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/NCT05962567</url>
    </required_header>
    <id_info>
      <org_study_id>FDASU-Rec IM112108</org_study_id>
      <nct_id>NCT05962567</nct_id>
    </id_info>
    <brief_title>Interleukin-34 Level in Periodontal Disease</brief_title>
    <official_title>Effect of Non-surgical Periodontal Therapy on Interleukin-34 Level in Gingival Crevicular Fluid in Patients With Periodontal Disease (Controlled Clinical Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</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>
        Aim of the study:&#xD;
  &#xD;
          1. To investigate changes in the levels of Interleukin 34 (IL-34) in the Gingival&#xD;
             crevicular fluid(GCF) of patients with stage II periodontitis patients before and after&#xD;
             nonsurgical periodontal therapy and compare it with healthy individuals&#xD;
  &#xD;
          2. To correlate changes in Gingival crevicular fluid level of Interleukin 34 with changes&#xD;
             in periodontal parameters after nonsurgical periodontal therapy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Periodontal disease is a chronic disease of various inflammatory diseases where the early&#xD;
        symptoms are gingival redness, swelling, and bleeding. As the disease progresses, periodontal&#xD;
        pockets, clinical attachment loss (CAL) as well as alveolar bone resorption may occur. If&#xD;
        left untreated, periodontal disease can lead to loss of teeth which directly affects&#xD;
        patient's mastication.&#xD;
  &#xD;
        A new system of periodontal classification has been adopted, in which the types of disease&#xD;
        that were previously identified as &quot;chronic&quot; or &quot;aggressive&quot; Armitage, 1999 are now&#xD;
        classified under one category (&quot;periodontitis&quot;) and re-diagnosed on the basis of many&#xD;
        variants (staging and grading system).&#xD;
  &#xD;
        The stage is based on the severity of the disease and the complexity of the disease&#xD;
        management (in terms of loss of clinical attachment between teeth (CAL), radiographic bone&#xD;
        loss, and tooth loss), complexity, and size and distribution. Grading provides additional&#xD;
        information about the biological features of the disease, including history-based analysis of&#xD;
        the progression rate of periodontitis; progression risk assessment; analysis of possible&#xD;
        adverse effects of treatment; and risk assessment that the disease or its treatment may&#xD;
        adversely affect the patient's normal life.&#xD;
  &#xD;
        Periodontitis is described in four stages ranging from Stage I: Initial periodontitis (CAL&#xD;
        1-2mm), Stage II: Moderate periodontitis (CAL 3-4 mm), Stage III: Severe periodontitis with&#xD;
        potential for additional tooth loss (&lt;4), and(CAL≥5mm) Stage IV: Severe periodontitis with&#xD;
        potential for loss of dentition (≥5) and (CAL≥5mm). Grading focuses on assessing risk factors&#xD;
        like smoking, diabetes, and outcomes of scaling and root debridement. Grade A: Slow rate of&#xD;
        progression (no CAL loss over 5 years), Grade B: Moderate rate of progression (CAL loss&lt;2mm&#xD;
        over 5years), and Grade C: Rapid rate of progression (CAL loss ≥2 mm over 5 years).&#xD;
  &#xD;
        Periodontitis occurs due to a complex of genetic, environmental, and bacterial interaction in&#xD;
        which bacterial and host factors play an important role. The imbalance between the previous&#xD;
        two factors results in a completely different change from health state to inflammatory&#xD;
        disease and once inflammation has begun, activation of many cytokines and molecular&#xD;
        mechanisms occur.&#xD;
  &#xD;
        Cytokines are defined as soluble small proteins (~5-20 kDa) which bind to specific receptors&#xD;
        on certain cells, stimulate some internal cellular changes, and cause multiple genetic and&#xD;
        chemical regulations. While molecular mechanisms activate the host-derived proteinase that&#xD;
        allow the loss of the marginal periodontal ligament fibers, the migration of the junctional&#xD;
        epithelium apically, and the proliferation of bacterial biofilm on the root surface.&#xD;
  &#xD;
        There are two different types of inflammatory cytokines: proinflammatory cytokines that is&#xD;
        involved in inflammatory reactions including IL-1β, IL-6, IL-12, TNF-α, and anti-inflammatory&#xD;
        cytokines that regulate or control the pro-inflammatory cytokine response including IL-4,&#xD;
        Interleukin-1 receptor antagonist (IL-1RA) and IL-10&#xD;
