<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/NCT03034837</url>
  </required_header>
  <id_info>
    <org_study_id>201503121</org_study_id>
    <nct_id>NCT03034837</nct_id>
  </id_info>
  <brief_title>Effectiveness and Economic Evaluation of Glass Ionomer Material Using as Dental Sealant</brief_title>
  <official_title>Economic Evaluation of ART Sealant in Preventing Pit and Fissure Caries in Permanent First Molars in an Asia Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhengzhou University</source>
  <brief_summary>
    <textblock>
      Eruption of the first permanent molar is the earliest in our oral cavity, leading to a high&#xD;
      occurrence of dental caries in its pits and fissures. Early prevention of pit and fissure&#xD;
      caries in this tooth is therefore of great importance for the preservation of a healthy&#xD;
      dentition in one's life long time.&#xD;
&#xD;
      It has been shown that sealing the occlusal surface with pit and fissure sealant is a highly&#xD;
      effective method to prevent pit and fissure caries. It has also been shown that the&#xD;
      performance of sealing pits and fissures by glass ionomer materia l (the high viscosity,&#xD;
      classification type 2 GIC material) using finger press method used in the atraumatic&#xD;
      restoration method is as significant as that of using the traditional resin sealant material&#xD;
      and technique.&#xD;
&#xD;
      The purpose of this study is to evaluate the long-term cost-effectiveness performance of the&#xD;
      two sealing materials in the prevention of pits and fissures caries in young permanent molars&#xD;
      of schoolchildren in a dental public health program to be held in primary schools. The&#xD;
      findings will provide valuable information for decision making on the election of proper&#xD;
      material and method for use in dental public program, especially for child population in the&#xD;
      rural or social-economically deprived areas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary school children will be recruited and cluster randomized into three groups. Baseline&#xD;
      dental check-up will be conducted to all the recruited children and dental status will be&#xD;
      recorded. Placement of resin sealant or sealant using the glass ionomer material to the&#xD;
      eligible permanent first molars or providing of oral health education will be interventions&#xD;
      to the three groups respecively according to the group allocation. All the interventions will&#xD;
      be provided only once in this study, and the children will be followed for at least 24 months&#xD;
      at an six month interval to motor the dental caries of the included permanent first molars.&#xD;
      Cost-effectiveness of placement of resin sealant and glass ionomer sealant will be evaluated&#xD;
      and reported.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cost-effectiveness of sealing</measure>
    <time_frame>24-month</time_frame>
    <description>the incrental cost-effectiveness ratio of different sealing material used in this study in preventing pit and fissure caries in the permanent molars.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">329</enrollment>
  <condition>Glass Ionomer Cement</condition>
  <condition>Cost-effectiveness</condition>
  <condition>Pit and Fissure Caries (Disorder)</condition>
  <arm_group>
    <arm_group_label>Resin sealant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sealing pit and fissures of the included permanent first molars using &quot;SDI conseal f&quot; resin sealant material once at the baseline of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ART sealant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sealing pit and fissures of the included permanent first molars using &quot;3M ESPE KetacTM Molar Easymix&quot; glass ionomer cement material once at the baseline of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>resin sealant</intervention_name>
    <description>Sealing the occlusal surface of the included molars using the market product of SDI conseal f once.</description>
    <arm_group_label>Resin sealant</arm_group_label>
    <other_name>SDI conseal f</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ART sealant</intervention_name>
    <description>Sealing the occlusal surface of the included molars using the market product of 3M ESPE KetacTM Molar Easymix&quot; glass ionomer cement once.</description>
    <arm_group_label>ART sealant</arm_group_label>
    <other_name>GIC sealant</other_name>
    <other_name>3M ESPE KetacTM Molar Easymix&quot; glass ionomer cement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  generally healthy grade 1-2 school children&#xD;
&#xD;
          -  with written parental consent&#xD;
&#xD;
          -  with at least 1 sound and fully erupted permanent first molar&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Can not cooperate with the treatment&#xD;
&#xD;
          -  Can not obtain the child's parental consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Baoying Liu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhengzhou University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jianxinjie Primary School</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruhelu Primary School</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>July 4, 2019</last_update_submitted>
  <last_update_submitted_qc>July 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhengzhou University</investigator_affiliation>
    <investigator_full_name>Liu Baoying</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03034837
org study id: 201503121
nct id: NCT03034837
lead sponsor: 
Eruption of the first permanent molar is the earliest in our oral cavity, leading to a high
      occurrence of dental caries in its pits and fissures. Early prevention of pit and fissure
      caries in this tooth is therefore of great importance for the preservation of a healthy
      dentition in one's life long time.

      It has been shown that sealing the occlusal surface with pit and fissure sealant is a highly
      effective method to prevent pit and fissure caries. It has also been shown that the
      performance of sealing pits and fissures by glass ionomer materia l (the high viscosity,
      classification type 2 GIC material) using finger press method used in the atraumatic
      restoration method is as significant as that of using the traditional resin sealant material
      and technique.

      The purpose of this study is to evaluate the long-term cost-effectiveness performance of the
      two sealing materials in the prevention of pits and fissures caries in young permanent molars
      of schoolchildren in a dental public health program to be held in primary schools. The
      findings will provide valuable information for decision making on the election of proper
      material and method for use in dental public program, especially for child population in the
      rural or social-economically deprived areas.
Primary school children will be recruited and cluster randomized into three groups. Baseline
      dental check-up will be conducted to all the recruited children and dental status will be
      recorded. Placement of resin sealant or sealant using the glass ionomer material to the
      eligible permanent first molars or providing of oral health education will be interventions
      to the three groups respecively according to the group allocation. All the interventions will
      be provided only once in this study, and the children will be followed for at least 24 months
      at an six month interval to motor the dental caries of the included permanent first molars.
      Cost-effectiveness of placement of resin sealant and glass ionomer sealant will be evaluated
      and reported.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Investigator)
measure: cost-effectiveness of sealing
time frame: 24-month
description: the incrental cost-effectiveness ratio of different sealing material used in this study in preventing pit and fissure caries in the permanent molars.
arm group label: Resin sealant
arm group type: Active Comparator
description: Sealing pit and fissures of the included permanent first molars using "SDI conseal f" resin sealant material once at the baseline of the study.
arm group label: ART sealant
arm group type: Experimental
description: Sealing pit and fissures of the included permanent first molars using "3M ESPE KetacTM Molar Easymix" glass ionomer cement material once at the baseline of the study.
intervention type: Drug
intervention name: resin sealant
description: Sealing the occlusal surface of the included molars using the market product of SDI conseal f once.
arm group label: Resin sealant
other name: SDI conseal f
intervention type: Drug
intervention name: ART sealant
description: Sealing the occlusal surface of the included molars using the market product of 3M ESPE KetacTM Molar Easymix" glass ionomer cement once.
arm group label: ART sealant
other name: GIC sealant
other name: 3M ESPE KetacTM Molar Easymix" glass ionomer cement
criteria: 
gender: All
minimum age: 7 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Baoying Liu, PhD
role: Principal Investigator
affiliation: Zhengzhou University
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhengzhou University
investigator full name: Liu Baoying
investigator title: Dr.
sharing ipd: No