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/NCT06006429</url>
    </required_header>
    <id_info>
      <org_study_id>PO21146</org_study_id>
      <nct_id>NCT06006429</nct_id>
    </id_info>
    <brief_title>Intraoral Scanners as Periodontal and Dental Pathologies Diagnosis Tools</brief_title>
    <acronym>Odonto3D</acronym>
    <official_title>Digital Extraction and Scientific Visualization of Clinical Characteristics From 3D Data From Intraoral Scanners for Dental and Periodontal Pathologies Research : Computer Formalization and Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CHU de Reims</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CHU de Reims</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>
        Periodontal diseases and dental pathologies are highly prevalent oral diseases. Thirty-three&#xD;
        to fifty percent of adult population presented at least one untreated caries and more than&#xD;
        50% of French population are affected by severe periodontitis. These diseases affect dental&#xD;
        organ or periodontal attached system but could have negative impact on general health,&#xD;
        quality of life, word and individual well-being. Association between chronic diseases as&#xD;
        diabetes, rheumatoid arthritis, cardiovascular diseases, and oral health have been well&#xD;
        investigated. Dental and periodontal diagnosis is dependent of various clinical parameters&#xD;
        time consuming and dependent operator. It represents a public health challenge. Informatic&#xD;
        analysis detecting diseases could be a time gain and a more precise diagnosis tool. Today,&#xD;
        any software or algorithm allow automatized detection, clinical qualitative or quantitative&#xD;
        indices recording while these informations are present in numeric models&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The present study explores the effectiveness of intraoral scanners in the field of dental&#xD;
        caries and periodontal diseases diagnosis Patients presenting at least on recession are&#xD;
        recruited without randomization. A clinical examination is performed, and a 3D impression of&#xD;
        their mouth is obtained by intraoral scanners.&#xD;
  &#xD;
        We hypothesized that the 3D intra oral representations could improve oral diagnosis in&#xD;
        patients compared to clinical examination in term of time consummation and precision. In a&#xD;
        first time, this could be achieved by the comparison of the recession measurement obtained by&#xD;
        a clinical measure (Ramfjord, 1959) or obtained by artificial intelligence.&#xD;
  &#xD;
        The secondary objectives are :&#xD;
  &#xD;
          -  To compare clinical and numerical dento-prosthetic diagram&#xD;
  &#xD;
          -  To compare clinical and numerical plaque control record index (O'Leary et al., 1973)&#xD;
  &#xD;
          -  To compare clinical and numerical Decayed, Missed and Filled Teeth index (Klein and&#xD;
             Palmer, 1940)&#xD;
  &#xD;
          -  To compare clinical and numerical detection of mucosal lesions&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 11, 2022</start_date>
    <completion_date type="Anticipated">December 11, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 11, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recession measurement concordance (Ramfjord, 1959)</measure>
      <time_frame>Day 1</time_frame>
      <description>Recession depths is measured between the cementum-enamel junction and the edge of the marginal gingiva.&#xD;
  The clinical and numerical scored will be compared.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Dento-prosthetic diagram concordance</measure>
      <time_frame>Day 1</time_frame>
      <description>Recording the presence or absence of tooth The clinical and numerical scored will be compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plaque Control Record Concordance (O'Leary et al., 1972)</measure>
      <time_frame>Day 1</time_frame>
      <description>Plaque control record will be recorded on individual tooth surfaces (mesial, distal, facial, lingual).&#xD;
  PCR is calculated according the following formula :&#xD;
  PCR = (Number of faces with plaque / Total number of faces) x 100&#xD;
  The clinical and numerical scored will be compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gingival Index Concordance (Loe and Silness, 1963)</measure>
      <time_frame>Day 1</time_frame>
      <description>Gingival index is scored as described :&#xD;
  0 Normal gingival Natural coral pink gingival with no inflammation&#xD;
  Mild inflammation Slight changes in color, slight edema. No bleeding on probing&#xD;
  Moderate inflammation Redness, edema and glazing Bleeding under probing&#xD;
  Severe inflammation Marked redness and edema/ulceration Tendency to bleed spontaneously&#xD;
  The clinical and numerical scored will be compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Decayed, Missed and Filled Teeth Index (Klein and Palmer, 1940)</measure>
      <time_frame>Day 1</time_frame>
      <description>DMFT is the sum of decayed, missed due to caries and filled teech in the permanent teeth.&#xD;
  Third molars are excepted.&#xD;
  The clinical and numerical scored will be compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mucosal lesions detection</measure>
      <time_frame>Day 1</time_frame>
      <description>Presence or absence of mucosal lesions.&#xD;
  The clinical and numerical lesions will be compared.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Periodontitis</condition>
    <condition>Gingivitis</condition>
    <condition>Dental Caries</condition>
    <condition>Diagnosis</condition>
    <arm_group>
      <arm_group_label>Patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Numerical dental impression by intraoral scanner</intervention_name>
      <description>Intervention consists in an 3D intra oral representation of the oral cavity</description>
      <arm_group_label>Patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adultes&#xD;
  &#xD;
            -  consulting the Dental Care Service of the university hospital of Reims&#xD;
  &#xD;
            -  presenting at least one gingival recession&#xD;
  &#xD;
            -  presenting at least 10 pairs of opposing teeth&#xD;
  &#xD;
            -  speaking French&#xD;
  &#xD;
            -  who signed the informed consent form&#xD;
  &#xD;
            -  affiliated to the French Social Security system&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients presenting :&#xD;
  &#xD;
            -  pregnancy or breastfeeding&#xD;
  &#xD;
            -  orthodontic treatments&#xD;
  &#xD;
            -  patients under legal protection, trusteeship or guardianship&#xD;
  &#xD;
            -  unable to understand auto-questionnary&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Julien BRAUX</last_name>
      <phone>03 26 78 78 24</phone>
      <phone_ext>0033</phone_ext>
      <email>jbraux@chu-reims.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Damien JOLLY</name>
        <address>
          <city>Reims</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Julien BRAUX</last_name>
        <phone>03 26 78 78 24</phone>
        <phone_ext>0033</phone_ext>
        <email>jbraux@chu-reims.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Periodontal diseases</keyword>
    <keyword>Dental caries</keyword>
    <keyword>intra-oral camera</keyword>
    <keyword>diagnosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gingivitis</mesh_term>
      <mesh_term>Periodontitis</mesh_term>
      <mesh_term>Dental Caries</mesh_term>
      <mesh_term>Disease</mesh_term>
    </condition_browse>
    <!-- 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/NCT06006429
  org study id: PO21146
  nct id: NCT06006429
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Periodontal diseases and dental pathologies are highly prevalent oral diseases. Thirty-three
        to fifty percent of adult population presented at least one untreated caries and more than
        50% of French population are affected by severe periodontitis. These diseases affect dental
        organ or periodontal attached system but could have negative impact on general health,
        quality of life, word and individual well-being. Association between chronic diseases as
        diabetes, rheumatoid arthritis, cardiovascular diseases, and oral health have been well
        investigated. Dental and periodontal diagnosis is dependent of various clinical parameters
        time consuming and dependent operator. It represents a public health challenge. Informatic
        analysis detecting diseases could be a time gain and a more precise diagnosis tool. Today,
        any software or algorithm allow automatized detection, clinical qualitative or quantitative
        indices recording while these informations are present in numeric models
  The present study explores the effectiveness of intraoral scanners in the field of dental
        caries and periodontal diseases diagnosis Patients presenting at least on recession are
        recruited without randomization. A clinical examination is performed, and a 3D impression of
        their mouth is obtained by intraoral scanners.
  
