Resin Infiltratration on the Sealing of Proximal Early Caries

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014