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NCT01975545 Clinical Trial

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

Down Syndrome Clinical Trial

Official title:
Efficacy of the Addition of Silver Nanoparticles to a Fluor Varnish in the Remineralization of Temporary Teeth in Patients With Trisomy 21. Randomized Clinical Trial.

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01975545
Other study ID # MCIC-001
Secondary ID
Status Unknown status
Phase Phase 2
First received September 3, 2013
Last updated March 5, 2014
Start date September 2012
Est. completion date May 2014

Study information
Verified date March 2014
Source Universidad Autonoma de San Luis Potosí
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 20
Est. completion date May 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 1 Year to 6 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fluor varnish
Dental varnish will be applied to one anterior superior teeth in a random side.
• Fluor varnish with nanoparticles
Dental varnish with silver nanoparticles will be applied to one anterior superior teeth in a random side.

Locations
Country Name City State
Mexico Universidad Autónoma de San Luis Potosí San Luis Potosí

Sponsors (1)
Lead Sponsor Collaborator
Universidad Autonoma de San Luis Potosí

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Remineralization Remineralization status will be assessed through laser fluorescence of the tooth with a Diagnodent probe (Diagnodent, Kavo, Madrid, Spain) 3 months
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