xml: <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/NCT06019884</url>
    </required_header>
    <id_info>
      <org_study_id>#1-10/7/2023</org_study_id>
      <nct_id>NCT06019884</nct_id>
    </id_info>
    <brief_title>A Tele-detection and Referral Pathways Model for Early Childhood Caries Control</brief_title>
    <official_title>A Tele-detection and Referral Pathways Model for Early Childhood Caries Control: a Randomized Factorial Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Alexandria</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Alexandria</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 aim of the current study is to assess the effectiveness of different early childhood&#xD;
        caries (ECC) tele-detection methods combined with referral pathways with and without&#xD;
        preventive focus in controlling ECC based on clinically assessed and patient-reported oral&#xD;
        health outcomes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">January 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>Factorial Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The percentage of teeth receiving care</measure>
      <time_frame>up to 12 months</time_frame>
      <description>This will be assessed using the Caries Assessment Spectrum and Treatment (CAST) index. The CAST index hierarchically describes the full spectrum of caries from the absence of caries, passing through prevention (sealants) and treatment (restoration), to the presence of carious lesions with their complications (pulp exposure, abscess/fistula, and tooth loss). As for the condition severity, Codes 0-2 represent &quot;healthy&quot;, 3 indicates &quot;pre-morbidity&quot;, while 4-5 indicate &quot;morbidity&quot;, 6-7 indicate &quot;serious morbidity&quot;, and 8 indicates &quot;mortality&quot;.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Oral health-related quality of life</measure>
      <time_frame>up to 12 months</time_frame>
      <description>This will be assessedusing the Arabic Version of Early Childhood Oral Health Impact Scale (ECOHIS).The scale comprises 13 items included in two main sections: the Child Impact Section (9 items) and the Family Impact Section (4 items). The Child Impact Section has four domains: child symptom (one item), child function (four items), child psychology (two items) and child self-image and social interaction (two items). The Family Impact Scale has two domains: Parental distress (two items) and Family function (two items). The response options are coded: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = often; 4 = very often. ECOHIS scores are calculated by summing the response codes for the child and family sections separately. The values range from 0 to 52 for the total scale (0-36 for the child section and 0-16 for the family section). The highest score expressed a greater impact of the state of oral health indicating worse quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ability to detect early childhood caries cases at reversal or pre-morbidity levels</measure>
      <time_frame>up to 3 months</time_frame>
      <description>The clinical examination conducted at baseline to assess the ECC condition using CAST will be compared to CAST assessment of the two tele-detection methods to determine the diagnostic accuracy of the two tele-detection methods. Sensitivity, specificity, positive and negative predictive values will be calculated</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">868</enrollment>
    <condition>Early Childhood Caries</condition>
    <arm_group>
      <arm_group_label>Intraoral camera, no prevention specified</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Intraoral camera, prevention specified</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Smartphone camera, no prevention specified</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Smartphone camera, prevention specified</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Caries detection method: Intraoral camera</intervention_name>
      <description>A specialized intraoral camera (C50) with fluorescence signal and selective chromatic amplification will be used to record intraoral structures in the form of videos and/or photos. The camera has four modes (Daylight, Daylight+, Perio and Caries modes) which can differentiate the color of tissues to provide a reliable diagnosis. The camera will be used in a systemic sequence to video record and capture photos of intraoral conditions in both arches. The intraoral camera will be connected to a laptop screen, and the captured videos and/ or photos will be transferred to an electronic platform.</description>
      <arm_group_label>Intraoral camera, no prevention specified</arm_group_label>
      <arm_group_label>Intraoral camera, prevention specified</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Caries detection method: Smartphone camera</intervention_name>
      <description>This is a low-cost electronic system consisting of a smartphone positioned in front of the oral cavity to scan the upper and lower jaws from the cheek then the tongue sides. The smartphone camera resolution should be sensitive enough to capture the intraoral structures (at least 1000 pixels). The focus will be adjusted, and the inbuilt flash will be used to obtain clear and sharp images. The photos will be transferred to the electronic platform.</description>
