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Resin Infiltratration on the Sealing of Proximal Early Caries

This study is currently recruiting participants.
Verified August 2012 by Universidade Federal de Santa Maria
Sponsor:
Information provided by (Responsible Party):
Julio Eduardo do Amaral, Universidade Federal de Santa Maria
ClinicalTrials.gov Identifier:
NCT01659463
First received: August 3, 2012
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention
Tooth; Lesion, White Spot Lesions
 Other: ICON
Behavioral: instruction oral hygiene

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Resin Infiltration on Teh Sealing of Proximal Early Caries Lesins: a Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidade Federal de Santa Maria:

Primary Outcome Measures:
  • caries progression in the proximal surfaces [ Time Frame: One year after interventions ] [ Designated as safety issue: No ]
    progression in the proximal surfaces will be compared with two procedures.


Estimated Enrollment: 39
Study Start Date: April 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   9 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659463

Contacts
Contact: Rafaela Correia, student +555599721234 rafaela.tc@gmail.com

Locations
Brazil
Federal University of Santa Maria Recruiting
Santa Maria, Rio Grande Do Sul, Brazil, 97105-900
Contact: RAFAELA CORREIA, STUDENT     +555599721234     rafaela.tc@gmail.com    
Principal Investigator: Julio Zenkner, MsC            
Sponsors and Collaborators
Universidade Federal de Santa Maria
Investigators
Principal Investigator: Julio E Zenkner, MsC Universidade Federal de Santa Maria
  More Information

No publications provided

Responsible Party: Julio Eduardo do Amaral, MsC, Universidade Federal de Santa Maria
ClinicalTrials.gov Identifier: NCT01659463     History of Changes
Other Study ID Numbers: 0347.0243.000-10
Study First Received: August 3, 2012
Last Updated: August 21, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal de Santa Maria:
CARIES INFILTRATION
CARIES LESION
INFILTRANT

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 23, 2013