  &#xD;
        Scaling and root debridement (NSPT) aimed at mechanical removal of bacterial plaque from the&#xD;
        tooth surface is considered the &quot;gold standard.&quot; This procedure decreases the number of&#xD;
        Gram-negative bacteria in favor of Gram-positive bacteria as well as reduces the overall&#xD;
        number of microorganisms in periodontal pockets and decrease amount of proinflammatory&#xD;
        cytokines.&#xD;
  &#xD;
        Traditional clinical periodontal diagnostic parameters used include probing depths, bleeding&#xD;
        on probing, clinical attachment levels, plaque index, and radiographs assessing alveolar bone&#xD;
        level. They are limited, in that only disease history, not current disease status, can be&#xD;
        assessed.&#xD;
  &#xD;
        Recent methods in oral and periodontal disease diagnostic research are identifying&#xD;
        periodontal risk which is quantified by objective measures like biomarkers which are&#xD;
        diagnostic tools to measure periodontal disease at the molecular, cellular, tissue, and&#xD;
        clinical levels.&#xD;
  &#xD;
        There are many bone resorption biomarkers such as receptor activator nuclear factor kappa B&#xD;
        (RANKL), a tumor necrosis factor (TNF) family cytokine, as well as on macrophage&#xD;
        colony-stimulating factor (M-CSF) . M-CSF is required for osteoclastogenesis, stimulating&#xD;
        both adhesion and proliferation of osteoclast precursors. The novel cytokine interleukin 34&#xD;
        (IL-34) is the second active component of colony-stimulating factor receptor (CSF-1R). IL-34&#xD;
        was shown to stimulate monocyte activation and colonization of macrophages from bone marrow&#xD;
        cells.&#xD;
  &#xD;
        IL-34 messenger RNA (mRNA) is expressed in a number of tissues, including the heart, brain,&#xD;
        lungs, liver, kidneys, spleen, thymus, testes, ovary, small intestine, prostate, and colon,&#xD;
        as well as -spleen.&#xD;
  &#xD;
        IL-34 plays an important role in RANKL-induced osteoclastogenesis. Inhibition of the CSF-1&#xD;
        receptor by IL-34 has been shown to reduce alveolar bone loss in a periodontal rat model,&#xD;
        highlighting their role in periodontal pathology.&#xD;
  &#xD;
        The diagnostic potential of gingival crevicular fluid (GCF) has been evaluated from&#xD;
        confirming health and disease status to recent predictive tool. It distinguishes between&#xD;
        healthy sites of diseased individuals and healthy sites of periodontally healthy people in&#xD;
        the microbial profile and the concentration and formation of molecular biomarkers and&#xD;
        therefore predicts patient-or-site-based disease Study in 2018, reported that estimation of&#xD;
        IL-34 level detects high-risk individuals with periodontitis and systemic diseases, such as&#xD;
        diabetes as high levels of IL-34 in gingival crevicular fluid (GCF) and plasma of patients&#xD;
        with chronic periodontitis, further increased when accompanied with type 2 diabetes mellitus&#xD;
        (T2DM) IL-34 can be considered a potential inflammatory biomarker of periodontal disease as&#xD;
        GCF IL-34 levels was high in patients with periodontitis and decreased after NSPT.&#xD;
  &#xD;
        On the other hand, salivary levels of IL-34 were significantly lower in the periodontitis&#xD;
        group compared to both healthy groups and gingivitis. After receiving non-surgical&#xD;
        periodontal treatment at 3 and 6 months post-treatment, IL-34 significantly increased 3&#xD;
        months after treatment compared with baseline.&#xD;
  &#xD;
        Therefore, Further studies must be carried out to confirm these findings and to better&#xD;
        understand the possible role of IL-34 in the pathogenesis of periodontal diseases and to&#xD;
        evaluate its levels in GCF in patients with periodontal disease after non-surgical&#xD;
        periodontal treatment (NSPT)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Supra and subgingival scaling will be performed on all patients. Oral Hygiene measures will be instructed following treatment and follow up after 3 months</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>1- To measure the IL - 34 levels in ng/L in GCF before &amp;after Non-Surgical Periodontal Therapy of stage II periodontitis patients and compare it to healthy individuals</measure>
      <time_frame>3 months</time_frame>
      <description>1- To measure the IL - 34 levels in ng/L in GCF before &amp;after Non-Surgical Periodontal Therapy of stage II periodontitis patients and compare it to healthy individuals</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To evaluate Plaque index before &amp; after Non-Surgical Periodontal Therapy of stage II periodontitis patients</measure>
