<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/NCT03005405</url>
  </required_header>
  <id_info>
    <org_study_id>SEALANT-CARDEC02</org_study_id>
    <nct_id>NCT03005405</nct_id>
  </id_info>
  <brief_title>Cost-efficacy of Sealing Moderate Caries Lesions in Occlusal Surfaces of Primary Molars</brief_title>
  <official_title>Cost-efficacy and Applicability of the Treatment of Moderate Caries Using Sealants as an Alternative to the Restorations on Occlusal Surfaces of Deciduous Teeth: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This protocol aims to assess the cost-efficacy and applicability of the treatment of lesions&#xD;
      moderate caries using sealants as an alternative to the restorations on occlusal surfaces of&#xD;
      deciduous teeth. Initially, a non-inferiority study was designed in order to verify if&#xD;
      sealing could be non-inferior than restoration. In this case, it could be preferable since it&#xD;
      is less invasive. Therefore, cost will be put forward into the analysis considering even&#xD;
      reintervention during the follow-ups (cost-efficacy analyses). Finally, the acceptability&#xD;
      could be another differential point between treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to evaluate the cost-efficacy and applicability of the treatment of lesions&#xD;
      moderate caries using sealants as an alternative to the restorations on occlusal surfaces of&#xD;
      deciduous teeth. 96 children aged 3-6 years will be selected. Children must have at least one&#xD;
      occlusal surface classified as scores 3 or 4 of International Caries Detection and Assessment&#xD;
      System (ICDAS). Children will be randomly allocated according to the treatment: glass ionomer&#xD;
      sealant and restoration with glass ionomer. After treatment, teeth will be assessed&#xD;
      clinically after 6, 12, 18 and 24 months by trained and blinded examiners regarding the&#xD;
      treatment received. The need of reintervention initially treated, either by failures that&#xD;
      require repeating of the same procedure or for progression of caries lesions will be&#xD;
      considered as primary outcomes. The secondary outcomes will be the chil's acceptability to&#xD;
      the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2015</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Need of reintervention</measure>
    <time_frame>24 months</time_frame>
    <description>Need of reintervention will be considered as all failures after initial treatment that demand repair and/or caries progression associated to the treated lesion at baseline.&#xD;
After cleaning, It will be analyzed the clinical evaluation of restorations and sealants, will be assessed the presence of caries lesions in dentin and / or evolution of ICDAS scores and if will be necessary other types of treatment, such as endodontics and extraction of teeth included.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child's reported discomfort</measure>
    <time_frame>1st day</time_frame>
    <description>The discomfort will be an outcome collected right after the end of treatment, using Wong baker scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of treatments</measure>
    <time_frame>1st day</time_frame>
    <description>Time spent in interventions will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>restoration - control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Restoration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sealant - test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sealant</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ionomer Restoration (control)</intervention_name>
    <description>Restoration of moderate caries lesions after partial caries removal using high viscosity glass ionomer cements</description>
    <arm_group_label>restoration - control</arm_group_label>
    <other_name>glass ionomer cement, restoration</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ionomer Sealant (test)</intervention_name>
    <description>Sealing of moderate caries lesions without any caries removal or cavity opening.</description>
    <arm_group_label>sealant - test</arm_group_label>
    <other_name>glass ionomer cement, sealant</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oral hygiene orientation and professional fluoride application</intervention_name>
    <description>Oral hygiene orientation and professional fluoride application</description>
    <arm_group_label>restoration - control</arm_group_label>
    <arm_group_label>sealant - test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        They will be included in this study children:&#xD;
&#xD;
          -  aged 3 years and 6 years and 11 months;&#xD;
&#xD;
          -  With complete primary dentition;&#xD;
&#xD;
          -  Who have at least one active caries lesion score 3 or 4 ICDAS, in the occlusal molars&#xD;
             surfaces.&#xD;
&#xD;
          -  Who have assented to participate and whose parents have consented to their&#xD;
             participation by signing the Instrument of Consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  who have medical and / or behavioral conditions that require special considerations&#xD;
             regarding handling / treatment;&#xD;
&#xD;
          -  who are involved in other research that may impact on this study;&#xD;
&#xD;
          -  whose parents that not agree in participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mariana M Braga, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of São Paulo</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>05508-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>March 20, 2018</last_update_submitted>
  <last_update_submitted_qc>March 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Mariana Minatel Braga</investigator_full_name>
    <investigator_title>PhD, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Dental Caries</keyword>
  <keyword>Primary tooth</keyword>
  <keyword>Ionomer Sealants</keyword>
  <keyword>Glass Ionomer Restoration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methamphetamine</mesh_term>
    <mesh_term>Fluorides</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Publication of all results, accessibility to data if necessary</ipd_description>
  </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/NCT03005405
org study id: SEALANT-CARDEC02
nct id: NCT03005405
lead sponsor: 
has dmc: Yes
This protocol aims to assess the cost-efficacy and applicability of the treatment of lesions
      moderate caries using sealants as an alternative to the restorations on occlusal surfaces of
      deciduous teeth. Initially, a non-inferiority study was designed in order to verify if
      sealing could be non-inferior than restoration. In this case, it could be preferable since it
      is less invasive. Therefore, cost will be put forward into the analysis considering even
      reintervention during the follow-ups (cost-efficacy analyses). Finally, the acceptability
      could be another differential point between treatments.
This study aims to evaluate the cost-efficacy and applicability of the treatment of lesions
      moderate caries using sealants as an alternative to the restorations on occlusal surfaces of
      deciduous teeth. 96 children aged 3-6 years will be selected. Children must have at least one
      occlusal surface classified as scores 3 or 4 of International Caries Detection and Assessment
      System (ICDAS). Children will be randomly allocated according to the treatment: glass ionomer
      sealant and restoration with glass ionomer. After treatment, teeth will be assessed
      clinically after 6, 12, 18 and 24 months by trained and blinded examiners regarding the
      treatment received. The need of reintervention initially treated, either by failures that
      require repeating of the same procedure or for progression of caries lesions will be
      considered as primary outcomes. The secondary outcomes will be the chil's acceptability to
      the treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Need of reintervention
time frame: 24 months
description: Need of reintervention will be considered as all failures after initial treatment that demand repair and/or caries progression associated to the treated lesion at baseline.
After cleaning, It will be analyzed the clinical evaluation of restorations and sealants, will be assessed the presence of caries lesions in dentin and / or evolution of ICDAS scores and if will be necessary other types of treatment, such as endodontics and extraction of teeth included.
measure: Child's reported discomfort
time frame: 1st day
description: The discomfort will be an outcome collected right after the end of treatment, using Wong baker scale
measure: Duration of treatments
time frame: 1st day
description: Time spent in interventions will be recorded.
arm group label: restoration - control
arm group type: Active Comparator
description: Restoration
arm group label: sealant - test
arm group type: Experimental
description: Sealant
intervention type: Procedure
intervention name: Ionomer Restoration (control)
description: Restoration of moderate caries lesions after partial caries removal using high viscosity glass ionomer cements
arm group label: restoration - control
other name: glass ionomer cement, restoration
intervention type: Procedure
intervention name: Ionomer Sealant (test)
description: Sealing of moderate caries lesions without any caries removal or cavity opening.
arm group label: sealant - test
other name: glass ionomer cement, sealant
intervention type: Procedure
intervention name: Oral hygiene orientation and professional fluoride application
description: Oral hygiene orientation and professional fluoride application
arm group label: restoration - control
arm group label: sealant - test
criteria: 
gender: All
minimum age: 3 Years
maximum age: 6 Years
healthy volunteers: No
last name: Mariana M Braga, PhD
role: Principal Investigator
affiliation: University of São Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Mariana Minatel Braga
investigator title: PhD, Associate Professor
mesh term: Dental Caries
mesh term: Methamphetamine
mesh term: Fluorides
sharing ipd: Yes
ipd description: Publication of all results, accessibility to data if necessary