<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/NCT04426604</url>
  </required_header>
  <id_info>
    <org_study_id>AMAI-CU-2020-06-07</org_study_id>
    <nct_id>NCT04426604</nct_id>
  </id_info>
  <brief_title>Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study</brief_title>
  <official_title>Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted to evaluate the clinical performance and validity of both&#xD;
      light-induced fluorescence intraoral camera and laser-induced fluorescence device in&#xD;
      comparison to visual-tactile assessment method in detection of secondary caries around&#xD;
      margins of resin composite restorations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each patient should have at least one resin composite restoration. The restoration will be&#xD;
      evaluated by all diagnostic methods. Each examiner will independently record the dental&#xD;
      findings using all methods, the visual- tactile assessment method and both fluorescent-aided&#xD;
      identification methods. The visual-tactile assessment method includes the use of mirror,&#xD;
      probe under good illumination condition, while the fluorescent-aided identification methods&#xD;
      will be performed by both light-induced fluorescence intraoral camera and laser-induced&#xD;
      fluorescence device. Then Diagnostic performance for caries detection was evaluated,&#xD;
      assessing the validity of each diagnostic method in diagnosing secondary caries around&#xD;
      margins of resin composite restorations&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The assessors will not be blind about the type of intervention/control assessment methods. However it will not be allowed amongst the examiners to exchange any information throughout the entire study period</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Validity of Fluorescence-based Devices versus Visual-tactile method</measure>
    <time_frame>Through study completion, an average of 5 months</time_frame>
    <description>Diagnostic performance for caries detection was evaluated, assessing the validity of each diagnostic method in diagnosing secondary caries around margins of resin composite restorations in terms of sensitivity and specificity.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Secondary Caries Around Resin Composite Restorations</condition>
  <arm_group>
    <arm_group_label>Light induced fluorescence intraoral camera</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Laser-induced fluorescence device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Visual-tactile assessment method according to FDI criteria</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Light induced fluorescence intraoral camera</intervention_name>
    <description>Each restoration margins will be assessed by Light induced fluorescence intraoral camera to assess its validity in diagnosing secondary caries around margins of resin composite restorations</description>
    <arm_group_label>Light induced fluorescence intraoral camera</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Laser-induced fluorescence device</intervention_name>
    <description>Each restoration margins will be assessed by Laser-induced fluorescence device to assess its validity in diagnosing secondary caries around margins of resin composite restorations</description>
    <arm_group_label>Laser-induced fluorescence device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Visual-tactile assessment method according to FDI criteria</intervention_name>
    <description>Each restoration margins will be assessed by visual-tactile assessment method which includes the use of mirror, probe under good illumination condition to assess its validity in diagnosing secondary caries around margins of resin composite restorations</description>
    <arm_group_label>Visual-tactile assessment method according to FDI criteria</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients should be over 18 years of age.&#xD;
&#xD;
          -  Patients should have an acceptable oral hygiene level.&#xD;
&#xD;
          -  Patients should have at least one resin composite restoration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a compromised medical history.&#xD;
&#xD;
          -  Patients with active severe periodontal disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Aya Mohamed Adly Ibrahim, Master's Degree</last_name>
    <phone>+201221528843</phone>
    <email>aya.mohamed@dentistry.cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shereen Hafez Ibrahim, Associate Professor (PhD)</last_name>
    <phone>+201099296591</phone>
    <email>shereen.hafez@dentistry.cu.edu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Dentistry, Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aya Mohamed Adly Ibrahim, Master's Degree</last_name>
      <phone>+201221528843</phone>
      <email>aya.mohamed@dentistry.cu.edu.eg</email>
    </contact>
    <contact_backup>
      <last_name>Shereen Hafez Ibrahim, Associate Professor (PhD)</last_name>
      <phone>+201099296591</phone>
      <email>shereen.hafez@dentistry.cu.edu.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 31, 2021</last_update_submitted>
  <last_update_submitted_qc>July 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Aya Mohamed Adly</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>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04426604
org study id: AMAI-CU-2020-06-07
nct id: NCT04426604
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will be conducted to evaluate the clinical performance and validity of both
      light-induced fluorescence intraoral camera and laser-induced fluorescence device in
      comparison to visual-tactile assessment method in detection of secondary caries around
      margins of resin composite restorations.
Each patient should have at least one resin composite restoration. The restoration will be
      evaluated by all diagnostic methods. Each examiner will independently record the dental
      findings using all methods, the visual- tactile assessment method and both fluorescent-aided
      identification methods. The visual-tactile assessment method includes the use of mirror,
      probe under good illumination condition, while the fluorescent-aided identification methods
      will be performed by both light-induced fluorescence intraoral camera and laser-induced
      fluorescence device. Then Diagnostic performance for caries detection was evaluated,
      assessing the validity of each diagnostic method in diagnosing secondary caries around
      margins of resin composite restorations
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
masking description: The assessors will not be blind about the type of intervention/control assessment methods. However it will not be allowed amongst the examiners to exchange any information throughout the entire study period
measure: Validity of Fluorescence-based Devices versus Visual-tactile method
time frame: Through study completion, an average of 5 months
description: Diagnostic performance for caries detection was evaluated, assessing the validity of each diagnostic method in diagnosing secondary caries around margins of resin composite restorations in terms of sensitivity and specificity.
arm group label: Light induced fluorescence intraoral camera
arm group type: Experimental
arm group label: Laser-induced fluorescence device
arm group type: Experimental
arm group label: Visual-tactile assessment method according to FDI criteria
arm group type: Active Comparator
intervention type: Diagnostic Test
intervention name: Light induced fluorescence intraoral camera
description: Each restoration margins will be assessed by Light induced fluorescence intraoral camera to assess its validity in diagnosing secondary caries around margins of resin composite restorations
arm group label: Light induced fluorescence intraoral camera
intervention type: Diagnostic Test
intervention name: Laser-induced fluorescence device
description: Each restoration margins will be assessed by Laser-induced fluorescence device to assess its validity in diagnosing secondary caries around margins of resin composite restorations
arm group label: Laser-induced fluorescence device
intervention type: Diagnostic Test
intervention name: Visual-tactile assessment method according to FDI criteria
description: Each restoration margins will be assessed by visual-tactile assessment method which includes the use of mirror, probe under good illumination condition to assess its validity in diagnosing secondary caries around margins of resin composite restorations
arm group label: Visual-tactile assessment method according to FDI criteria
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aya Mohamed Adly Ibrahim, Master's Degree
phone: +201221528843
email: aya.mohamed@dentistry.cu.edu.eg
last name: Shereen Hafez Ibrahim, Associate Professor (PhD)
phone: +201099296591
email: shereen.hafez@dentistry.cu.edu.eg
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Aya Mohamed Adly
investigator title: Principal Investigator
mesh term: Neoplasm Metastasis