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/NCT05970965</url>
    </required_header>
    <id_info>
      <org_study_id>APHP230786</org_study_id>
      <nct_id>NCT05970965</nct_id>
    </id_info>
    <brief_title>Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples</brief_title>
    <acronym>NT21</acronym>
    <official_title>Study of Neutrophils During Gingival Inflammation in Children With Down Syndrome/Trisomy 21</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</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>
        Since 2018, the Chicago Classification of Periodontal Diseases and Conditions, has listed&#xD;
        Down syndrome (DS)/trisomy 21 (T21) as a systemic disease with periodontal implications.&#xD;
        Numerous studies report an increased prevalence and severity of periodontitis in DS/T21&#xD;
        individuals under the age of 35. Approximately 35% of adolescents with DS show early signs of&#xD;
        alveolar bone loss. However, very few studies have examined the role of immune deficiency in&#xD;
        DS/T21 patients in the pathogenesis of periodontitis. Indeed, periodontitis induced by&#xD;
        bacterial plaque is virtually non-existent in the paediatric population, leaving the field to&#xD;
        systemically-induced periodontitis.&#xD;
  &#xD;
        The investigators hypothesize that specific neutrophil phenotypes in DS/T21 patients are key&#xD;
        to explaining the rapid progression to periodontitis.&#xD;
  &#xD;
        Investigator's primary objective is to characterize the different oral and blood neutrophil&#xD;
        subtypes in DS/T21 children with gingival inflammation.&#xD;
  &#xD;
        Investigator's secondary objective is to assess the involvement of different neutrophil&#xD;
        subtypes in early periodontitis in children with DS/T21.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It's a cross-sectional, monocenter, prospective, open-label, non-randomized case control&#xD;
        study to collect saliva and serum samples as part of the patient's routine care in oral&#xD;
        medicine department to form a biological collection.&#xD;
  &#xD;
        Patients will be recruited in the oral medicine department of AP-HP Charles Foix hospital&#xD;
        (Ivry/Seine) by periodontists in 2 groups (CASES: Group 1 for children with DS/T21 divided&#xD;
        into 2 subgroups according the periodontal health, and CONTROLS: Group 2 divided into 4&#xD;
        subgroups according to the systemic and periodontal health) Inclusion period is 12 months.&#xD;
        There is no specific follow-up due to the research.&#xD;
  &#xD;
        Assessment criteria:&#xD;
  &#xD;
          -  Primary criteria: Neutrophil subtypes analysis based on co-expression of neutrophil&#xD;
             function markers from a panel of 24 markers by flow cytometry.&#xD;
  &#xD;
          -  Secondary criteria: assessment of neutrophil sub-types present in the patient's saliva&#xD;
             and study of the correlation within blood neutrophils, during periodontal health,&#xD;
             gingivitis and periodontitis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 13, 2023</start_date>
    <completion_date type="Anticipated">September 13, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 13, 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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry</measure>
      <time_frame>1 year</time_frame>
      <description>purification od neutrophils from blood and saliva Fixation Cell sorting using FACS on a panel of 24 markers</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluation of neutrophil subtypes present in saliva and study of a correlation with blood neutrophils during periodontal health and periodontal inflammation (intra individual analysis)</measure>
      <time_frame>1 year</time_frame>
      <description>Correlation with previous results</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Periodontitis</condition>
    <condition>Trisomy 21</condition>
    <arm_group>
      <arm_group_label>Child patient consulting the service</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Trisomy 21 patient with gingival inflammation (subgroup 1)&#xD;
  Trisomy 21 patient with healthy gingiva on intact periodontium with no history of periodontitis (subgroup 2)&#xD;
  Patient with psychomotor retardation with no known repercussions on the orofacial sphere or immunity, presenting gingival inflammation (subgroup 1)&#xD;
  Patients with psychomotor retardation and no known repercussions on orofacial health or immunity, presenting gingival health on intact periodontium with no history of gingival inflammation (subgroup 2).&#xD;
  Patients with no known general pathology and gingival inflammation (subgroup 3)&#xD;
  Patients with no known general pathology and healthy gingiva on intact periodontium with no history of gingival inflammation (subgroup 4)</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Biological sampling</intervention_name>
      <description>- Saliva and blood sampling</description>
      <arm_group_label>Child patient consulting the service</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Common to all groups:&#xD;
  &#xD;
            -  Age: 3 to 12&#xD;
  &#xD;