      <arm_group_label>Smartphone camera, no prevention specified</arm_group_label>
      <arm_group_label>Smartphone camera, prevention specified</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Referral pathway: prevention specified</intervention_name>
      <description>Child identified at higher risk using the The International Caries Classification and Management System (ICCMS) classification due to the presence of caries experience will be referred with explicit inclusion of preventive care using professionally applied fluoride. The children will also be referred to restorative care or pulp therapy depending on their needs.</description>
      <arm_group_label>Intraoral camera, prevention specified</arm_group_label>
      <arm_group_label>Smartphone camera, prevention specified</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Referral pathway: no prevention specified</intervention_name>
      <description>This follows the standard practice adopted in dental clinics in public facilities. Care is planned by the receiving dentist, based on available resources, and hospital/ clinic policies. The screening/ sending dentist will inform the family of the oral health condition for which the child needs care and of available public and private facilities that offer this care. The management plan will not be predetermined, and decisions are left to the receiving dentists without explicit mention of the need for preventive care to control ECC.</description>
      <arm_group_label>Intraoral camera, no prevention specified</arm_group_label>
      <arm_group_label>Smartphone camera, no prevention specified</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;6 years old with primary dentition only.&#xD;
  &#xD;
            -  Written consent from the legal guardian&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children above 6 years old.&#xD;
  &#xD;
            -  Children with mixed or permanent dentitions.&#xD;
  &#xD;
            -  Children with physical disabilities or psychiatric disorders.&#xD;
  &#xD;
            -  Children with intellectual disabilities.&#xD;
  &#xD;
            -  Children indicated for dental treatment under general anesthesia&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>6 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nourhan M Aly, M.Sc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mona K El Kashlan, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nicolas Giraudeau</last_name>
      <role>Study Chair</role>
      <affiliation>University Hospital Center of Montpellier, France</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Maha El Tantawi, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nourhan M Aly, M.Sc</last_name>
      <phone>1006639489</phone>
      <phone_ext>+20</phone_ext>
      <email>nourhan.moustafa@alexu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of Dentistry, Alexandria University</name>
        <address>
          <city>Alexandria</city>
          <zip>21512</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Alexandria</investigator_affiliation>
      <investigator_full_name>Nourhan M.Aly</investigator_full_name>
      <investigator_title>Assistant Lecturer of Dental Public Health</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019884
  org study id: #1-10/7/2023
  nct id: NCT06019884
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the current study is to assess the effectiveness of different early childhood
        caries (ECC) tele-detection methods combined with referral pathways with and without
        preventive focus in controlling ECC based on clinically assessed and patient-reported oral
        health outcomes.
  allocation: Randomized
  intervention model: Factorial Assignment
  primary purpose: Diagnostic
  masking: Single (Outcomes Assessor)
  measure: The percentage of teeth receiving care
  time frame: up to 12 months
  description: This will be assessed using the Caries Assessment Spectrum and Treatment (CAST) index. The CAST index hierarchically describes the full spectrum of caries from the absence of caries, passing through prevention (sealants) and treatment (restoration), to the presence of carious lesions with their complications (pulp exposure, abscess/fistula, and tooth loss). As for the condition severity, Codes 0-2 represent "healthy", 3 indicates "pre-morbidity", while 4-5 indicate "morbidity", 6-7 indicate "serious morbidity", and 8 indicates "mortality".
  measure: Oral health-related quality of life
  time frame: up to 12 months
  description: This will be assessedusing the Arabic Version of Early Childhood Oral Health Impact Scale (ECOHIS).The scale comprises 13 items included in two main sections: the Child Impact Section (9 items) and the Family Impact Section (4 items). The Child Impact Section has four domains: child symptom (one item), child function (four items), child psychology (two items) and child self-image and social interaction (two items). The Family Impact Scale has two domains: Parental distress (two items) and Family function (two items). The response options are coded: 0 = never; 1 = hardly ever; 2 = occasionally; 3 = often; 4 = very often. ECOHIS scores are calculated by summing the response codes for the child and family sections separately. The values range from 0 to 52 for the total scale (0-36 for the child section and 0-16 for the family section). The highest score expressed a greater impact of the state of oral health indicating worse quality of life.
