<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/NCT03785730</url>
  </required_header>
  <id_info>
    <org_study_id>Unib3</org_study_id>
    <nct_id>NCT03785730</nct_id>
  </id_info>
  <brief_title>Non-restorative Cavity Control in Anterior Cavitated Caries Lesion of Primary Teeth</brief_title>
  <acronym>CEPECO2</acronym>
  <official_title>Impact of Non-restorative Cavity Control on Proximal Carious Lesions of Anterior Primary Teeth on the Tooth Survival and Patient-centered Outcomes (CEPECO 2) - Study Protocol for a Non-inferiority Randomized Clinical Trial</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>
      Background: Studies have questioned the necessity of restoring cavitated carious lesion on&#xD;
      primary teeth, once the control of biofilm is the most important factor to arrest these&#xD;
      lesions. This randomized clinical trial aimed to compare the survival of teeth treated with a&#xD;
      non-restorative cavity control (NRCC) compared to resin composite restorations (RCR) on&#xD;
      proximal carious lesion in anterior primary teeth, as well as the impact of these treatments&#xD;
      on patient-centered outcomes. Methods: A randomized clinical trial with two parallels arms&#xD;
      (1:1) will be conducted. Children between 3 and 6 years old will be selected from the Center&#xD;
      of Clinic Research of Pediatric Dentistry of Ibirapuera University (UNIB), a dental trailer&#xD;
      (FOUSP) located on Educational Complex Professor Carlos Osmarinho de Lima, the Pediatric&#xD;
      Dentistry Clinic of Santa Cecília University and from the Pediatric Dentistry Clinic of&#xD;
      University Center UNINOVAFAPI. One hundred and forty-eight teeth will be randomly distributed&#xD;
      in two experimental groups: (1) Selective removal of carious tissue and RCR; or (2) NRCC&#xD;
      through cavity enlargement using metallic sandpaper. The primary outcome will be tooth&#xD;
      survival after 6, 12, 18, and 24 months. The duration and the cost of dental treatments will&#xD;
      be considered for the estimation of the cost-effectiveness of the evaluated treatments. The&#xD;
      discomfort reported by the participants will be measured after each treatment using the FIS&#xD;
      scale. The participants' satisfaction and perception of the parents/legal guardians will be&#xD;
      evaluated through questionnaires. For the primary outcome, Kaplan-Meier's survival and&#xD;
      Long-Rank test will be used for comparison between the two groups. All the variables will be&#xD;
      modeled by Cox regression with shared fragility. Significance will be considered at 5%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This non-inferiority randomized controlled clinical trial, with two parallel groups with 1:1&#xD;
      allocation ratio, was approved by the Research Ethics Committee of Universidade Ibirapuera&#xD;
      (UNIB). The other centers involved are considered co-participants (Centro Universitário do&#xD;
      Norte - Uninorte , Centro Universitário Uninovafapi - UNINOVAFAPI, and School of Dentistry&#xD;
      from the University of Sao Paulo - FOUSP). Children aged 3 to 6 years with at least one&#xD;
      proximal cavitated lesion on anterior primary teeth will be selected from the Clinical&#xD;
      Pediatric Research Center. Teeth will be randomly allocated to selective removal of carious&#xD;
      tissue and resin composite restoration (RCR) or NRCC. Tooth survival after two years of&#xD;
      follow-up will be the primary outcome and cost-effectiveness, satisfaction, and discomfort&#xD;
      reported by participants and parents/guardians' perception will be the secondary outcomes.&#xD;
      Only patients who fulfill the eligibility criteria will be included in the study after the&#xD;
      legal guardians sign the informed consent form and the child consents to participate in the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Outbreak of COVID-19.&#xD;
  </why_stopped>
  <start_date type="Actual">April 30, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2025</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tooth survival by clinical assessment</measure>
    <time_frame>24 months</time_frame>
    <description>Comparing the survival of teeth treated with restoration of resin composite and with NRCC for lesions cavitated in anterior primary teeth by clinical assessment, considering as success when the teeth will be without clinical signs or symptoms of pulp pathology or exfoliated, with no need for more invasive interventions, such as pulpectomy or extraction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Discomfort regarding the treatment options by a Face image scale (FIS)</measure>
    <time_frame>Immediately after treatment</time_frame>
    <description>Children-reported discomfort regarding the treatment options by a Face image scale (FIS). The scale present 5 different faces since &quot;very happy&quot; (scored as 1) until &quot;very sad&quot; (scored as 5) with the treatment. Higher scores mean a worse discomfort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness analysis</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/effectiveness, being effectiveness considered the tooth survival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of parents / guardians evaluated through questionnaire</measure>
    <time_frame>Prior to treatment, immediately after and 6 months later.</time_frame>