            -  Patient affiliated to a social security program, beneficiary not covered by the AME.&#xD;
  &#xD;
            -  Legal representatives who speak and understand French well enough to be able to read&#xD;
               and understand the study information.&#xD;
  &#xD;
            -  Legal representatives giving written consent for their child's participation in the&#xD;
               study.&#xD;
  &#xD;
          Specific:&#xD;
  &#xD;
          Case Group:&#xD;
  &#xD;
            -  Trisomy 21 patient with gingival inflammation (subgroup 1)&#xD;
  &#xD;
            -  Trisomy 21 patient with healthy gingiva on intact periodontium with no history of&#xD;
               periodontitis (subgroup 2)&#xD;
  &#xD;
          Control Group: child meeting one of these criteria:&#xD;
  &#xD;
            -  Patient with psychomotor retardation with no known repercussions on the orofacial&#xD;
               sphere or immunity, presenting gingival inflammation (subgroup 1)&#xD;
  &#xD;
            -  Patients with psychomotor retardation and no known repercussions on orofacial health&#xD;
               or immunity, presenting gingival health on intact periodontium with no history of&#xD;
               gingival inflammation (subgroup 2).&#xD;
  &#xD;
            -  Patients with no known general pathology and gingival inflammation (subgroup 3)&#xD;
  &#xD;
            -  Patients with no known general pathology and healthy gingiva on intact periodontium&#xD;
               with no history of gingival inflammation (subgroup 4)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Common to all groups:&#xD;
  &#xD;
            -  Patient having received antibiotic prophylaxis, antibiotic therapy or&#xD;
               anti-inflammatory treatment in the 3 months prior to inclusion&#xD;
  &#xD;
            -  Patient included in another interventional research protocol or in a period of&#xD;
               exclusion.&#xD;
  &#xD;
            -  Patient on AME&#xD;
  &#xD;
            -  Patients with a contraindication to the use of MEOPA:&#xD;
  &#xD;
                 -  Patients requiring pure oxygen ventilation&#xD;
  &#xD;
                 -  Intracranial hypertension&#xD;
  &#xD;
                 -  Unevaluated head trauma&#xD;
  &#xD;
                 -  New-onset, unexplained neurological abnormalities&#xD;
  &#xD;
                 -  Pneumothorax&#xD;
  &#xD;
                 -  Emphysema bubbles&#xD;
  &#xD;
                 -  Gas embolism&#xD;
  &#xD;
                 -  Diving accident&#xD;
  &#xD;
                 -  Abdominal gas distension, occlusion&#xD;
  &#xD;
                 -  Patient recently treated with ophthalmic gas (SF6, C3F8, C2F6)&#xD;
  &#xD;
                 -  Known, unsubstituted vitamin B12 deficiency&#xD;
  &#xD;
          Specific to Trisomy 21 group:&#xD;
  &#xD;
          - Patient with no genetic diagnosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marjolaine Ms GOSSET, PU-PH</last_name>
      <role>Principal Investigator</role>
      <affiliation>APHP</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marjolaine Ms GOSSET, PU-PH</last_name>
      <phone>0149594811</phone>
      <email>marjolaine.gosset@aphp.fr; marjolaine.gosset@u-paris.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anne Laure Ms BONNET, MCU-PH</last_name>
      <phone>0149594811</phone>
      <email>anne-laure.bonnet@aphp.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Carles-Foix Hospital</name>
        <address>
          <city>Ivry-sur-Seine</city>
          <zip>94200</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Marjolaine Ms GOSSET, PU-PH</last_name>
        <phone>0149594811</phone>
        <email>marjolaine.gosset@u-paris.fr; marjolaine.gosset@aphp.fr</email>
      </contact>
      <contact_backup>
        <last_name>Anne Laure BONNET, MCU-PH</last_name>
        <phone>0149594811</phone>
        <email>anne-laure.bonnet@aphp.fr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 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>Down syndrome</keyword>
    <keyword>Trisomy 21</keyword>
    <keyword>psychomotor retardation</keyword>
    <keyword>gingivitis</keyword>
    <keyword>periodontitis</keyword>
    <keyword>neutrophils</keyword>
    <keyword>biological collection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontitis</mesh_term>
      <mesh_term>Down Syndrome</mesh_term>
      <mesh_term>Inflammation</mesh_term>
      <mesh_term>Trisomy</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/NCT05970965
  org study id: APHP230786
  nct id: NCT05970965
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Since 2018, the Chicago Classification of Periodontal Diseases and Conditions, has listed
        Down syndrome (DS)/trisomy 21 (T21) as a systemic disease with periodontal implications.
        Numerous studies report an increased prevalence and severity of periodontitis in DS/T21
        individuals under the age of 35. Approximately 35% of adolescents with DS show early signs of
        alveolar bone loss. However, very few studies have examined the role of immune deficiency in
        DS/T21 patients in the pathogenesis of periodontitis. Indeed, periodontitis induced by
        bacterial plaque is virtually non-existent in the paediatric population, leaving the field to
        systemically-induced periodontitis.
  
