Resin Infiltratration on the Sealing of Proximal Early Caries

August 21, 2012 updated by: Julio Eduardo do Amaral, Universidade Federal de Santa Maria

Resin Infiltration on Teh Sealing of Proximal Early Caries Lesins: a Randomized Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

39

Phase

  • Not Applicable

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

  • Brazil
    • Rio Grande Do Sul
      • Santa Maria, Rio Grande Do Sul, Brazil, 97105-900
        • Recruiting
        • Federal University of Santa Maria
        • Contact:
        • Principal Investigator:
          • Julio Zenkner, MsC

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

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICON - low viscosity resin
APPLICATION OF A LOW VISCOSITY RESIN IN EARLY PROXIMAL CARIES LESIONS
Other: ICON
LOW VISCOSITY RESIN WILL BE APPLIED IN EARLY PROXIMAL CARIES LESIONS
Other Names:
  • ICON (DMG) Hamburg Germany
Active Comparator: INSTRUCTIONS ORAL HYGIENE
INSTRUCTION ORAL HYGIENE AND DIET AND TOOPICAL FLUORIDE APPLICATIONS
Behavioral: instruction oral hygiene
Instructions diet and hygiene oral and topical fluoride

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Universidade Federal de Santa Maria

Investigators

  • Principal Investigator: Julio E Zenkner, MsC, Universidade Federal de Santa Maria

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

April 1, 2011

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

August 3, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Estimate)

August 23, 2012

Last Update Submitted That Met QC Criteria

August 21, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0347.0243.000-10

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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