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/NCT06012019</url>
    </required_header>
    <id_info>
      <org_study_id>APHP230385</org_study_id>
      <nct_id>NCT06012019</nct_id>
    </id_info>
    <brief_title>Periodontitis and Inflammation: Study on Biological Samples</brief_title>
    <acronym>CB-PARO2</acronym>
    <official_title>Characterization of the Immuno-inflammatory Response Involved in Bone Destruction During Periodontitis: Study on Biological Samples With Collection</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>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Periodontitis is a major public health problem because it is widespread in the adult&#xD;
        population. It leads to the irreversible destruction of the anchoring tissues of the teeth,&#xD;
        and represents a modifiable risk factor for systemic inflammatory pathologies. This chronic&#xD;
        inflammatory disease, which is associated with oral dysbiosis involving Porphyromonas&#xD;
        gingivalis, is triggered by a permissive immune response. It is preceded by a reversible&#xD;
        clinical phase, during which there is no bone resorption process: gingivitis. The&#xD;
        understanding of the key mechanisms involved in the evolution from gingivitis to&#xD;
        periodontitis, which will allow to early identify patient at risk of periodontitis, remain&#xD;
        unclear at this time.&#xD;
  &#xD;
        Neutrophils are the main cells of inflammation present within the periodontal pockets. The&#xD;
        excess of certain neutrophils or the alteration of their functions is associated with the&#xD;
        triggering of periodontitis, whereas their activity, finely orchestrated, would be a key to&#xD;
        periodontal homeostasis. It is likely that some periodontal bacteria, including P.&#xD;
        gingivalis, but also products of matrix catabolism could deregulate the physiological&#xD;
        functions of neutrophils towards pro-inflammatory and catabolic profiles. Moreover, to date,&#xD;
        the differentiation and role of neutrophil subsets in periodontal homeostasis as well as in&#xD;
        gingivitis and its evolution into periodontitis remain poorly studied.&#xD;
  &#xD;
        The investigators hypothesize that various subsets of neutrophils may play different roles&#xD;
        during the development of periodontitis (evolution of gingivitis to periodontitis).&#xD;
  &#xD;
        The primary objective is to characterize neutrophil subtypes associated with periodontal&#xD;
        destruction during periodontitis.&#xD;
  &#xD;
        Secondary objectives are :&#xD;
  &#xD;
          1. Identify specific interactions of tissue-activated neutrophils with the matrix&#xD;
             microenvironment during periodontitis&#xD;
  &#xD;
          2. Identify specific interactions of tissue or oral (salivary) activated neutrophils with&#xD;
             the oral microbiota during periodontitis&#xD;
  &#xD;
          3. Identify specific oral (salivary) neutrophil subtypes in periodontal health, gingivitis&#xD;
             and periodontitis&#xD;
  &#xD;
          4. Evaluate the function, including pro-osteoclastogenic function, of oral neutrophils&#xD;
             compared to blood neutrophils stimulated by infection&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It's a cross-sectional, monocenter prospective, open-label, non randomized case control study&#xD;
        to collect tissue, crevicular, salivary, and serum samples as part of the patient's routine&#xD;
        care in oral medicine departments to form a biological collection. The samples and the&#xD;
        clinical data of the patients.&#xD;
  &#xD;
        Patients will be recruited in the oral medicine departments of AP-HP Charles Foix hospital&#xD;
        (Ivry/seine) by periodontists in three groups (Cases : Group 1 : Gingivitis, Group 2 :&#xD;
        Periodontitis, and Controls = healthy periodontium. All patients will require surgical care).&#xD;
  &#xD;
        The time-line of the research is consistent with the usual patient management in oral&#xD;
        medicine departments. Inclusion period is 36 months. There is no specific follow-up due to&#xD;
        the research. Gingival tissue sampling during surgery of patients will be performed after&#xD;
        their inclusion.&#xD;
  &#xD;
        Assessment Criteria :&#xD;
  &#xD;
          1. Neutrophil subtypes analysis based on co-expression of neutrophil function markers from&#xD;
             a panel of 24 markers by imaging on sections.&#xD;
  &#xD;
          2. Identification by immunohistofluorescence (on tissues) of the expression of matrix&#xD;
             proteins described as regulating neutrophil function, and search of co-location between&#xD;
             these proteins and certain neutrophil subtypes.&#xD;
  &#xD;
          3. Identification by immunohistofluorescence (on tissue) of key bacteria of oral dysbiosis&#xD;
             in periodontitis, and search for co-localization between these bacteria and certain&#xD;
             neutrophil subtypes.&#xD;
  &#xD;
          4. Assessment of neutrophil sub-types present in the patient's saliva and study of the&#xD;
             correlation within tissue neutrophils during periodontal health, gingivitis and&#xD;
