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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 3, 2013
First Posted Date  ICMJE November 4, 2013
Last Update Posted Date March 7, 2014
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
Remineralization [ Time Frame: 3 months ]
Remineralization status will be assessed through laser fluorescence of the tooth with a Diagnodent probe (Diagnodent, Kavo, Madrid, Spain)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01975545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Down Syndrome
Intervention  ICMJE
  • Drug: Fluor varnish
    Dental varnish will be applied to one anterior superior teeth in a random side.
    Other Name: Fluor dental varnish
  • 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.
Study Arms  ICMJE
  • Active Comparator: Fluor varnish
    Fluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein)
    Intervention: Drug: Fluor varnish
  • Experimental: Fluor varnish with nanoparticles
    Fluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein) plus 25% 50 nm silver nanoparticles.
    Intervention: Drug: Fluor varnish with nanoparticles
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 28, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01975545
Other Study ID Numbers  ICMJE MCIC-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Claudia Butrón Téllez Girón, Universidad Autonoma de San Luis Potosí
Study Sponsor  ICMJE Universidad Autonoma de San Luis Potosí
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mauricio Pierdant-Pérez, Md, MSc Universidad Autónoma de San Luis Potosí
PRS Account Universidad Autonoma de San Luis Potosí
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP