Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21

Universidad Autonoma de San Luis Potosí

Status and phase: Unknown; Phase 2

Conditions: Down Syndrome

Treatments: Drug: Fluor varnish; Drug: Fluor varnish with nanoparticles

Study type: Interventional

Funder types: Other

Identifiers

NCT01975545

MCIC-001

Details and patient eligibility

About

Patients with trisomy 21 are in greater danger of developing caries. It has been hypothesized that adding silver nanoparticles to fluor varnishes could promote remineralization of the teeth. A split-plot randomized controlled trial will be performed to address this question.

Enrollment: 20 estimated patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with trisomy 21 diagnosed through caryotype
• Age 1 to 6 years old
• Any sex
• White spot present in both upper anterior teeth
• Parental agreement to participate in the study

Exclusion criteria

• Hypersensibility to any of the substances used
• Non cooperating patients
• Caries in enamel or dentine in the upper anterior teeth
• Leukemia or diabetes
• Dental fluorosis present

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Fluor varnish

Active Comparator group

Description:

Fluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein)

Treatment:

Drug: Fluor varnish

Fluor varnish with nanoparticles

Experimental group

Description:

Fluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein) plus 25% 50 nm silver nanoparticles.

Treatment:

Drug: Fluor varnish with nanoparticles