             periodontitis.&#xD;
  &#xD;
          5. Differentiation and activity of osteoclasts in co-culture with isolated oral /blood&#xD;
             neutrophils in patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 6, 2023</start_date>
    <completion_date type="Anticipated">September 13, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 13, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Description of neutrophil subtypes associated with periodontal destruction in periodontitis based on coexpression of markers of neutrophil function .</measure>
      <time_frame>36 months</time_frame>
      <description>Distinction of neutrophil subtypes based on coexpression of markers of neutrophil function from a panel of 24 markers by imaging on tissue sections</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Identify specific interactions of activated tissue neutrophils with the matrix microenvironment during periodontitis using Immunohistofluorescence identification of the expression of some matrix proteins.</measure>
      <time_frame>36 months</time_frame>
      <description>Immunohistofluorescence identification (on tissue) of the expression of matrix proteins described as regulators of neutrophil function, and search for co-localization between said proteins/peptides and certain subtypes of neutrophils</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Identify interactions of activated tissue or oral neutrophils with the oral microbiota using Immunohistofluorescence identification of key bacteria and investigation of co-localization between bacteria and certain subtypes of neutrophils</measure>
      <time_frame>36 months</time_frame>
      <description>Immunohistofluorescence identification (on tissue) of key bacteria in oral dysbiosis during periodontitis and investigation of co-localization between bacteria and certain subtypes of neutrophils</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Describe oral (salivary) neutrophil subtypes during periodontal health, gingivitis and periodontitis based on coexpression of markers of neutrophil function.</measure>
      <time_frame>36 months</time_frame>
      <description>Evaluation of neutrophil subtypes present in patient saliva and study of correlation with tissue neutrophils during periodontal health, gingivitis and periodontitis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the differenciation, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection using morphological criteria like the number of nuclei and cell size</measure>
      <time_frame>36 months</time_frame>
      <description>osteoclast differentiation will be analyzed using morphological criteria, like the number of nuclei</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the differenciation, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection using morphological criteria like the cell size</measure>
      <time_frame>36 months</time_frame>
      <description>osteoclast differentiation will be analyzed using morphological criteria, like cell size</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the activity, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection, using functional criteria such as resorption activity (size of lacunae formed by the cells on culture dishes)</measure>
      <time_frame>36 months</time_frame>
      <description>Osteoclast activity will be assessed by functional criteria such as resorption activity (size of lacunae formed by the cells on specific culture dishes)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate the activity, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection, using functional criteria such as expression of activity markers by Trap staining</measure>
      <time_frame>36 months</time_frame>
      <description>Osteoclast activity will be assessed by functional criteria such as expression of activity markers (Trap staining)</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Periodontitis</condition>
    <arm_group>
      <arm_group_label>Periodontitis Cases</arm_group_label>
      <description>Patients with stage 3 or 4 periodontitis (Chicago 2017) ; BOP ≥ 10%, PD≥ 4mm Patients requiring surgical care such as dental avulsion or pre-prosthetic periodontal surgeries</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Gingivitis Cases</arm_group_label>
      <description>BOP ≥ 10%, PD≤ 3mm according to Chicago 2017 Patients requiring surgical care such as dental avulsion or pre-prosthetic periodontal surgeries</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <description>BOP &lt; 10%, PI &lt; 20%, PD≤ 3mm Patients with gingival health on intact or reduced periodontium without a history of periodontitis and requiring surgical care such as dental avulsion or aesthetic surgeries</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Biological sampling in Periodontitis Case</intervention_name>
      <description>Periodontal bacteria, gingival fluid, unstimulated saliva and blood collection;&#xD;
  J+7 : tooth extraction : gingival explant sampling&#xD;
  J+15 : Healing control</description>
      <arm_group_label>Periodontitis Cases</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Biological sampling in Gingivitis Case</intervention_name>