  measure: Ability to detect early childhood caries cases at reversal or pre-morbidity levels
  time frame: up to 3 months
  description: The clinical examination conducted at baseline to assess the ECC condition using CAST will be compared to CAST assessment of the two tele-detection methods to determine the diagnostic accuracy of the two tele-detection methods. Sensitivity, specificity, positive and negative predictive values will be calculated
  arm group label: Intraoral camera, no prevention specified
  arm group type: Experimental
  arm group label: Intraoral camera, prevention specified
  arm group type: Experimental
  arm group label: Smartphone camera, no prevention specified
  arm group type: Experimental
  arm group label: Smartphone camera, prevention specified
  arm group type: Experimental
  intervention type: Device
  intervention name: Caries detection method: Intraoral camera
  description: A specialized intraoral camera (C50) with fluorescence signal and selective chromatic amplification will be used to record intraoral structures in the form of videos and/or photos. The camera has four modes (Daylight, Daylight+, Perio and Caries modes) which can differentiate the color of tissues to provide a reliable diagnosis. The camera will be used in a systemic sequence to video record and capture photos of intraoral conditions in both arches. The intraoral camera will be connected to a laptop screen, and the captured videos and/ or photos will be transferred to an electronic platform.
  arm group label: Intraoral camera, no prevention specified
  arm group label: Intraoral camera, prevention specified
  intervention type: Device
  intervention name: Caries detection method: Smartphone camera
  description: This is a low-cost electronic system consisting of a smartphone positioned in front of the oral cavity to scan the upper and lower jaws from the cheek then the tongue sides. The smartphone camera resolution should be sensitive enough to capture the intraoral structures (at least 1000 pixels). The focus will be adjusted, and the inbuilt flash will be used to obtain clear and sharp images. The photos will be transferred to the electronic platform.
  arm group label: Smartphone camera, no prevention specified
  arm group label: Smartphone camera, prevention specified
  intervention type: Other
  intervention name: Referral pathway: prevention specified
  description: Child identified at higher risk using the The International Caries Classification and Management System (ICCMS) classification due to the presence of caries experience will be referred with explicit inclusion of preventive care using professionally applied fluoride. The children will also be referred to restorative care or pulp therapy depending on their needs.
  arm group label: Intraoral camera, prevention specified
  arm group label: Smartphone camera, prevention specified
  intervention type: Other
  intervention name: Referral pathway: no prevention specified
  description: This follows the standard practice adopted in dental clinics in public facilities. Care is planned by the receiving dentist, based on available resources, and hospital/ clinic policies. The screening/ sending dentist will inform the family of the oral health condition for which the child needs care and of available public and private facilities that offer this care. The management plan will not be predetermined, and decisions are left to the receiving dentists without explicit mention of the need for preventive care to control ECC.
  arm group label: Intraoral camera, no prevention specified
  arm group label: Smartphone camera, no prevention specified
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 6 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nourhan M Aly, M.Sc
  role: Principal Investigator
  affiliation: Alexandria University
  last name: Mona K El Kashlan, PhD
  role: Study Chair
  affiliation: Alexandria University
  last name: Nicolas Giraudeau
  role: Study Chair
  affiliation: University Hospital Center of Montpellier, France
  last name: Maha El Tantawi, PhD
  role: Study Director
  affiliation: Alexandria University
  last name: Nourhan M Aly, M.Sc
  phone: 1006639489
  phone ext: +20
  email: nourhan.moustafa@alexu.edu.eg
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: University of Alexandria
  investigator full name: Nourhan M.Aly
  investigator title: Assistant Lecturer of Dental Public Health