        The investigators hypothesize that specific neutrophil phenotypes in DS/T21 patients are key
        to explaining the rapid progression to periodontitis.
  
        Investigator's primary objective is to characterize the different oral and blood neutrophil
        subtypes in DS/T21 children with gingival inflammation.
  
        Investigator's secondary objective is to assess the involvement of different neutrophil
        subtypes in early periodontitis in children with DS/T21.
  It's a cross-sectional, monocenter, prospective, open-label, non-randomized case control
        study to collect saliva and serum samples as part of the patient's routine care in oral
        medicine department to form a biological collection.
  
        Patients will be recruited in the oral medicine department of AP-HP Charles Foix hospital
        (Ivry/Seine) by periodontists in 2 groups (CASES: Group 1 for children with DS/T21 divided
        into 2 subgroups according the periodontal health, and CONTROLS: Group 2 divided into 4
        subgroups according to the systemic and periodontal health) Inclusion period is 12 months.
        There is no specific follow-up due to the research.
  
        Assessment criteria:
  
          -  Primary criteria: Neutrophil subtypes analysis based on co-expression of neutrophil
             function markers from a panel of 24 markers by flow cytometry.
  
          -  Secondary criteria: assessment of neutrophil sub-types present in the patient's saliva
             and study of the correlation within blood neutrophils, during periodontal health,
             gingivitis and periodontitis.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Distinction of neutrophil subtypes according to co-expression of markers of neutrophil function among a panel of 24 markers by flow cytometry
  time frame: 1 year
  description: purification od neutrophils from blood and saliva Fixation Cell sorting using FACS on a panel of 24 markers
  measure: Evaluation of neutrophil subtypes present in saliva and study of a correlation with blood neutrophils during periodontal health and periodontal inflammation (intra individual analysis)
  time frame: 1 year
  description: Correlation with previous results
  arm group label: Child patient consulting the service
  arm group type: Experimental
  description: Trisomy 21 patient with gingival inflammation (subgroup 1)
  Trisomy 21 patient with healthy gingiva on intact periodontium with no history of periodontitis (subgroup 2)
  Patient with psychomotor retardation with no known repercussions on the orofacial sphere or immunity, presenting gingival inflammation (subgroup 1)
  Patients with psychomotor retardation and no known repercussions on orofacial health or immunity, presenting gingival health on intact periodontium with no history of gingival inflammation (subgroup 2).
  Patients with no known general pathology and gingival inflammation (subgroup 3)
  Patients with no known general pathology and healthy gingiva on intact periodontium with no history of gingival inflammation (subgroup 4)
  intervention type: Procedure
  intervention name: Biological sampling
  description: - Saliva and blood sampling
  arm group label: Child patient consulting the service
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Marjolaine Ms GOSSET, PU-PH
  role: Principal Investigator
  affiliation: APHP
  last name: Marjolaine Ms GOSSET, PU-PH
  phone: 0149594811
  email: marjolaine.gosset@aphp.fr; marjolaine.gosset@u-paris.fr
  last name: Anne Laure Ms BONNET, MCU-PH
  phone: 0149594811
  email: anne-laure.bonnet@aphp.fr
  facility: 
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor
  mesh term: Periodontitis
  mesh term: Down Syndrome
  mesh term: Inflammation
  mesh term: Trisomy