    <description>Parents perception of the treatments will be evaluated through a questionnaire - &quot;Child's and parent's questionnaire about teeth appearance&quot; - with possible answers varying from very satisfied until insatisfied. After the questionnaire is applied for the parents/guardians, the anwsers will bem transformed in scores 1 to 5, in according the original paper that validated the questionnaire. Higher scores mean a worse perception.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of children: questionnaire</measure>
    <time_frame>After 6 months</time_frame>
    <description>Children-reported satisfaction regarding the treatment by a questionnaire with five question which for answers will be used a Face image scale (FIS). The scale present 5 different faces since &quot;very happy&quot; (scored as 1) until &quot;very sad&quot; (scored as 5) with the treatment. Lower scores mean a better satisfaction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">148</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Non-restorative cavity control - NRCC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enlargement with metallic sandpaper associated with toothbrushing/1000 ppm fluoride toothpaste.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resin composite restoration - RCR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Selective carious lesion removal and restoration with resin composite.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-restorative cavity control - NRCC group</intervention_name>
    <description>The proximal cavities will be enlarged with metallic sandpaper, exposing the cavity, to allow access for toothbrushing associated with 1000 ppm fluoride toothpaste.</description>
    <arm_group_label>Non-restorative cavity control - NRCC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Restoration with resin composite - RCR group</intervention_name>
    <description>In control group, the treatment will be performed after prophylaxis and relative isolation. The selective carious tissue removal will be performed with appropriate dentin curettes. The acid conditioning will be performed only in enamel for 15 s with 37% phosphoric acid gel, and then the application of the adhesive system and restoration of resin composite will be conducted.</description>
    <arm_group_label>Resin composite restoration - RCR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children will be included that have at least one anterior tooth with carious lesion&#xD;
             cavitated affecting the proximal surface.&#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 lesions affecting more than one third of the buccal/lingual surfaces,&#xD;
             with previous history of dental trauma, presenting pulp exposure, spontaneous pain,&#xD;
             pathological mobility, presence of abscess or fistula next to the tooth, teeth with&#xD;
             restorations, developmental enamel defects or physiological mobility (exfoliation)&#xD;
             will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>6 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>04.545-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2023</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 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</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/NCT03785730
org study id: Unib3
nct id: NCT03785730
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: Studies have questioned the necessity of restoring cavitated carious lesion on
      primary teeth, once the control of biofilm is the most important factor to arrest these
      lesions. This randomized clinical trial aimed to compare the survival of teeth treated with a
      non-restorative cavity control (NRCC) compared to resin composite restorations (RCR) on
      proximal carious lesion in anterior primary teeth, as well as the impact of these treatments
      on patient-centered outcomes. Methods: A randomized clinical trial with two parallels arms
      (1:1) will be conducted. Children between 3 and 6 years old will be selected from the Center
      of Clinic Research of Pediatric Dentistry of Ibirapuera University (UNIB), a dental trailer
      (FOUSP) located on Educational Complex Professor Carlos Osmarinho de Lima, the Pediatric
      Dentistry Clinic of Santa Cecília University and from the Pediatric Dentistry Clinic of
      University Center UNINOVAFAPI. One hundred and forty-eight teeth will be randomly distributed
      in two experimental groups: (1) Selective removal of carious tissue and RCR; or (2) NRCC
      through cavity enlargement using metallic sandpaper. The primary outcome will be tooth
      survival after 6, 12, 18, and 24 months. The duration and the cost of dental treatments will
      be considered for the estimation of the cost-effectiveness of the evaluated treatments. The
      discomfort reported by the participants will be measured after each treatment using the FIS
      scale. The participants' satisfaction and perception of the parents/legal guardians will be
      evaluated through questionnaires. For the primary outcome, Kaplan-Meier's survival and
      Long-Rank test will be used for comparison between the two groups. All the variables will be
      modeled by Cox regression with shared fragility. Significance will be considered at 5%.