      <description>Periodontal bacteria, gingival fluid, unstimulated saliva and blood collection;&#xD;
  J+7 : tooth extraction or pre-prosthetic periodontal surgeries : gingival explant sampling&#xD;
  J+15 : Healing control</description>
      <arm_group_label>Gingivitis Cases</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Biological sampling in Control Case</intervention_name>
      <description>Periodontal bacteria, gingival fluid, unstimulated saliva and blood collection;&#xD;
  J+7 : tooth extraction or pre-prosthetic periodontal surgeries : gingival explant sampling&#xD;
  J+15 : Healing control</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        gingival tissue and fluid, saliva and serum samples&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          This study concerns adult patients consulting the oral medicine department at Hôpital&#xD;
          Charles Foix (AP-HP, Ivry sur Seine)&#xD;
  &#xD;
          Cases :&#xD;
  &#xD;
            -  Group 1 = Patients should have bacterial gingivitis&#xD;
  &#xD;
            -  Group 2 = Patients should have stage 3 or 4 localized or generalized bacterial&#xD;
               periodontitis.&#xD;
  &#xD;
          The diagnosis of gingivitis or periodontitis is based on the elements noted during the&#xD;
          clinical interview and examination, in accordance with the Chicago 2017 classification.&#xD;
  &#xD;
          Control:&#xD;
  &#xD;
          Patient with healthy gingiva on intact or reduced periodontium with no history of&#xD;
          periodontitis, in accordance with the Chicago 2017 classification.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Common criteria for all patient groups&#xD;
  &#xD;
            -  Patient &gt; 18 years old&#xD;
  &#xD;
            -  Patient affiliated to a national health insurance&#xD;
  &#xD;
            -  Patient who speaks and understands French well enough to be able to read and&#xD;
               understand the study information note.&#xD;
  &#xD;
            -  Patient who does not object to his participation in the study&#xD;
  &#xD;
          Specific Criteria :&#xD;
  &#xD;
            -  Control Group = BOP &lt; 10%, PI&lt;20%, PD≤ 3mm&#xD;
  &#xD;
            -  Gingivitis cases = BOP ≥ 10%, PD≤ 3mm&#xD;
  &#xD;
            -  Periodontitis cases = BOP ≥ 10%, PD&gt; 3mm&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have received antibiotic prophylaxis, antibiotic therapy, or&#xD;
               anti-inflammatory treatment within 3 months prior to inclusion&#xD;
  &#xD;
            -  Pregnant or breastfeeding women&#xD;
  &#xD;
            -  Patients suffering from a disease with defective neutrophil number, activity,&#xD;
               activation or function&#xD;
  &#xD;
            -  Patient deprived of liberty by judicial or administrative decision.&#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_official>
      <last_name>Marjolaine Gosset, PU-PH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marjolaine Gosset, PU-PH</last_name>
      <phone>01 49 59 48 11</phone>
      <email>marjolaine.gosset@u-paris.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>François Ferré, MCU-PH</last_name>
      <phone>01 49 59 48 11</phone>
      <email>françois.ferre@aphp.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Charles-Foix Hospital</name>
        <address>
          <city>Ivry-sur-Seine</city>
          <zip>94200</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Marjolaine Gosset, PU-PH</last_name>
        <phone>01 49 59 48 11</phone>
        <email>marjolaine.gosset@u-paris.fr</email>
      </contact>
      <contact_backup>
        <last_name>Sandrine Dos Santos</last_name>
        <phone>01 49 59 48 11</phone>
        <email>sandrine.dossantos2@aphp.fr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 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 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Periodontitis</keyword>
    <keyword>Gingivitis</keyword>
    <keyword>Neutrophils</keyword>
    <keyword>Subsets</keyword>
    <keyword>Biological collection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.&#xD;
  Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor</ipd_time_frame>
      <ipd_access_criteria>Researchers who provide a methodologically sound proposal</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT06012019
  org study id: APHP230385
  nct id: NCT06012019
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Periodontitis is a major public health problem because it is widespread in the adult
        population. It leads to the irreversible destruction of the anchoring tissues of the teeth,
        and represents a modifiable risk factor for systemic inflammatory pathologies. This chronic
        inflammatory disease, which is associated with oral dysbiosis involving Porphyromonas
        gingivalis, is triggered by a permissive immune response. It is preceded by a reversible
        clinical phase, during which there is no bone resorption process: gingivitis. The
        understanding of the key mechanisms involved in the evolution from gingivitis to
        periodontitis, which will allow to early identify patient at risk of periodontitis, remain
        unclear at this time.
  