      <time_frame>3 months</time_frame>
      <description>To evaluate Plaque index (0-3 score) before &amp; after Non-Surgical Periodontal Therapy of stage II periodontitis patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate Gingival index before &amp; after Non-Surgical Periodontal Therapy of stage II periodontitis patients</measure>
      <time_frame>3 months</time_frame>
      <description>To evaluate Gingival index (0-3 score) before &amp; after Non-Surgical Periodontal Therapy of stage II periodontitis patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate Probing depth before &amp; after Non-Surgical Periodontal Therapy of stage II periodontitis patients</measure>
      <time_frame>3 months</time_frame>
      <description>To evaluate Probing depth in mm before &amp; after Non-Surgical Periodontal Therapy of stage II periodontitis patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate Clinical attachment level before &amp; after Non-Surgical Periodontal Therapy of stage II periodontitis patients</measure>
      <time_frame>3 months</time_frame>
      <description>To evaluate Clinical attachment level in mm before &amp; after Non-Surgical Periodontal Therapy of stage II periodontitis patients</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Periodontal Disease Stage 2</condition>
    <arm_group>
      <arm_group_label>Healthy individuals</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Stage II periodontitis patients</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Non-surgical periodontal therapy by ultrasonic and universal curettes</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Non surgical periodontal therapy</intervention_name>
      <description>scaling and subgingival debridement</description>
      <arm_group_label>Stage II periodontitis patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with stage II Periodontitis.&#xD;
  &#xD;
            -  Both genders aged from 20-50 years&#xD;
  &#xD;
            -  Minimum 20 natural teeth excluding third molars&#xD;
  &#xD;
            -  Good compliance with the plaque control instructions following initial therapy.&#xD;
  &#xD;
            -  Availability for follow-up and maintenance program.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          .•Smokers&#xD;
  &#xD;
            -  Pregnant and lactating females.&#xD;
  &#xD;
            -  Systemic diseases that could affect the outcome of the therapy (According to Cornell&#xD;
               Medical Index-Health Questionnaire).&#xD;
  &#xD;
            -  Patients taking antibiotics, anti-inflammatory, and immunosuppressive therapy during&#xD;
               the preceding 3 months before the start of the trial and during the study.&#xD;
  &#xD;
            -  Patients who have undergone any periodontal therapy in the last 6 months&#xD;
  &#xD;
            -  Vulnerable groups of patients e.g. (handicapped patients).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hala A. Abuel Ela, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Professor at Faculty of Dentistry, Ain Shams University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nada S. Ahmed</last_name>
      <phone>00201060041571</phone>
      <email>nadazidan1271994@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yasmine A. Fouad, lecturer</last_name>
      <phone>00201005793929</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Faculty of Dentistry-Ain Shams University</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <link>
      <url>http://www.ijdr.in/article.asp?issn=0970-9290;year=2018;volume=29;issue=3;spage=280;epage=285;aulast=Guruprasad;type=0</url>
      <description>Effect of nonsurgical periodontal therapy on interleukin-34 levels in periodontal health and disease</description>
    </link>
    <results_reference>
      <citation>Dikilitas A, Karaaslan F, Evirgen S, Ertugrul AS. Gingival crevicular fluid CSF-1 and IL-34 levels in patients with stage III grade C periodontitis and uncontrolled type 2 diabetes mellitus. J Periodontal Implant Sci. 2022 Dec;52(6):455-465. doi: 10.5051/jpis.2106260313. Epub 2022 Apr 12.</citation>
      <PMID>36468466</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Nada Zidan</investigator_full_name>
      <investigator_title>MSc student</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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/NCT05962567
  org study id: FDASU-Rec IM112108
  nct id: NCT05962567
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Aim of the study:
  