        We hypothesized that the 3D intra oral representations could improve oral diagnosis in
        patients compared to clinical examination in term of time consummation and precision. In a
        first time, this could be achieved by the comparison of the recession measurement obtained by
        a clinical measure (Ramfjord, 1959) or obtained by artificial intelligence.
  
        The secondary objectives are :
  
          -  To compare clinical and numerical dento-prosthetic diagram
  
          -  To compare clinical and numerical plaque control record index (O'Leary et al., 1973)
  
          -  To compare clinical and numerical Decayed, Missed and Filled Teeth index (Klein and
             Palmer, 1940)
  
          -  To compare clinical and numerical detection of mucosal lesions
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Recession measurement concordance (Ramfjord, 1959)
  time frame: Day 1
  description: Recession depths is measured between the cementum-enamel junction and the edge of the marginal gingiva.
  The clinical and numerical scored will be compared.
  measure: Dento-prosthetic diagram concordance
  time frame: Day 1
  description: Recording the presence or absence of tooth The clinical and numerical scored will be compared.
  measure: Plaque Control Record Concordance (O'Leary et al., 1972)
  time frame: Day 1
  description: Plaque control record will be recorded on individual tooth surfaces (mesial, distal, facial, lingual).
  PCR is calculated according the following formula :
  PCR = (Number of faces with plaque / Total number of faces) x 100
  The clinical and numerical scored will be compared.
  measure: Gingival Index Concordance (Loe and Silness, 1963)
  time frame: Day 1
  description: Gingival index is scored as described :
  0 Normal gingival Natural coral pink gingival with no inflammation
  Mild inflammation Slight changes in color, slight edema. No bleeding on probing
  Moderate inflammation Redness, edema and glazing Bleeding under probing
  Severe inflammation Marked redness and edema/ulceration Tendency to bleed spontaneously
  The clinical and numerical scored will be compared.
  measure: Decayed, Missed and Filled Teeth Index (Klein and Palmer, 1940)
  time frame: Day 1
  description: DMFT is the sum of decayed, missed due to caries and filled teech in the permanent teeth.
  Third molars are excepted.
  The clinical and numerical scored will be compared.
  measure: Mucosal lesions detection
  time frame: Day 1
  description: Presence or absence of mucosal lesions.
  The clinical and numerical lesions will be compared.
  arm group label: Patients
  arm group type: Experimental
  intervention type: Other
  intervention name: Numerical dental impression by intraoral scanner
  description: Intervention consists in an 3D intra oral representation of the oral cavity
  arm group label: Patients
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Julien BRAUX
  phone: 03 26 78 78 24
  phone ext: 0033
  email: jbraux@chu-reims.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Gingivitis
  mesh term: Periodontitis
  mesh term: Dental Caries
  mesh term: Disease