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/NCT06016023</url>
    </required_header>
    <id_info>
      <org_study_id>RINDAPERIO2023</org_study_id>
      <nct_id>NCT06016023</nct_id>
    </id_info>
    <brief_title>Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker</brief_title>
    <official_title>Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker in Oral Rinse: A Cross Sectional Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Postgraduate Institute of Dental Sciences Rohtak</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Postgraduate Institute of Dental Sciences Rohtak</source>
    <oversight_info>
      <has_dmc>No</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>
        Periodontal disease is a chronic progressive state of inflammation pertaining to supporting&#xD;
        tissues of the dentition that culminates in loss of the affected teeth. Currently, diagnosis&#xD;
        and monitoring of periodontal disease progression is accomplished by performing a full-mouth&#xD;
        clinical and radiological examination which is time-consuming and also requires elaborate&#xD;
        infrastructure and equipment, which are not always available. Limitations of the conventional&#xD;
        diagnostic techniques necessitate the development of point-of-care testing (POCT) which could&#xD;
        serve as a rapid, feasible and affordable screening tool for periodontal disease.MIP-1α is a&#xD;
        cysteine-cysteine (C-C) chemokine that is secreted by a variety of cells like macrophages,&#xD;
        fibroblasts, epithelial cells and endothelial cells. They principally serve to recruit&#xD;
        leukocytes like monocytes, T lymphocytes, natural killer cells, dendritic cells and&#xD;
        granulocytes to the site of inflammation. Hence, the current study has a two fold aim; first,&#xD;
        to determine the feasibility of MIP-1α as a periodontal disease biomarker; and second, to&#xD;
        correlate the value of MIP-1α obtained from oral rinse sample with the periodontal disease&#xD;
        severity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Periodontal disease is a chronic progressive state of inflammation pertaining to supporting&#xD;
        tissues of the dentition that culminates in loss of the affected teeth. The term broadly&#xD;
        covers both gingivitis (inflammation of the gingival connective tissue) and periodontitis&#xD;
        (loss of supporting alveolar bone as a consequence of sustained inflammatory load on the&#xD;
        supportive periodontal tissues). Currently, diagnosis and monitoring of periodontal disease&#xD;
        progression is accomplished by performing a full-mouth clinical and radiological examination&#xD;
        which is time-consuming and also requires elaborate infrastructure and equipment, which are&#xD;
        not always available. These limitations of the conventional diagnostic techniques necessitate&#xD;
        the development of point-of-care testing (POCT) which could serve as a rapid, feasible and&#xD;
        affordable screening tool for periodontal disease.&#xD;
  &#xD;
        Of late, chemokines have become the subject of interest for potential application as&#xD;
        biomarkers for periodontal screening. MIP-1α is a cysteine-cysteine (C-C) chemokine that is&#xD;
        secreted by a variety of cells like macrophages, fibroblasts, epithelial cells and&#xD;
        endothelial cells. They principally serve to recruit leukocytes like monocytes, T&#xD;
        lymphocytes, natural killer cells, dendritic cells and granulocytes to the site of&#xD;
        inflammation. The primary challenge faced by researchers in analysis of host derived oral&#xD;
        biomarkers in any sample fluid is the establishment of normal level of various biomarkers.&#xD;
        This problem arises as the biomarkers that are found at exaggerated levels in periodontal&#xD;
        inflammation are also detected in oral fluids in healthy periodontium but at a much lower&#xD;
        value.&#xD;
  &#xD;
        Hence, the current study has a two fold aim; first, to determine the feasibility of MIP-1α as&#xD;
        a periodontal disease biomarker; and second, to correlate the value of MIP-1α obtained from&#xD;
        oral rinse sample with the periodontal disease severity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluation of Macrophage Inflammatory Protein-1α (MIP-1α) level</measure>
      <time_frame>12-14 months</time_frame>
      <description>Evaluation of MIP-1α level in sample across 4 groups of systemically healthy individuals (periodontally healthy, generalized gingivitis, generalized stage I/II periodontitis, generalized stage III/IV periodontitis)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To correlate the MIP-1α levels with clinical periodontal parameters</measure>
      <time_frame>12-14 months</time_frame>
      <description>To correlate the MIP-1α levels with clinical periodontal parameters (Gingival Index, Clinical Attachment Loss, Bleeding On Probing, Probing Pocket Depth)</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Periodontitis Chronic Generalized Severe</condition>
    <condition>Gingivitis</condition>
    <condition>Inflammatory Response</condition>
    <arm_group>
      <arm_group_label>Group 1: 30 periodontally healthy individuals.</arm_group_label>
      <description>Group 1 comprises of 30 periodontally healthy individuals who have never been clinically diagnosed with periodontitis.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2: 30 individuals with generalized gingivitis</arm_group_label>
