Fluor Varnish With Silver Nanoparticles for Dental Remine... | NCT01975545

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

NCT01975545

Sponsor

Universidad Autonoma de San Luis Potosí

Status

Unknown status

Last Update Posted

Mar 7, 2014Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Down Syndrome

Interventions

Fluor varnish
Fluor varnish with nanoparticles

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Apr 2014Estimated

Completion Date

May 2014Estimated

First Submitted Date

Sep 3, 2013

First Submission Date that Met QC Criteria

Oct 28, 2013

First Posted Date

Nov 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2014

Last Update Posted Date

Mar 7, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia Butrón Téllez Girón, Claudia Butrón-TéllezGiron, Dent., Universidad Autonoma de San Luis PotosíPrincipal Investigator

Lead Sponsor

Universidad Autonoma de San Luis PotosíOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Fluor varnish	Drug	Dental varnish will be applied to one anterior superior teeth in a random side.	Fluor varnish

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mauricio Pierdant-Pérez, Md, MSc	Universidad Autonoma de San Luis Potosí	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad Autónoma de San Luis Potosí		San Luis Potosí City	San Luis Potosí	78210	Mexico

Type	Date	Date Unknown
Release	Mar 25, 2014
Reset	Apr 25, 2014
Release	Dec 16, 2014
Reset	Dec 27, 2014

Submission Tracking

Estimated Results First Submitted Date

Mar 25, 2014

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 25, 2014			Apr 25, 2014
Dec 16, 2014

Condition Browse Module

MeSH Terms

ID	Term
D004314	Down Syndrome

Ancestor Terms

ID	Term
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053758	Nanoparticles
C586932	colloidal silver

Ancestor Terms

ID	Term
D049329	Nanostructures
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture

Browse Leaves

Not provided

Browse Branches

Not provided