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Performance of Glass-ionomer Cements: 2-year Follow-up

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ClinicalTrials.gov Identifier: NCT02659917
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Fernanda Miori Pascon, University of Campinas, Brazil

Tracking Information
First Submitted Date  ICMJE January 12, 2016
First Posted Date  ICMJE January 21, 2016
Last Update Posted Date January 21, 2016
Study Start Date  ICMJE August 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2016)
  • Number of the teeth with glass-ionomer cement retention and prevention of caries. [ Time Frame: 6-month ]
    Criteria established by Frencken et al. (1998) was used.
  • Number of the teeth with good restoration and caries absence. [ Time Frame: 6-month ]
    Criteria established by Frencken et al. (1998) was used.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2016)
Frequency of loss of the sealing material and prevention of caries. [ Time Frame: 6-month ]
Criteria established by Frencken et al. (1998) was used.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Performance of Glass-ionomer Cements: 2-year Follow-up
Official Title  ICMJE Performance of Glass-ionomer Cements in the Pit and Fissure Sealing and Atraumatic Restorative Treatment: a Randomized 2-year Clinical Trial
Brief Summary The purpose of this randomized clinical trial was evaluate the performance of two conventional glass-ionomer cements in the pit and fissure sealing and atraumatic restorative treatment in high caries risk children.
Detailed Description Sealants were applied on sound permanent first molars by "press finger technique" and carious deciduous molars that required either class I or class II restorations were restored according to manufacturers' recommendations in order to caries prevention and control.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • Other: Glass ionomer
    Application of preventive agent
  • Other: Glass ionomer cement
    Application of preventive agent
  • Other: -Glass ionomer-
    Atraumatic Restorative Treatment
  • Other: -Glass ionomer cement-
    Atraumatic Restorative Treatment
Study Arms  ICMJE
  • Active Comparator: Ketac Molar® (3M/ESPE) - Glass ionomer
    Pit and fissure sealing using conventional glass-ionomer cement
    Intervention: Other: Glass ionomer
  • Experimental: Maxxion® (FGM) - Glass ionomer cement
    Pit and fissure sealing using conventional glass-ionomer cement
    Intervention: Other: Glass ionomer cement
  • Active Comparator: Ketac Molar® (3M/ESPE) - Glass ionomer -
    Restoration using conventional glass-ionomer cement
    Intervention: Other: -Glass ionomer-
  • Experimental: Maxxion® (FGM) - Glass ionomer cement -
    Restoration using conventional glass-ionomer cement
    Intervention: Other: -Glass ionomer cement-
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2016)
147
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Volunteers that having at least two permanent first molars of opposite sides of the mouth, erupted in the oral cavity, caries-free and high-risk disease (presence of white spots, history of caries, plaque in smooth surfaces and gingivitis);
  • Children who had one or two bilateral matched pairs of carious deciduous molars that required either class I or class II restorations.

Exclusion Criteria:

  • Children who did not meet the minimum requirements for the achievement of sealants or parents / guardians did not agree to participate;
  • No history of spontaneous pulpal pain.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02659917
Other Study ID Numbers  ICMJE 3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fernanda Miori Pascon, University of Campinas, Brazil
Study Sponsor  ICMJE Fernanda Miori Pascon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raquel V Rodrigues, PhD Student Piracicaba Dental School - University of Campinas
Principal Investigator: Ana Carolina G Luciano, DDS Piracicaba Dental School - University of Campinas
Principal Investigator: Kelly MS Moreira, MS Student Piracicaba Dental School - University of Campinas
PRS Account University of Campinas, Brazil
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP