<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/NCT03785769</url>
  </required_header>
  <id_info>
    <org_study_id>Unib4</org_study_id>
    <nct_id>NCT03785769</nct_id>
  </id_info>
  <brief_title>Pre-etching of Dentin Before Restorations With High Viscosity Glass Ionomer Cement</brief_title>
  <acronym>CEPECO4</acronym>
  <official_title>Effect of Pre-etching of Dentin on Survival of Restorations With High Viscosity Glass Ionomer Cement in the Atraumatic Restorative Treatment - Randomized Clinical Trial Restorations With High Viscosity Glass Ionomer Cement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Ibirapuera</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Ibirapuera</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this randomized clinical trial is to evaluate the survival of restoration&#xD;
      with high viscosity glass ionomer cement (HVGIC) with pre-etching with polyacrilic acid&#xD;
      compared with no pre-etching in order to treat occlusoproximais caries lesion in primary&#xD;
      molars, as well as the impact of those treatments in the caries lesion progression, the&#xD;
      cost-efficacy of the procedures and the discomfort reported by the patient. Children of 4 to&#xD;
      8 years will be selected in the Pediatric Dentistry Clinic of Universidade Ibirapuera. 192&#xD;
      teeth will be randomized in 2 experimental groups: (1) HVGIC restoration with pre-etching and&#xD;
      (2) HVGIC restoration with no pre-etching. Will be considered as primary outcome the survival&#xD;
      of the restoration evaluated after 6, 12, and 24 months by two trained examiners. The carious&#xD;
      lesions progression will be evaluated after 24 months of follow-up. The time of the&#xD;
      treatments and the cost of the materials will be considered to estimate the cost-efficacy of&#xD;
      each treatment. The discomfort reported by the participant will be measured after each&#xD;
      procedure following the Wong-Baker scale. For the primary outcome, Kaplan-Meier survival and&#xD;
      the Long-Rank test will be used in order to compare the two groups. Cox regression will be&#xD;
      performed in order to evaluate thee influence of explanatory variables on the outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The Outbreak of COVID-19.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 1, 2022</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Double-blind (Patient and Examiner) will not be able to blinding the operator due to the obvious difference between the techniques</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Survival of restorations</measure>
    <time_frame>24 months</time_frame>
    <description>Comparing the survival of HVGIC restorations without pre-etching with HVGIC restorations with pre-etching by clinical assessment using a criteria proposed by Roleveld et al., 2006.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration</measure>
    <time_frame>Immediately after the restoration and 24 months</time_frame>
    <description>The caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration and after 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-efficacy</measure>
    <time_frame>24 months.</time_frame>
    <description>The duration of the treatments (time of treatment) and the cost of the materials used will be considered for the estimation of the cost-efficacy of the treatments by a ratio - cost/efficacy, being efficacy considered the tooth survival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale</measure>
    <time_frame>Immediately after the treatment</time_frame>
    <description>Children-reported discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale. The scale present 6 different faces since &quot;very happy&quot; until &quot;very sad&quot; with the treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>HVGIC restoration with pre-etching</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pre-etching of the surface with polyacrylic acid for 10 s, followed by HVGIC restoration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HVGIC restoration with non pre-etching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HVGIC restoration without the pre-etching of the surface.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>HVGIC restoration with pre-etching</intervention_name>
    <description>Pre-etching of the surface with polyacrylic acid for 10 s, followed by washing and drying the cavity with cotton balls; and fill with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.</description>
    <arm_group_label>HVGIC restoration with pre-etching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>HVGIC restoration with non pre-etching</intervention_name>
    <description>Restoration with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.</description>
    <arm_group_label>HVGIC restoration with non pre-etching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with carious lesion of occlusoproximais in primary molars&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded with special needs, using orthodontics devices and/or&#xD;
             systemic diseases which may affect the oral cavity.&#xD;
&#xD;
          -  Also, teeth with pulp exposure, spontaneous pain, mobility, presence of abscess or&#xD;
             fistula next to the tooth, teeth with restorations, sealants or enamel formation&#xD;
             defects will also be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tamara Kerber Tedesco</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>04545-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>May 30, 2022</last_update_submitted>
  <last_update_submitted_qc>May 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Ibirapuera</investigator_affiliation>
    <investigator_full_name>Tamara Kerber Tedesco</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data will be available on Mendeley database.</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/NCT03785769
org study id: Unib4
nct id: NCT03785769
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this randomized clinical trial is to evaluate the survival of restoration
      with high viscosity glass ionomer cement (HVGIC) with pre-etching with polyacrilic acid
      compared with no pre-etching in order to treat occlusoproximais caries lesion in primary
      molars, as well as the impact of those treatments in the caries lesion progression, the
      cost-efficacy of the procedures and the discomfort reported by the patient. Children of 4 to
      8 years will be selected in the Pediatric Dentistry Clinic of Universidade Ibirapuera. 192
      teeth will be randomized in 2 experimental groups: (1) HVGIC restoration with pre-etching and
      (2) HVGIC restoration with no pre-etching. Will be considered as primary outcome the survival
      of the restoration evaluated after 6, 12, and 24 months by two trained examiners. The carious
      lesions progression will be evaluated after 24 months of follow-up. The time of the
      treatments and the cost of the materials will be considered to estimate the cost-efficacy of
      each treatment. The discomfort reported by the participant will be measured after each
      procedure following the Wong-Baker scale. For the primary outcome, Kaplan-Meier survival and
      the Long-Rank test will be used in order to compare the two groups. Cox regression will be
      performed in order to evaluate thee influence of explanatory variables on the outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Double-blind (Patient and Examiner) will not be able to blinding the operator due to the obvious difference between the techniques
measure: Survival of restorations
time frame: 24 months
description: Comparing the survival of HVGIC restorations without pre-etching with HVGIC restorations with pre-etching by clinical assessment using a criteria proposed by Roleveld et al., 2006.
measure: Caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration
time frame: Immediately after the restoration and 24 months
description: The caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration and after 24 months.
measure: Cost-efficacy
time frame: 24 months.
description: The duration of the treatments (time of treatment) and the cost of the materials used will be considered for the estimation of the cost-efficacy of the treatments by a ratio - cost/efficacy, being efficacy considered the tooth survival.
measure: Discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale
time frame: Immediately after the treatment
description: Children-reported discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale. The scale present 6 different faces since "very happy" until "very sad" with the treatment.
arm group label: HVGIC restoration with pre-etching
arm group type: Active Comparator
description: Pre-etching of the surface with polyacrylic acid for 10 s, followed by HVGIC restoration.
arm group label: HVGIC restoration with non pre-etching
arm group type: Experimental
description: HVGIC restoration without the pre-etching of the surface.
intervention type: Procedure
intervention name: HVGIC restoration with pre-etching
description: Pre-etching of the surface with polyacrylic acid for 10 s, followed by washing and drying the cavity with cotton balls; and fill with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.
arm group label: HVGIC restoration with pre-etching
intervention type: Procedure
intervention name: HVGIC restoration with non pre-etching
description: Restoration with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.
arm group label: HVGIC restoration with non pre-etching
criteria: 
gender: All
minimum age: 4 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Ibirapuera
investigator full name: Tamara Kerber Tedesco
investigator title: Principal investigator
mesh term: Dental Caries
sharing ipd: Yes
ipd description: Individual participant data will be available on Mendeley database.