      <description>Group 2 comprises of 30 participants diagnosed with generalized gingivitis according to the WWP 2017 classification.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3: 30 participants with generalised mild/moderate (STAGE I/II) periodontitis</arm_group_label>
      <description>Group 3 comprises of 30 participants, diagnosed with generalized mild/moderate (STAGE I/II) periodontitis, according to the WWP 2017 classification of periodontal disease.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 4: 30 participants with generalized severe/very severe (STAGE III/IV) periodontitis</arm_group_label>
      <description>Group 4 comprises of 30 participants, diagnosed with generalized severe/very severe (STAGE III/IV) periodontitis, according to WWP 2017 classification of periodontal disease.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will include consecutive subjects referred to the Department of&#xD;
          Periodontics, PGIDS, Rohtak. The patients will be screened according to the inclusion and&#xD;
          exclusion criteria for eligibility to participate in the study.&#xD;
  &#xD;
          The participants will comprise of the following groups :-&#xD;
  &#xD;
            1. Group 1: comprising of periodontally healthy individuals.&#xD;
  &#xD;
            2. Group 2: comprising of individuals, diagnosed with generalized gingivitis&#xD;
  &#xD;
            3. Group 3: comprising of participants, diagnosed with generalized mild/moderate (STAGE&#xD;
               I/II) periodontitis&#xD;
  &#xD;
            4. Group 4: comprising of participants, diagnosed with generalized severe/very severe&#xD;
               (STAGE III/IV) periodontitis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria: Presence of ≥ 20 natural teeth&#xD;
  &#xD;
            -  Ability and willingness to give written informed consent&#xD;
  &#xD;
            -  Patients belonging to 4 groups -periodontally healthy, generalized gingivitis,&#xD;
               generalized stage I/II periodontitis, generalized stage III/IV periodontitis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Patients with chronic inflammatory disease such as nephrotic syndrome, chronic renal&#xD;
               failure, significant cardiovascular disease, established type 1 or type 2 diabetes&#xD;
               mellitus, or active cancer within the past 5 years&#xD;
  &#xD;
                 -  Smokers and alcoholics&#xD;
  &#xD;
                 -  Pregnant females&#xD;
  &#xD;
                 -  Presence of xerostomia&#xD;
  &#xD;
                 -  Patients with oral lesions or other contact sensitivity&#xD;
  &#xD;
                 -  Patients suffering from autoimmune diseases such as Sjogren's syndrome,&#xD;
                    rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis&#xD;
  &#xD;
                 -  Patients with acute or chronic use of medications that cause oral dryness&#xD;
  &#xD;
                 -  Patients undergoing radiotherapy&#xD;
  &#xD;
                 -  Patients with Grade C periodontitis&#xD;
  &#xD;
                 -  Having received professional periodontal treatment within the previous 12 months&#xD;
  &#xD;
                 -  Having received antibiotic medication 3 months prior to study&#xD;
  &#xD;
                 -  Periapical pathology or other oral inflammatory conditions&#xD;
  &#xD;
                 -  Cognitive disability (interfering with ability to give samples)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>RINDA SHARMA, BDS</last_name>
      <role>Principal Investigator</role>
      <affiliation>PT. B. D. SHARMA UHSR HARYANA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ADITI SANGWAN, MDS</last_name>
      <phone>9996002408</phone>
      <email>aditidalal86@yahoo.co.in</email>
    </overall_contact>
    <location>
      <facility>
        <name>Post Graduate Institute of Dental Sciences</name>
        <address>
          <city>Rohtak</city>
          <state>Haryana</state>
          <zip>124001</zip>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>Periodontal Diseases</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/NCT06016023
  org study id: RINDAPERIO2023
  nct id: NCT06016023
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Periodontal disease is a chronic progressive state of inflammation pertaining to supporting
        tissues of the dentition that culminates in loss of the affected teeth. Currently, diagnosis
        and monitoring of periodontal disease progression is accomplished by performing a full-mouth
        clinical and radiological examination which is time-consuming and also requires elaborate
        infrastructure and equipment, which are not always available. Limitations of the conventional
        diagnostic techniques necessitate the development of point-of-care testing (POCT) which could
        serve as a rapid, feasible and affordable screening tool for periodontal disease.MIP-1α is a
        cysteine-cysteine (C-C) chemokine that is secreted by a variety of cells like macrophages,
        fibroblasts, epithelial cells and endothelial cells. They principally serve to recruit
        leukocytes like monocytes, T lymphocytes, natural killer cells, dendritic cells and
        granulocytes to the site of inflammation. Hence, the current study has a two fold aim; first,
        to determine the feasibility of MIP-1α as a periodontal disease biomarker; and second, to
        correlate the value of MIP-1α obtained from oral rinse sample with the periodontal disease
        severity.
