant MeSH terms:
|
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases Fluorides |
Cariostatic Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013