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

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Glass ionomer
Glass ionomer cement
-Glass ionomer-
-Glass ionomer cement-
Sponsored by
Fernanda Miori Pascon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring glass-ionomer cement, atraumatic restorative treatment, pit and fissure sealants

Eligibility Criteria

5 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Active Comparator

    Experimental

    Arm Label

    Ketac Molar® (3M/ESPE) - Glass ionomer

    Maxxion® (FGM) - Glass ionomer cement

    Ketac Molar® (3M/ESPE) - Glass ionomer -

    Maxxion® (FGM) - Glass ionomer cement -

    Arm Description

    Pit and fissure sealing using conventional glass-ionomer cement

    Pit and fissure sealing using conventional glass-ionomer cement

    Restoration using conventional glass-ionomer cement

    Restoration using conventional glass-ionomer cement

    Outcomes

    Primary Outcome Measures

    Number of the teeth with glass-ionomer cement retention and prevention of caries.
    Criteria established by Frencken et al. (1998) was used.
    Number of the teeth with good restoration and caries absence.
    Criteria established by Frencken et al. (1998) was used.

    Secondary Outcome Measures

    Frequency of loss of the sealing material and prevention of caries.
    Criteria established by Frencken et al. (1998) was used.

    Full Information

    First Posted
    January 12, 2016
    Last Updated
    January 20, 2016
    Sponsor
    Fernanda Miori Pascon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02659917
    Brief Title
    Performance of Glass-ionomer Cements: 2-year Follow-up
    Official Title
    Performance of Glass-ionomer Cements in the Pit and Fissure Sealing and Atraumatic Restorative Treatment: a Randomized 2-year Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2008 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    August 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Fernanda Miori Pascon

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries
    Keywords
    glass-ionomer cement, atraumatic restorative treatment, pit and fissure sealants

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    147 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ketac Molar® (3M/ESPE) - Glass ionomer
    Arm Type
    Active Comparator
    Arm Description
    Pit and fissure sealing using conventional glass-ionomer cement
    Arm Title
    Maxxion® (FGM) - Glass ionomer cement
    Arm Type
    Experimental
    Arm Description
    Pit and fissure sealing using conventional glass-ionomer cement
    Arm Title
    Ketac Molar® (3M/ESPE) - Glass ionomer -
    Arm Type
    Active Comparator
    Arm Description
    Restoration using conventional glass-ionomer cement
    Arm Title
    Maxxion® (FGM) - Glass ionomer cement -
    Arm Type
    Experimental
    Arm Description
    Restoration using conventional glass-ionomer cement
    Intervention Type
    Other
    Intervention Name(s)
    Glass ionomer
    Intervention Description
    Application of preventive agent
    Intervention Type
    Other
    Intervention Name(s)
    Glass ionomer cement
    Intervention Description
    Application of preventive agent
    Intervention Type
    Other
    Intervention Name(s)
    -Glass ionomer-
    Intervention Description
    Atraumatic Restorative Treatment
    Intervention Type
    Other
    Intervention Name(s)
    -Glass ionomer cement-
    Intervention Description
    Atraumatic Restorative Treatment
    Primary Outcome Measure Information:
    Title
    Number of the teeth with glass-ionomer cement retention and prevention of caries.
    Description
    Criteria established by Frencken et al. (1998) was used.
    Time Frame
    6-month
    Title
    Number of the teeth with good restoration and caries absence.
    Description
    Criteria established by Frencken et al. (1998) was used.
    Time Frame
    6-month
    Secondary Outcome Measure Information:
    Title
    Frequency of loss of the sealing material and prevention of caries.
    Description
    Criteria established by Frencken et al. (1998) was used.
    Time Frame
    6-month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Raquel V Rodrigues, PhD Student
    Organizational Affiliation
    Piracicaba Dental School - University of Campinas
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ana Carolina G Luciano, DDS
    Organizational Affiliation
    Piracicaba Dental School - University of Campinas
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kelly MS Moreira, MS Student
    Organizational Affiliation
    Piracicaba Dental School - University of Campinas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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