Skip to content

Fluoride soluble in artificial gastric juice as an indicator of systemic bioavailability of toothpastes

Fluoride soluble in HCl 0.01 N found in MFP/CaCO3 - based toothpaste as indicator of fluoride systemically bioavailable

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8tkmr7
Enrollment
Unknown
Registered
2020-06-01
Start date
2019-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental fluorosis

Interventions

Participants will be submitted to four treatment groups: group I- Fresh dentifrice with 1332.5 ppm of fluoride (F), group II to IV: aged dentifrice having 1113.5, 796.6 and 667.4 ppm of F, respectivel
Other

Sponsors

Faculdade de Odontologia de Piracicaba
Lead Sponsor
Faculdade de Odontologia de Piracicaba
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: participants in good general health; participants with normal salivary flow (unstimulated saliva equal to or greater than 0.3 to 0.4 mL per min)

Exclusion criteria

Exclusion criteria: participants with kidney disease; participants with gastrointestinal disease

Design outcomes

Primary

MeasureTime frame
The concentration of fluoride in the blood plasma is expected to be proportional to the amount of total soluble fluoride ingested. The fluoride concentration in the plasma will be analyzed with the aid of the specific ion electrode, and the calculation of the area under the curve will be performed. Blood samples will be collected at 0 min (before ingestion) and for 180 min after ingestion.;The concentration of fluoride in saliva is expected to be proportional to the amount of total soluble fluoride ingested. The concentration of fluoride in the saliva will be analyzed with the aid of the specific ion electrode, and the calculation of the area under the curve will be performed. Saliva samples will be collected at 0 min (before ingestion) and for 180 min after ingestion.;The amount of F excreted in the urine is expected to be proportional to the amount of total soluble fluoride ingested. Urine samples will be collected 24 hours before ingesting the suspension and 24 hours afterwards. The concentration of F in the urine will be assessed with a specific fluoride ion electrode. The value of the fluoride concentration in the urine found will be multiplied by the total volume collected to determine the amount of fluoride excreted.

Secondary

MeasureTime frame
Are not expected secondary outcomes

Countries

Brazil

Contacts

Public ContactDeborah da Rocha

Faculdade de Odontologia de Piracicaba

deborahrackel@gmail.com+55-019-21065303

Outcome results

None listed

Source: REBEC (via WHO ICTRP)