<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03235960</url>
  </required_header>
  <id_info>
    <org_study_id>001-04</org_study_id>
    <nct_id>NCT03235960</nct_id>
  </id_info>
  <brief_title>Efficacy of Glass-ionomer Fissure Sealants</brief_title>
  <official_title>Clinical Efficacy of Glass-ionomer Fissure Sealants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association of Paediatric and Preventive Dentists of Serbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Association of Paediatric and Preventive Dentists of Serbia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite numerous techniques for enamel protection, occlusal caries still remains a problem.&#xD;
      Sealing pits and fissures is considered to be an effective way of preventing caries&#xD;
      development. Glass-ionomer cements are mainly recommended for pits and fissures sealing for&#xD;
      two reasons. First, they are less susceptible to moisture which allows their use in&#xD;
      noncooperable children or in partially erupted teeth where isolation could be a problem, and&#xD;
      secondly, due to their potential to act as a fluoride reservoir making enamel more resistant&#xD;
      to demineralisation. The purpose of the study is to clinically examine the caries-preventive&#xD;
      effect of a glass-ionomer material for fissure protection in newly erupted permanent molars&#xD;
      in children with low, moderate, and high caries-risk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite numerous techniques for enamel protection, such as topical fluorides, calcium&#xD;
      phosphate-based remineralization systems, xylitol, etc., occlusal caries still remains a&#xD;
      problem. A carious lesion occurs in pits and fissures of occlusal surfaces primarily due to&#xD;
      their specific anatomy, which is considered to be an ideal site for the retention of bacteria&#xD;
      and food remnants rendering mechanical means of debridement inaccessible. Sealing pits and&#xD;
      fissures is considered to be an effective way of preventing caries development. Today, there&#xD;
      is a wide spectrum of available sealing materials. Glass-ionomer cements are mainly&#xD;
      recommended for pits and fissures sealing for two reasons. First, they are less susceptible&#xD;
      to moisture which allows their use in noncooperable children or in partially erupted teeth&#xD;
      where isolation could be a problem, and secondly, due to their potential to act as a fluoride&#xD;
      reservoir making enamel more resistant to demineralisation. During last decades,&#xD;
      glass-ionomer cements of different physical and chemical properties were used for pits and&#xD;
      fissure sealing which probably contributed to variances in their clinical efficacy. The&#xD;
      purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer&#xD;
      material for fissure protection in newly erupted permanent molars in children with low,&#xD;
      moderate, and high caries-risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2004</start_date>
  <completion_date type="Anticipated">August 1, 2017</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>absence of caries</measure>
    <time_frame>every 12 months during 13 years</time_frame>
    <description>absence of caries on sealed tooth surfaces</description>
  </primary_outcome>
  <primary_outcome>
    <measure>retention of sealant</measure>
    <time_frame>every 12 months during 13 years</time_frame>
    <description>complete or partial retention</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Fissure Sealant</condition>
  <condition>Glass-ionomer Cement</condition>
  <condition>Permanent Molar</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>glass-ionomer fissure sealant</intervention_name>
    <description>The encapsulated glass-ionomer cement for fissure protection was applied onto the selected permanent molar according to the manufacturer's instruction</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy children who appeared for a regular dental examination&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least one recently erupted permanent molar with sound pits and fissures&#xD;
&#xD;
          -  healthy patients&#xD;
&#xD;
          -  possibility to perform a dental treatment&#xD;
&#xD;
          -  willing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  teeth with an obvious cavity, with a restoration or a sealant completely or partially&#xD;
             presented in the fissure system&#xD;
&#xD;
          -  medically compromised patients&#xD;
&#xD;
          -  non cooperative patients&#xD;
&#xD;
          -  not willing to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dejan Markovic, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Belgrade, School of Dental Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Belgrade, School of Dental Medicine</name>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Serbia</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Association of Paediatric and Preventive Dentists of Serbia</investigator_affiliation>
    <investigator_full_name>Dejan Markovic</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 27, 2018</submitted>
    <returned>February 6, 2019</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03235960
org study id: 001-04
nct id: NCT03235960
lead sponsor: 
has dmc: Yes
Despite numerous techniques for enamel protection, occlusal caries still remains a problem.
      Sealing pits and fissures is considered to be an effective way of preventing caries
      development. Glass-ionomer cements are mainly recommended for pits and fissures sealing for
      two reasons. First, they are less susceptible to moisture which allows their use in
      noncooperable children or in partially erupted teeth where isolation could be a problem, and
      secondly, due to their potential to act as a fluoride reservoir making enamel more resistant
      to demineralisation. The purpose of the study is to clinically examine the caries-preventive
      effect of a glass-ionomer material for fissure protection in newly erupted permanent molars
      in children with low, moderate, and high caries-risk.
Despite numerous techniques for enamel protection, such as topical fluorides, calcium
      phosphate-based remineralization systems, xylitol, etc., occlusal caries still remains a
      problem. A carious lesion occurs in pits and fissures of occlusal surfaces primarily due to
      their specific anatomy, which is considered to be an ideal site for the retention of bacteria
      and food remnants rendering mechanical means of debridement inaccessible. Sealing pits and
      fissures is considered to be an effective way of preventing caries development. Today, there
      is a wide spectrum of available sealing materials. Glass-ionomer cements are mainly
      recommended for pits and fissures sealing for two reasons. First, they are less susceptible
      to moisture which allows their use in noncooperable children or in partially erupted teeth
      where isolation could be a problem, and secondly, due to their potential to act as a fluoride
      reservoir making enamel more resistant to demineralisation. During last decades,
      glass-ionomer cements of different physical and chemical properties were used for pits and
      fissure sealing which probably contributed to variances in their clinical efficacy. The
      purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer
      material for fissure protection in newly erupted permanent molars in children with low,
      moderate, and high caries-risk.
observational model: Case-Only
time perspective: Prospective
measure: absence of caries
time frame: every 12 months during 13 years
description: absence of caries on sealed tooth surfaces
measure: retention of sealant
time frame: every 12 months during 13 years
description: complete or partial retention
intervention type: Device
intervention name: glass-ionomer fissure sealant
description: The encapsulated glass-ionomer cement for fissure protection was applied onto the selected permanent molar according to the manufacturer's instruction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dejan Markovic, PhD
role: Principal Investigator
affiliation: University of Belgrade, School of Dental Medicine
facility: 
country: Serbia
responsible party type: Principal Investigator
investigator affiliation: Association of Paediatric and Preventive Dentists of Serbia
investigator full name: Dejan Markovic
investigator title: professor
sharing ipd: No
submitted: August 27, 2018
returned: February 6, 2019