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

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ClinicalTrials.gov Identifier: NCT01975545
Recruitment Status : Unknown
Verified March 2014 by Claudia Butrón Téllez Girón, Universidad Autonoma de San Luis Potosí.
Recruitment status was:  Active, not recruiting
First Posted : November 4, 2013
Last Update Posted : March 7, 2014
Sponsor:
Information provided by (Responsible Party):
Claudia Butrón Téllez Girón, Universidad Autonoma de San Luis Potosí

Brief 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.

Condition or disease Intervention/treatment Phase
Down Syndrome Drug: Fluor varnish Drug: Fluor varnish with nanoparticles Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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.
Study Start Date : September 2012
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Arm Intervention/treatment
Active Comparator: Fluor varnish
Fluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein)
Drug: Fluor varnish
Dental varnish will be applied to one anterior superior teeth in a random side.
Other Name: Fluor dental varnish

Experimental: Fluor varnish with nanoparticles
Fluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein) plus 25% 50 nm silver nanoparticles.
Drug: Fluor varnish with nanoparticles
Dental varnish with silver nanoparticles will be applied to one anterior superior teeth in a random side.
Other Name: Fluor dental varnish with silver nanoparticles.




Primary Outcome Measures :
  1. Remineralization [ Time Frame: 3 months ]
    Remineralization status will be assessed through laser fluorescence of the tooth with a Diagnodent probe (Diagnodent, Kavo, Madrid, Spain)



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975545


Locations
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Mexico
Universidad Autónoma de San Luis Potosí
San Luis Potosí, Mexico, 78210
Sponsors and Collaborators
Universidad Autonoma de San Luis Potosí
Investigators
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Study Director: Mauricio Pierdant-Pérez, Md, MSc Universidad Autónoma de San Luis Potosí

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Responsible Party: Claudia Butrón Téllez Girón, Claudia Butrón-TéllezGiron, Dent., Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier: NCT01975545     History of Changes
Other Study ID Numbers: MCIC-001
First Posted: November 4, 2013    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: March 2014

Keywords provided by Claudia Butrón Téllez Girón, Universidad Autonoma de San Luis Potosí:
Down syndrome
Caries
Dental varnish

Additional relevant MeSH terms:
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Down Syndrome
Trisomy
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Aneuploidy
Chromosome Aberrations
Pathologic Processes
Chromosome Duplication