<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/NCT03038412</url>
  </required_header>
  <id_info>
    <org_study_id>DHZhejiangU1</org_study_id>
    <nct_id>NCT03038412</nct_id>
  </id_info>
  <brief_title>Clinical Assessment of Caries and Dental Plaque Based on Auto-fluorescence Imaging System</brief_title>
  <official_title>Clinical Detection and Quantification of Caries and Dental Plaque Based on Auto-fluorescence Imaging System: An Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hui Chen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Dental Hospital of Zhejiang University School of Medicine</source>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the applicability of auto-fluorescence imaging&#xD;
      system to detect and quantify caries and dental plaque. Participants were advised to rinse&#xD;
      their mouth with distilled water to exclude any chance of fluorescence from food debris. A&#xD;
      well trained physicist majored in optical spectroscopy captured auto-fluorescence images of&#xD;
      buccal aspects of two maxillary central incisors and occlusal aspects of four first molars&#xD;
      from each patient in a dark room. Then they chewed a disclosing agent to assess the Quigley&#xD;
      Hein plaque index modified by Turesky of each tooth. Furthermore, participants were also&#xD;
      required to brush their teeth for 3min, then International Caries Detection and Assessment&#xD;
      System（ICDAS）codes of relevant teeth to evaluate degrees of caries were recorded by an&#xD;
      experienced dentist using a mouth mirror and explorer. The Spearman rank correlation&#xD;
      coefficient between colorimetric parameters of fluorescence image and the plaque index and&#xD;
      ICDAS code were calculated to evaluate the sensitivity and specificity of auto-fluorescence&#xD;
      imaging system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Auto-fluorescence image assessment</measure>
    <time_frame>1 week after image collection</time_frame>
    <description>Colorimetric parameters of auto-fluorescence images of buccal aspects of two maxillary central incisors and occlusal aspects of four first molars from each patient were calculated to get the Percentage Plaque Index (PPI). PPI is defined as the ratio between area of dental plaque on teeth and the whole teeth area.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Quigley Hein plaque index modified by Turesky</measure>
    <time_frame>right after disclosing</time_frame>
    <description>After disclosing dental plaque, plaque index was evaluated as following scoring system:0 no plaque;&#xD;
separate flecks of plaque at the cervical margin of the margin of the tooth;&#xD;
a thin continuous band of plaque (up to 1 mm) at the cervical margin;&#xD;
a band of plaque wider than 1 mm but covering less than (1/3)rd of crown;&#xD;
plaque covering at least (1/3)rd but less than (2/3)rd of the crown;&#xD;
plaque covering (2/3)rd or more of the crown</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ICDAS scoring results</measure>
    <time_frame>right after oral detection</time_frame>
    <description>After brushing teeth, ICDAS codes were recorded by an experienced dentist using a mouth mirror and explorer:0 sound；&#xD;
first visual change in enamel;&#xD;
distinct visual change in enamel;&#xD;
localized enamel breakdown;&#xD;
underlying dentine shadow;&#xD;
distinct cavity with visible dentine;&#xD;
extensive cavity within visible dentine.</description>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Dental Caries (Diagnosis)</condition>
  <condition>Dental Plaque</condition>
  <condition>Optical Imaging</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consisted of 60 patients are from the Affiliated Stomatology Hospital&#xD;
        of Medical College, Zhejiang University. They have caries in their mouth and need to be&#xD;
        treated by dentists with filling cavity. Two maxillary central incisors and four first&#xD;
        molars exist in each patient.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects were required to:&#xD;
&#xD;
          -  1. have two maxillary central incisors and four first molars in mouth;&#xD;
&#xD;
          -  2. have caries in their mouth or have a high risk to get caries and need to be treated&#xD;
             by dentists ;&#xD;
&#xD;
          -  3. sign informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.two incisors and four first molars of participants ever received endodontics&#xD;
             treatment;&#xD;
&#xD;
          -  2. history of antibiotics, mouthwashes, or any periodontal treatment during the last 3&#xD;
             months;&#xD;
&#xD;
          -  3.with calculus and cementum exposed in tooth cervical;&#xD;
&#xD;
          -  4. active systemic disease;&#xD;
&#xD;
          -  5. physical or mental disability;&#xD;
&#xD;
          -  6. pregnant or lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>54 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hui Chen</last_name>
    <role>Study Chair</role>
    <affiliation>Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Dental Hospital of Zhejiang University School of Medicine</investigator_affiliation>
    <investigator_full_name>Hui Chen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
    <mesh_term>Dental Plaque</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/NCT03038412
org study id: DHZhejiangU1
nct id: NCT03038412
lead sponsor: 
The purpose of this study was to evaluate the applicability of auto-fluorescence imaging
      system to detect and quantify caries and dental plaque. Participants were advised to rinse
      their mouth with distilled water to exclude any chance of fluorescence from food debris. A
      well trained physicist majored in optical spectroscopy captured auto-fluorescence images of
      buccal aspects of two maxillary central incisors and occlusal aspects of four first molars
      from each patient in a dark room. Then they chewed a disclosing agent to assess the Quigley
      Hein plaque index modified by Turesky of each tooth. Furthermore, participants were also
      required to brush their teeth for 3min, then International Caries Detection and Assessment
      System（ICDAS）codes of relevant teeth to evaluate degrees of caries were recorded by an
      experienced dentist using a mouth mirror and explorer. The Spearman rank correlation
      coefficient between colorimetric parameters of fluorescence image and the plaque index and
      ICDAS code were calculated to evaluate the sensitivity and specificity of auto-fluorescence
      imaging system.
observational model: Other
time perspective: Cross-Sectional
measure: Auto-fluorescence image assessment
time frame: 1 week after image collection
description: Colorimetric parameters of auto-fluorescence images of buccal aspects of two maxillary central incisors and occlusal aspects of four first molars from each patient were calculated to get the Percentage Plaque Index (PPI). PPI is defined as the ratio between area of dental plaque on teeth and the whole teeth area.
measure: The Quigley Hein plaque index modified by Turesky
time frame: right after disclosing
description: After disclosing dental plaque, plaque index was evaluated as following scoring system:0 no plaque;
separate flecks of plaque at the cervical margin of the margin of the tooth;
a thin continuous band of plaque (up to 1 mm) at the cervical margin;
a band of plaque wider than 1 mm but covering less than (1/3)rd of crown;
plaque covering at least (1/3)rd but less than (2/3)rd of the crown;
plaque covering (2/3)rd or more of the crown
measure: ICDAS scoring results
time frame: right after oral detection
description: After brushing teeth, ICDAS codes were recorded by an experienced dentist using a mouth mirror and explorer:0 sound；
first visual change in enamel;
distinct visual change in enamel;
localized enamel breakdown;
underlying dentine shadow;
distinct cavity with visible dentine;
extensive cavity within visible dentine.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 54 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hui Chen
role: Study Chair
affiliation: Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University
responsible party type: Sponsor-Investigator
investigator affiliation: The Dental Hospital of Zhejiang University School of Medicine
investigator full name: Hui Chen
investigator title: Professor
mesh term: Dental Caries
mesh term: Dental Plaque
sharing ipd: Undecided