          1. To investigate changes in the levels of Interleukin 34 (IL-34) in the Gingival
             crevicular fluid(GCF) of patients with stage II periodontitis patients before and after
             nonsurgical periodontal therapy and compare it with healthy individuals
  
          2. To correlate changes in Gingival crevicular fluid level of Interleukin 34 with changes
             in periodontal parameters after nonsurgical periodontal therapy
  Periodontal disease is a chronic disease of various inflammatory diseases where the early
        symptoms are gingival redness, swelling, and bleeding. As the disease progresses, periodontal
        pockets, clinical attachment loss (CAL) as well as alveolar bone resorption may occur. If
        left untreated, periodontal disease can lead to loss of teeth which directly affects
        patient's mastication.
  
        A new system of periodontal classification has been adopted, in which the types of disease
        that were previously identified as "chronic" or "aggressive" Armitage, 1999 are now
        classified under one category ("periodontitis") and re-diagnosed on the basis of many
        variants (staging and grading system).
  
        The stage is based on the severity of the disease and the complexity of the disease
        management (in terms of loss of clinical attachment between teeth (CAL), radiographic bone
        loss, and tooth loss), complexity, and size and distribution. Grading provides additional
        information about the biological features of the disease, including history-based analysis of
        the progression rate of periodontitis; progression risk assessment; analysis of possible
        adverse effects of treatment; and risk assessment that the disease or its treatment may
        adversely affect the patient's normal life.
  
        Periodontitis is described in four stages ranging from Stage I: Initial periodontitis (CAL
        1-2mm), Stage II: Moderate periodontitis (CAL 3-4 mm), Stage III: Severe periodontitis with
        potential for additional tooth loss (<4), and(CAL≥5mm) Stage IV: Severe periodontitis with
        potential for loss of dentition (≥5) and (CAL≥5mm). Grading focuses on assessing risk factors
        like smoking, diabetes, and outcomes of scaling and root debridement. Grade A: Slow rate of
        progression (no CAL loss over 5 years), Grade B: Moderate rate of progression (CAL loss<2mm
        over 5years), and Grade C: Rapid rate of progression (CAL loss ≥2 mm over 5 years).
  
        Periodontitis occurs due to a complex of genetic, environmental, and bacterial interaction in
        which bacterial and host factors play an important role. The imbalance between the previous
        two factors results in a completely different change from health state to inflammatory
        disease and once inflammation has begun, activation of many cytokines and molecular
        mechanisms occur.
  
        Cytokines are defined as soluble small proteins (~5-20 kDa) which bind to specific receptors
        on certain cells, stimulate some internal cellular changes, and cause multiple genetic and
        chemical regulations. While molecular mechanisms activate the host-derived proteinase that
        allow the loss of the marginal periodontal ligament fibers, the migration of the junctional
        epithelium apically, and the proliferation of bacterial biofilm on the root surface.
  
        There are two different types of inflammatory cytokines: proinflammatory cytokines that is
        involved in inflammatory reactions including IL-1β, IL-6, IL-12, TNF-α, and anti-inflammatory
        cytokines that regulate or control the pro-inflammatory cytokine response including IL-4,
        Interleukin-1 receptor antagonist (IL-1RA) and IL-10
  
        Scaling and root debridement (NSPT) aimed at mechanical removal of bacterial plaque from the
        tooth surface is considered the "gold standard." This procedure decreases the number of
        Gram-negative bacteria in favor of Gram-positive bacteria as well as reduces the overall
        number of microorganisms in periodontal pockets and decrease amount of proinflammatory
        cytokines.
  
        Traditional clinical periodontal diagnostic parameters used include probing depths, bleeding
        on probing, clinical attachment levels, plaque index, and radiographs assessing alveolar bone
        level. They are limited, in that only disease history, not current disease status, can be
        assessed.
  
        Recent methods in oral and periodontal disease diagnostic research are identifying
        periodontal risk which is quantified by objective measures like biomarkers which are
        diagnostic tools to measure periodontal disease at the molecular, cellular, tissue, and
        clinical levels.
  
        There are many bone resorption biomarkers such as receptor activator nuclear factor kappa B
        (RANKL), a tumor necrosis factor (TNF) family cytokine, as well as on macrophage
        colony-stimulating factor (M-CSF) . M-CSF is required for osteoclastogenesis, stimulating
        both adhesion and proliferation of osteoclast precursors. The novel cytokine interleukin 34
        (IL-34) is the second active component of colony-stimulating factor receptor (CSF-1R). IL-34
        was shown to stimulate monocyte activation and colonization of macrophages from bone marrow
        cells.
  
        IL-34 messenger RNA (mRNA) is expressed in a number of tissues, including the heart, brain,
        lungs, liver, kidneys, spleen, thymus, testes, ovary, small intestine, prostate, and colon,
        as well as -spleen.
  
