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

NCT01975545 | Unknown Phase 2

• 1 other identifier: MCIC-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Keywords

Down syndrome; Caries; Dental varnish

Outcome Measures

Primary Outcomes (1)

• Remineralization

  Remineralization status will be assessed through laser fluorescence of the tooth with a Diagnodent probe (Diagnodent, Kavo, Madrid, Spain)

  3 months

Study Arms (2)

Fluor varnish

ACTIVE COMPARATOR

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

Drug: Fluor varnish

Fluor varnish with nanoparticles

EXPERIMENTAL

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

Drug: Fluor varnish with nanoparticles

Interventions

Fluor varnish DRUG

Dental varnish will be applied to one anterior superior teeth in a random side.

Also known as: Fluor dental varnish

Fluor varnish

Fluor varnish with nanoparticles DRUG

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

Also known as: Fluor dental varnish with silver nanoparticles.

Fluor varnish with nanoparticles

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de San Luis Potosí: lead

Study Sites (1)

Universidad Autónoma de San Luis Potosí

San Luis Potosí City, San Luis Potosí, 78210, Mexico

Location

MeSH Terms

Conditions

Down Syndrome

Interventions

Nanoparticles; colloidal silver

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Nanostructures; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mauricio Pierdant-Pérez, Md, MSc

  Universidad Autonoma de San Luis Potosí

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Claudia Butrón-TéllezGiron, Dent.

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: November 4, 2013
• Study Start: September 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

ME (1)