<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/NCT04438252</url>
  </required_header>
  <id_info>
    <org_study_id>1711</org_study_id>
    <nct_id>NCT04438252</nct_id>
  </id_info>
  <brief_title>Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions</brief_title>
  <official_title>Evaluation of Reliability of Impedance Spectroscopy (CarieScan PRO) in Comparison With Digital Radiograph and ICDAS-II in Detection of Occlusal Carious Lesions: Diagnostic Accuracy Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the Clinical performance of alternating current&#xD;
      impedance spectroscopy (CarieScan PRO) in comparison with digital radiograph and ICDAS-II in&#xD;
      detection of occlusal carious lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The visual examination is routinely used for detecting caries in dental clinics and was also&#xD;
      used in recent studies comparing the efficacy of various visual aids. It has the benefit that&#xD;
      it is quick and easy to perform, does not need expensive equipment, and can be completed&#xD;
      without unnecessary radiation or fluorescence (Ismail, et al., 2007). In the current study,&#xD;
      ICDAS-II was set as &quot;gold standard&quot; due to validated relationship between its codes and the&#xD;
      histological depth of a carious lesion as in many other studies. In addition, several studies&#xD;
      have shown good reproducibility and accuracy of ICDAS-II for caries detection in permanent&#xD;
      teeth especially caries lesions in the outer half of the enamel (Gugnani, et al., 2010).&#xD;
      Bitewing radiographs are used to determine the depth of caries involvement. Most often,&#xD;
      bitewing examination is affiliated with the diagnosis of interproximal caries. It is strongly&#xD;
      recommended that these radiographs be used in the diagnosis of occlusal caries into dentin&#xD;
      (Pitts NB et al., 1991).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2021</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>Diagnostic</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dental Caries</measure>
    <time_frame>slow study completion in average of 1 year</time_frame>
    <description>primary occlusal caries</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">166</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Cariescan pro</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>device for early caries detection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICDAS II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Index for caries detection</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ICDAS II</intervention_name>
    <description>Index for caries detection</description>
    <arm_group_label>ICDAS II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CariScan Pro</intervention_name>
    <description>Device for early caries detection</description>
    <arm_group_label>Cariescan pro</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Digital Radiograpgy</intervention_name>
    <description>Device for digital x-ray imaging</description>
    <arm_group_label>Cariescan pro</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria of teeth:&#xD;
&#xD;
          -  Posterior teeth with dark shadow on occlusal surface.&#xD;
&#xD;
          -  Vital upper or lower posterior teeth with no signs of irreversible pulpitis.&#xD;
&#xD;
          -  Intact contact with opposing teeth.&#xD;
&#xD;
          -  Teeth with no previous restorations in other surfaces.&#xD;
&#xD;
        Exclusion criteria of the teeth:&#xD;
&#xD;
          -  Periapical pathology or signs of pulpal pathology.&#xD;
&#xD;
          -  Tooth hypersensitivity.&#xD;
&#xD;
          -  Possible prosthodontic restoration of teeth.&#xD;
&#xD;
          -  Heavy occlusion and occlusal contacts or history of bruxism.&#xD;
&#xD;
          -  Severe periodontal affection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olfat ElSayed Hassanien, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty Of Dentistry</name>
      <address>
        <city>Cairo</city>
        <zip>11553</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Amr Ramadan Abdelkader</investigator_full_name>
    <investigator_title>Assistant Lecturer</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>Undecided</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/NCT04438252
org study id: 1711
nct id: NCT04438252
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the Clinical performance of alternating current
      impedance spectroscopy (CarieScan PRO) in comparison with digital radiograph and ICDAS-II in
      detection of occlusal carious lesions.
The visual examination is routinely used for detecting caries in dental clinics and was also
      used in recent studies comparing the efficacy of various visual aids. It has the benefit that
      it is quick and easy to perform, does not need expensive equipment, and can be completed
      without unnecessary radiation or fluorescence (Ismail, et al., 2007). In the current study,
      ICDAS-II was set as "gold standard" due to validated relationship between its codes and the
      histological depth of a carious lesion as in many other studies. In addition, several studies
      have shown good reproducibility and accuracy of ICDAS-II for caries detection in permanent
      teeth especially caries lesions in the outer half of the enamel (Gugnani, et al., 2010).
      Bitewing radiographs are used to determine the depth of caries involvement. Most often,
      bitewing examination is affiliated with the diagnosis of interproximal caries. It is strongly
      recommended that these radiographs be used in the diagnosis of occlusal caries into dentin
      (Pitts NB et al., 1991).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Dental Caries
time frame: slow study completion in average of 1 year
description: primary occlusal caries
arm group label: Cariescan pro
arm group type: Experimental
description: device for early caries detection
arm group label: ICDAS II
arm group type: Experimental
description: Index for caries detection
intervention type: Diagnostic Test
intervention name: ICDAS II
description: Index for caries detection
arm group label: ICDAS II
intervention type: Device
intervention name: CariScan Pro
description: Device for early caries detection
arm group label: Cariescan pro
intervention type: Radiation
intervention name: Digital Radiograpgy
description: Device for digital x-ray imaging
arm group label: Cariescan pro
criteria: 
gender: All
minimum age: 15 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Olfat ElSayed Hassanien, Doctor
role: Study Director
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Amr Ramadan Abdelkader
investigator title: Assistant Lecturer
mesh term: Dental Caries
sharing ipd: Undecided