  Periodontal disease is a chronic progressive state of inflammation pertaining to supporting
        tissues of the dentition that culminates in loss of the affected teeth. The term broadly
        covers both gingivitis (inflammation of the gingival connective tissue) and periodontitis
        (loss of supporting alveolar bone as a consequence of sustained inflammatory load on the
        supportive periodontal tissues). Currently, diagnosis and monitoring of periodontal disease
        progression is accomplished by performing a full-mouth clinical and radiological examination
        which is time-consuming and also requires elaborate infrastructure and equipment, which are
        not always available. These limitations of the conventional diagnostic techniques necessitate
        the development of point-of-care testing (POCT) which could serve as a rapid, feasible and
        affordable screening tool for periodontal disease.
  
        Of late, chemokines have become the subject of interest for potential application as
        biomarkers for periodontal screening. MIP-1α is a cysteine-cysteine (C-C) chemokine that is
        secreted by a variety of cells like macrophages, fibroblasts, epithelial cells and
        endothelial cells. They principally serve to recruit leukocytes like monocytes, T
        lymphocytes, natural killer cells, dendritic cells and granulocytes to the site of
        inflammation. The primary challenge faced by researchers in analysis of host derived oral
        biomarkers in any sample fluid is the establishment of normal level of various biomarkers.
        This problem arises as the biomarkers that are found at exaggerated levels in periodontal
        inflammation are also detected in oral fluids in healthy periodontium but at a much lower
        value.
  
        Hence, the current study has a two fold aim; first, to determine the feasibility of MIP-1α as
        a periodontal disease biomarker; and second, to correlate the value of MIP-1α obtained from
        oral rinse sample with the periodontal disease severity.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Evaluation of Macrophage Inflammatory Protein-1α (MIP-1α) level
  time frame: 12-14 months
  description: Evaluation of MIP-1α level in sample across 4 groups of systemically healthy individuals (periodontally healthy, generalized gingivitis, generalized stage I/II periodontitis, generalized stage III/IV periodontitis)
  measure: To correlate the MIP-1α levels with clinical periodontal parameters
  time frame: 12-14 months
  description: To correlate the MIP-1α levels with clinical periodontal parameters (Gingival Index, Clinical Attachment Loss, Bleeding On Probing, Probing Pocket Depth)
  arm group label: Group 1: 30 periodontally healthy individuals.
  description: Group 1 comprises of 30 periodontally healthy individuals who have never been clinically diagnosed with periodontitis.
  arm group label: Group 2: 30 individuals with generalized gingivitis
  description: Group 2 comprises of 30 participants diagnosed with generalized gingivitis according to the WWP 2017 classification.
  arm group label: Group 3: 30 participants with generalised mild/moderate (STAGE I/II) periodontitis
  description: Group 3 comprises of 30 participants, diagnosed with generalized mild/moderate (STAGE I/II) periodontitis, according to the WWP 2017 classification of periodontal disease.
  arm group label: Group 4: 30 participants with generalized severe/very severe (STAGE III/IV) periodontitis
  description: Group 4 comprises of 30 participants, diagnosed with generalized severe/very severe (STAGE III/IV) periodontitis, according to WWP 2017 classification of periodontal disease.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 65 Years
  last name: RINDA SHARMA, BDS
  role: Principal Investigator
  affiliation: PT. B. D. SHARMA UHSR HARYANA
  last name: ADITI SANGWAN, MDS
  phone: 9996002408
  email: aditidalal86@yahoo.co.in
  facility: 
  country: India
  responsible party type: Sponsor
  mesh term: Gingivitis
  mesh term: Periodontitis
  mesh term: Periodontal Diseases