Resin Infiltratration on the Sealing of Proximal Early Ca... | NCT01659463

Studies
Resin Infiltratration on the Sealing of Proximal Early Caries

NCT01659463

Sponsor

Universidade Federal de Santa Maria

Status

Unknown status

Last Update Posted

Aug 23, 2012Estimated

Enrollment

39Estimated

Phase

Not Applicable

Conditions

Tooth; Lesion, White Spot Lesions

Interventions

ICON
instruction oral hygiene

Countries

Brazil

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Sep 2012Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Aug 3, 2012

First Submission Date that Met QC Criteria

Aug 6, 2012

First Posted Date

Aug 7, 2012Estimated

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

Aug 21, 2012

Last Update Posted Date

Aug 23, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Julio Eduardo do Amaral, MsC, Universidade Federal de Santa MariaPrincipal Investigator

Lead Sponsor

Universidade Federal de Santa MariaOTHER

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

Material for caries prevention dont have better results compared with non-operatory interventions.

Detailed Description

Two gruops will be compared. One using ICON and another gruop with non-operatory interventions consisted in hygiene instrutions and fluoride topical application. The caries progression will be evalueted with radiographic observation.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICON - low viscosity resin	Experimental	APPLICATION OF A LOW VISCOSITY RESIN IN EARLY PROXIMAL CARIES LESIONS	Other: ICON
INSTRUCTIONS ORAL HYGIENE	Active Comparator	INSTRUCTION ORAL HYGIENE AND DIET AND TOOPICAL FLUORIDE APPLICATIONS	Behavioral: instruction oral hygiene

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ICON	Other	LOW VISCOSITY RESIN WILL BE APPLIED IN EARLY PROXIMAL CARIES LESIONS	ICON - low viscosity resin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
caries progression in the proximal surfaces	progression in the proximal surfaces will be compared with two procedures.	One year after interventions

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Two early caries lesion in the same patient, lesion with the same radiolucencies images

Exclusion Criteria:

Pregnancy, use of orthodontics appliences, use of drugs modified salivar flow, ausence of adjacent teeth

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rafaela Correia, student	Contact	+555599721234		rafaela.tc@gmail.com

Overall Officials

Name	Affiliation	Role
Julio E Zenkner, MsC	Universidade Federal de Santa Maria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal University of Santa Maria	Recruiting	Santa Maria	Rio Grande do Sul	97105-900	Brazil