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

March 5, 2014 updated by: Claudia Butrón Téllez Girón, Universidad Autonoma de San Luis Potosí

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • San Luis Potosí, Mexico, 78210
        • Universidad Autonoma de San Luis Potosí

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Fluor dental varnish with silver nanoparticles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remineralization
Time Frame: 3 months
Remineralization status will be assessed through laser fluorescence of the tooth with a Diagnodent probe (Diagnodent, Kavo, Madrid, Spain)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de San Luis Potosí

Investigators

  • Study Director: Mauricio Pierdant-Pérez, Md, MSc, Universidad Autonoma de San Luis Potosí

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ANTICIPATED)

April 1, 2014

Study Completion (ANTICIPATED)

May 1, 2014

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (ESTIMATE)

November 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 7, 2014

Last Update Submitted That Met QC Criteria

March 5, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCIC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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