        Neutrophils are the main cells of inflammation present within the periodontal pockets. The
        excess of certain neutrophils or the alteration of their functions is associated with the
        triggering of periodontitis, whereas their activity, finely orchestrated, would be a key to
        periodontal homeostasis. It is likely that some periodontal bacteria, including P.
        gingivalis, but also products of matrix catabolism could deregulate the physiological
        functions of neutrophils towards pro-inflammatory and catabolic profiles. Moreover, to date,
        the differentiation and role of neutrophil subsets in periodontal homeostasis as well as in
        gingivitis and its evolution into periodontitis remain poorly studied.
  
        The investigators hypothesize that various subsets of neutrophils may play different roles
        during the development of periodontitis (evolution of gingivitis to periodontitis).
  
        The primary objective is to characterize neutrophil subtypes associated with periodontal
        destruction during periodontitis.
  
        Secondary objectives are :
  
          1. Identify specific interactions of tissue-activated neutrophils with the matrix
             microenvironment during periodontitis
  
          2. Identify specific interactions of tissue or oral (salivary) activated neutrophils with
             the oral microbiota during periodontitis
  
          3. Identify specific oral (salivary) neutrophil subtypes in periodontal health, gingivitis
             and periodontitis
  
          4. Evaluate the function, including pro-osteoclastogenic function, of oral neutrophils
             compared to blood neutrophils stimulated by infection
  It's a cross-sectional, monocenter prospective, open-label, non randomized case control study
        to collect tissue, crevicular, salivary, and serum samples as part of the patient's routine
        care in oral medicine departments to form a biological collection. The samples and the
        clinical data of the patients.
  
        Patients will be recruited in the oral medicine departments of AP-HP Charles Foix hospital
        (Ivry/seine) by periodontists in three groups (Cases : Group 1 : Gingivitis, Group 2 :
        Periodontitis, and Controls = healthy periodontium. All patients will require surgical care).
  
        The time-line of the research is consistent with the usual patient management in oral
        medicine departments. Inclusion period is 36 months. There is no specific follow-up due to
        the research. Gingival tissue sampling during surgery of patients will be performed after
        their inclusion.
  
        Assessment Criteria :
  
          1. Neutrophil subtypes analysis based on co-expression of neutrophil function markers from
             a panel of 24 markers by imaging on sections.
  
          2. Identification by immunohistofluorescence (on tissues) of the expression of matrix
             proteins described as regulating neutrophil function, and search of co-location between
             these proteins and certain neutrophil subtypes.
  
          3. Identification by immunohistofluorescence (on tissue) of key bacteria of oral dysbiosis
             in periodontitis, and search for co-localization between these bacteria and certain
             neutrophil subtypes.
  
          4. Assessment of neutrophil sub-types present in the patient's saliva and study of the
             correlation within tissue neutrophils during periodontal health, gingivitis and
             periodontitis.
  
