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

Primary Purpose

Down Syndrome

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Fluor varnish
Fluor varnish with nanoparticles
Sponsored by
Universidad Autonoma de San Luis Potosí
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Down Syndrome focused on measuring Down syndrome, Caries, Dental varnish

Eligibility Criteria

1 Year - 6 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Universidad Autónoma de San Luis Potosí

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fluor varnish

Fluor varnish with nanoparticles

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 3, 2013
Last Updated
March 5, 2014
Sponsor
Universidad Autonoma de San Luis Potosí
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1. Study Identification

Unique Protocol Identification Number
NCT01975545
Brief Title
Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21
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 Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de San Luis Potosí

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Down syndrome, Caries, Dental varnish

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluor varnish
Arm Type
Active Comparator
Arm Description
Fluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein)
Arm Title
Fluor varnish with nanoparticles
Arm Type
Experimental
Arm Description
Fluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein) plus 25% 50 nm silver nanoparticles.
Intervention Type
Drug
Intervention Name(s)
Fluor varnish
Other Intervention Name(s)
Fluor dental varnish
Intervention Description
Dental varnish will be applied to one anterior superior teeth in a random side.
Intervention Type
Drug
Intervention Name(s)
Fluor varnish with nanoparticles
Other Intervention Name(s)
Fluor dental varnish with silver nanoparticles.
Intervention Description
Dental varnish with silver nanoparticles will be applied to one anterior superior teeth in a random side.
Primary Outcome Measure Information:
Title
Remineralization
Description
Remineralization status will be assessed through laser fluorescence of the tooth with a Diagnodent probe (Diagnodent, Kavo, Madrid, Spain)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricio Pierdant-Pérez, Md, MSc
Organizational Affiliation
Universidad Autónoma de San Luis Potosí
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Autónoma de San Luis Potosí
City
San Luis Potosí
ZIP/Postal Code
78210
Country
Mexico

12. IPD Sharing Statement

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

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