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Effect of Fluoride Varnish with Phosphate on Dental Caries

Effect of Fluoride Varnish containing Sodium Trimetaphosphate on the progression of Dental Caries in vivo: randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5x5k45
Enrollment
Unknown
Registered
2017-10-30
Start date
2016-02-18
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

Problem being prevented or tracked is tooth decay. Dental Caries

Interventions

Experimental group: 130 children of 3-5 years in the fluoride varnish group
130 children 3-5 years in the group of fluoride varnish plus phosphate
130 children aged 3-5 years in the placebo varnish group. 200 adolescents aged 11-15 years in the fluoride varnish group
200 adolescents aged 11-15 years in the fluoride varnish plus phosphate group
200 adolescents aged 11-15 years in the placebo varnish group. Toothbones and toothbrushes were provided to the volunteers. Each volunteer used only one varnish, no split mouth.
Other
N02.421.044

Sponsors

Faculdade de Odontologia de Araçatuba - UNESP
Lead Sponsor
Faculdade de Odontologia de Araçatuba - UNESP
Collaborator

Eligibility

Age
3 Years to 15 Years

Inclusion criteria

Inclusion criteria: Volunteers must be aged between 3 to 5 years and 11 to 15 years; must agree to participate in the study through free and informed consent signed by parents or guardians; good general health status; did not participate in any other clinical study in the 3 months prior to selection; do not use any other vehicle with fluoride that is not provided by the study investigators.

Exclusion criteria

Exclusion criteria: Voluntary withdrawal; use of mouthwash or toothpaste not provided by the researchers; failure to comply with the clinical protocol.

Design outcomes

Primary

MeasureTime frame
The group of fluoride varnish containing phosphate will have the lowest number of decayed teeth compared to the other groups at the end of the study. The data will be submitted ANOVA statistical analysis, followed by the Tukey or Student-Newman-Keuls test.

Secondary

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactMichele Manarelli

Faculdade de Odontologia de Araçatuba - UNESP

michelemanarelli@gmail.com55-95-981039876

Outcome results

None listed

Source: REBEC (via WHO ICTRP)