          5. Differentiation and activity of osteoclasts in co-culture with isolated oral /blood
             neutrophils in patients.
  observational model: Case-Control
  time perspective: Prospective
  measure: Description of neutrophil subtypes associated with periodontal destruction in periodontitis based on coexpression of markers of neutrophil function .
  time frame: 36 months
  description: Distinction of neutrophil subtypes based on coexpression of markers of neutrophil function from a panel of 24 markers by imaging on tissue sections
  measure: Identify specific interactions of activated tissue neutrophils with the matrix microenvironment during periodontitis using Immunohistofluorescence identification of the expression of some matrix proteins.
  time frame: 36 months
  description: Immunohistofluorescence identification (on tissue) of the expression of matrix proteins described as regulators of neutrophil function, and search for co-localization between said proteins/peptides and certain subtypes of neutrophils
  measure: Identify interactions of activated tissue or oral neutrophils with the oral microbiota using Immunohistofluorescence identification of key bacteria and investigation of co-localization between bacteria and certain subtypes of neutrophils
  time frame: 36 months
  description: Immunohistofluorescence identification (on tissue) of key bacteria in oral dysbiosis during periodontitis and investigation of co-localization between bacteria and certain subtypes of neutrophils
  measure: Describe oral (salivary) neutrophil subtypes during periodontal health, gingivitis and periodontitis based on coexpression of markers of neutrophil function.
  time frame: 36 months
  description: Evaluation of neutrophil subtypes present in patient saliva and study of correlation with tissue neutrophils during periodontal health, gingivitis and periodontitis
  measure: Evaluate the differenciation, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection using morphological criteria like the number of nuclei and cell size
  time frame: 36 months
  description: osteoclast differentiation will be analyzed using morphological criteria, like the number of nuclei
  measure: Evaluate the differenciation, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection using morphological criteria like the cell size
  time frame: 36 months
  description: osteoclast differentiation will be analyzed using morphological criteria, like cell size
  measure: Evaluate the activity, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection, using functional criteria such as resorption activity (size of lacunae formed by the cells on culture dishes)
  time frame: 36 months
  description: Osteoclast activity will be assessed by functional criteria such as resorption activity (size of lacunae formed by the cells on specific culture dishes)
  measure: Evaluate the activity, particularly proosteoclastogenic, of oral neutrophils, in comparison with blood neutrophils, stimulated by infection, using functional criteria such as expression of activity markers by Trap staining
  time frame: 36 months
  description: Osteoclast activity will be assessed by functional criteria such as expression of activity markers (Trap staining)
  arm group label: Periodontitis Cases
  description: Patients with stage 3 or 4 periodontitis (Chicago 2017) ; BOP ≥ 10%, PD≥ 4mm Patients requiring surgical care such as dental avulsion or pre-prosthetic periodontal surgeries
  arm group label: Gingivitis Cases
  description: BOP ≥ 10%, PD≤ 3mm according to Chicago 2017 Patients requiring surgical care such as dental avulsion or pre-prosthetic periodontal surgeries
  arm group label: Control
  description: BOP < 10%, PI < 20%, PD≤ 3mm Patients with gingival health on intact or reduced periodontium without a history of periodontitis and requiring surgical care such as dental avulsion or aesthetic surgeries
  intervention type: Other
  intervention name: Biological sampling in Periodontitis Case
  description: Periodontal bacteria, gingival fluid, unstimulated saliva and blood collection;
  J+7 : tooth extraction : gingival explant sampling
  J+15 : Healing control
  arm group label: Periodontitis Cases
  intervention type: Other
  intervention name: Biological sampling in Gingivitis Case
  description: Periodontal bacteria, gingival fluid, unstimulated saliva and blood collection;
  J+7 : tooth extraction or pre-prosthetic periodontal surgeries : gingival explant sampling
  J+15 : Healing control
  arm group label: Gingivitis Cases
  intervention type: Other
  intervention name: Biological sampling in Control Case
  description: Periodontal bacteria, gingival fluid, unstimulated saliva and blood collection;
  J+7 : tooth extraction or pre-prosthetic periodontal surgeries : gingival explant sampling
  J+15 : Healing control
  arm group label: Control
  gingival tissue and fluid, saliva and serum samples
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Marjolaine Gosset, PU-PH
  role: Principal Investigator
  affiliation: Assistance Publique - Hôpitaux de Paris
  last name: Marjolaine Gosset, PU-PH
  phone: 01 49 59 48 11
  email: marjolaine.gosset@u-paris.fr
  last name: François Ferré, MCU-PH
  phone: 01 49 59 48 11
  email: françois.ferre@aphp.fr
  facility: 
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor
  mesh term: Periodontitis
  sharing ipd: Yes
  ipd description: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
  Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
  ipd access criteria: Researchers who provide a methodologically sound proposal