        IL-34 plays an important role in RANKL-induced osteoclastogenesis. Inhibition of the CSF-1
        receptor by IL-34 has been shown to reduce alveolar bone loss in a periodontal rat model,
        highlighting their role in periodontal pathology.
  
        The diagnostic potential of gingival crevicular fluid (GCF) has been evaluated from
        confirming health and disease status to recent predictive tool. It distinguishes between
        healthy sites of diseased individuals and healthy sites of periodontally healthy people in
        the microbial profile and the concentration and formation of molecular biomarkers and
        therefore predicts patient-or-site-based disease Study in 2018, reported that estimation of
        IL-34 level detects high-risk individuals with periodontitis and systemic diseases, such as
        diabetes as high levels of IL-34 in gingival crevicular fluid (GCF) and plasma of patients
        with chronic periodontitis, further increased when accompanied with type 2 diabetes mellitus
        (T2DM) IL-34 can be considered a potential inflammatory biomarker of periodontal disease as
        GCF IL-34 levels was high in patients with periodontitis and decreased after NSPT.
  
        On the other hand, salivary levels of IL-34 were significantly lower in the periodontitis
        group compared to both healthy groups and gingivitis. After receiving non-surgical
        periodontal treatment at 3 and 6 months post-treatment, IL-34 significantly increased 3
        months after treatment compared with baseline.
  
        Therefore, Further studies must be carried out to confirm these findings and to better
        understand the possible role of IL-34 in the pathogenesis of periodontal diseases and to
        evaluate its levels in GCF in patients with periodontal disease after non-surgical
        periodontal treatment (NSPT)
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Supra and subgingival scaling will be performed on all patients. Oral Hygiene measures will be instructed following treatment and follow up after 3 months
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 1- To measure the IL - 34 levels in ng/L in GCF before &after Non-Surgical Periodontal Therapy of stage II periodontitis patients and compare it to healthy individuals
  time frame: 3 months
  description: 1- To measure the IL - 34 levels in ng/L in GCF before &after Non-Surgical Periodontal Therapy of stage II periodontitis patients and compare it to healthy individuals
  measure: To evaluate Plaque index before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients
  time frame: 3 months
  description: To evaluate Plaque index (0-3 score) before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients
  measure: To evaluate Gingival index before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients
  time frame: 3 months
  description: To evaluate Gingival index (0-3 score) before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients
  measure: To evaluate Probing depth before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients
  time frame: 3 months
  description: To evaluate Probing depth in mm before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients
  measure: To evaluate Clinical attachment level before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients
  time frame: 3 months
  description: To evaluate Clinical attachment level in mm before & after Non-Surgical Periodontal Therapy of stage II periodontitis patients
  arm group label: Healthy individuals
  arm group type: No Intervention
  description: No intervention
  arm group label: Stage II periodontitis patients
  arm group type: Active Comparator
  description: Non-surgical periodontal therapy by ultrasonic and universal curettes
  intervention type: Other
  intervention name: Non surgical periodontal therapy
  description: scaling and subgingival debridement
  arm group label: Stage II periodontitis patients
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hala A. Abuel Ela, Professor
  role: Study Director
  affiliation: Professor at Faculty of Dentistry, Ain Shams University
  last name: Nada S. Ahmed
  phone: 00201060041571
  email: nadazidan1271994@gmail.com
  last name: Yasmine A. Fouad, lecturer
  phone: 00201005793929
  facility: 
  status: Recruiting
  country: Egypt
  url: http://www.ijdr.in/article.asp?issn=0970-9290;year=2018;volume=29;issue=3;spage=280;epage=285;aulast=Guruprasad;type=0
  description: Effect of nonsurgical periodontal therapy on interleukin-34 levels in periodontal health and disease
  citation: Dikilitas A, Karaaslan F, Evirgen S, Ertugrul AS. Gingival crevicular fluid CSF-1 and IL-34 levels in patients with stage III grade C periodontitis and uncontrolled type 2 diabetes mellitus. J Periodontal Implant Sci. 2022 Dec;52(6):455-465. doi: 10.5051/jpis.2106260313. Epub 2022 Apr 12.
  PMID: 36468466
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Nada Zidan
  investigator title: MSc student
  mesh term: Periodontal Diseases