This non-inferiority randomized controlled clinical trial, with two parallel groups with 1:1
      allocation ratio, was approved by the Research Ethics Committee of Universidade Ibirapuera
      (UNIB). The other centers involved are considered co-participants (Centro Universitário do
      Norte - Uninorte , Centro Universitário Uninovafapi - UNINOVAFAPI, and School of Dentistry
      from the University of Sao Paulo - FOUSP). Children aged 3 to 6 years with at least one
      proximal cavitated lesion on anterior primary teeth will be selected from the Clinical
      Pediatric Research Center. Teeth will be randomly allocated to selective removal of carious
      tissue and resin composite restoration (RCR) or NRCC. Tooth survival after two years of
      follow-up will be the primary outcome and cost-effectiveness, satisfaction, and discomfort
      reported by participants and parents/guardians' perception will be the secondary outcomes.
      Only patients who fulfill the eligibility criteria will be included in the study after the
      legal guardians sign the informed consent form and the child consents to participate in the
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tooth survival by clinical assessment
time frame: 24 months
description: Comparing the survival of teeth treated with restoration of resin composite and with NRCC for lesions cavitated in anterior primary teeth by clinical assessment, considering as success when the teeth will be without clinical signs or symptoms of pulp pathology or exfoliated, with no need for more invasive interventions, such as pulpectomy or extraction.
measure: Discomfort regarding the treatment options by a Face image scale (FIS)
time frame: Immediately after treatment
description: Children-reported discomfort regarding the treatment options by a Face image scale (FIS). The scale present 5 different faces since "very happy" (scored as 1) until "very sad" (scored as 5) with the treatment. Higher scores mean a worse discomfort.
measure: Cost-effectiveness analysis
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/effectiveness, being effectiveness considered the tooth survival.
measure: Perception of parents / guardians evaluated through questionnaire
time frame: Prior to treatment, immediately after and 6 months later.
description: Parents perception of the treatments will be evaluated through a questionnaire - "Child's and parent's questionnaire about teeth appearance" - with possible answers varying from very satisfied until insatisfied. After the questionnaire is applied for the parents/guardians, the anwsers will bem transformed in scores 1 to 5, in according the original paper that validated the questionnaire. Higher scores mean a worse perception.
measure: Satisfaction of children: questionnaire
time frame: After 6 months
description: Children-reported satisfaction regarding the treatment by a questionnaire with five question which for answers will be used a Face image scale (FIS). The scale present 5 different faces since "very happy" (scored as 1) until "very sad" (scored as 5) with the treatment. Lower scores mean a better satisfaction.
arm group label: Non-restorative cavity control - NRCC
arm group type: Experimental
description: Enlargement with metallic sandpaper associated with toothbrushing/1000 ppm fluoride toothpaste.
arm group label: Resin composite restoration - RCR
arm group type: Active Comparator
description: Selective carious lesion removal and restoration with resin composite.
intervention type: Procedure
intervention name: Non-restorative cavity control - NRCC group
description: The proximal cavities will be enlarged with metallic sandpaper, exposing the cavity, to allow access for toothbrushing associated with 1000 ppm fluoride toothpaste.
arm group label: Non-restorative cavity control - NRCC
intervention type: Procedure
intervention name: Restoration with resin composite - RCR group
description: In control group, the treatment will be performed after prophylaxis and relative isolation. The selective carious tissue removal will be performed with appropriate dentin curettes. The acid conditioning will be performed only in enamel for 15 s with 37% phosphoric acid gel, and then the application of the adhesive system and restoration of resin composite will be conducted.
arm group label: Resin composite restoration - RCR
criteria: 
gender: All
minimum age: 3 Years
maximum age: 6 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.