<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/NCT03775967</url>
  </required_header>
  <id_info>
    <org_study_id>UGD-H-18-10-31-10</org_study_id>
    <nct_id>NCT03775967</nct_id>
  </id_info>
  <brief_title>Estimation of Sialic Acid and IL10 Levels in Stage 1 and 2 Periodontitis Patients</brief_title>
  <official_title>Estimation of Sialic Acid and IL10 Levels in Stage 1 and 2 Periodontitis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajman University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajman University</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>
      Sialic acid (SA) is the generic term given to a family of acetylated derivatives of&#xD;
      neuraminic acid. SA is a 9 carbon monosaccharide. An important function of host SA is to&#xD;
      regulate innate immunity. SA is present in several acute phase proteins which are known to be&#xD;
      associated with periodontitis. There exists a need for a biomarker, for early detection of&#xD;
      disease evolution and more robust therapy efficacy measurements. Till date, there is very&#xD;
      little data regarding simultaneous estimation and comparison of total SA content in saliva.&#xD;
      IL-10, an anti-inflammatory cytokine, regulates the synthesis of pro-inflammatory cytokines&#xD;
      such as IL-1, -2, -6 and stimulates protective antibody production. IL-10 is expressed in&#xD;
      both healthy and diseased human periodontal tissues and is reported to be reduced in patients&#xD;
      infected with Aggregatibacter actinomycetemcomitans.&#xD;
&#xD;
      The present study was therefore undertaken with an aim, to not only assess the levels of&#xD;
      TSA(Total sialic acid levels),but also of IL 10 levels in saliva from stage 1(mild) to stage&#xD;
      2(moderate) periodontitis patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Selection of patients by grading the patients according to criteria stage 1 and 2&#xD;
      Periodontitis&#xD;
&#xD;
      Obtaining consent from patients participating in the study&#xD;
&#xD;
      Collection of saliva-unstimulated whole saliva, the samples will be stored at -20 degree&#xD;
      Centigrade and later placed in a 1.5ml centrifuge tubes which will be placed in a vacuum cool&#xD;
      box indicated for laboratory samples and transported to the lab for investigations. It will&#xD;
      be centrifuged at 2500 rpm for 10 mins,stored at -80 deg C. SA(sialic acid) levels will be&#xD;
      determined by thiobarbutic acid method of aminoff and ELISA methods. SA levels will be&#xD;
      measured in mg/dl,IL10 as in direct measurement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2018</start_date>
  <completion_date type="Actual">February 10, 2019</completion_date>
  <primary_completion_date type="Actual">January 10, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sialic acid levels in stage 1 periodontitis</measure>
    <time_frame>From baseline to 3 months</time_frame>
    <description>Sialic acid is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sialic acid levels in stage 2 periodontitis</measure>
    <time_frame>From baseline to 3 months</time_frame>
    <description>Sialic acid is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IL10 levels in stage 1 periodontitis</measure>
    <time_frame>From baseline to 3 months</time_frame>
    <description>IL10 is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IL10 levels in stage 2 periodontitis</measure>
    <time_frame>From baseline to 3 months</time_frame>
    <description>IL10 is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients</description>
  </primary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Periodontal Disease</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>sialic acid</intervention_name>
    <description>sialic acid level estimation in salivary samples</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>IL10</intervention_name>
    <description>IL10 estimation in salivary samples</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Sialic acid and IL10 are assessed by taking salivary samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients attending the dental clinics in AB Shetty Institute of Dental sciences,Mangalore&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All the subjects should be within the age group of 18 to 55 years&#xD;
&#xD;
          -  subject should have atleast 18 natural teeth excluding third molars.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of periodontal debridement or periodontal surgery in preceding six months or&#xD;
             any antimicrobial therapy, anti-inflammatory drugs.&#xD;
&#xD;
          -  corticosteroids, in previous three months&#xD;
&#xD;
          -  systemically compromised individuals&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  pregnant and lactating women&#xD;
&#xD;
          -  Medical history for absence of systemic disorders such as diabetes mellitus&#xD;
&#xD;
          -  cardiovascular diseases&#xD;
&#xD;
          -  pneumonia&#xD;
&#xD;
          -  tuberculosis&#xD;
&#xD;
          -  rheumatoid arthritis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AB shetty institute of dental sciences</name>
      <address>
        <city>Mangalore</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>November 23, 2019</last_update_submitted>
  <last_update_submitted_qc>November 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajman University</investigator_affiliation>
    <investigator_full_name>sudhir rama varma</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>sialic acid</keyword>
  <keyword>IL10</keyword>
  <keyword>stage 1 periodontal disease</keyword>
  <keyword>stage 2 periodontal disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03775967
org study id: UGD-H-18-10-31-10
nct id: NCT03775967
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Sialic acid (SA) is the generic term given to a family of acetylated derivatives of
      neuraminic acid. SA is a 9 carbon monosaccharide. An important function of host SA is to
      regulate innate immunity. SA is present in several acute phase proteins which are known to be
      associated with periodontitis. There exists a need for a biomarker, for early detection of
      disease evolution and more robust therapy efficacy measurements. Till date, there is very
      little data regarding simultaneous estimation and comparison of total SA content in saliva.
      IL-10, an anti-inflammatory cytokine, regulates the synthesis of pro-inflammatory cytokines
      such as IL-1, -2, -6 and stimulates protective antibody production. IL-10 is expressed in
      both healthy and diseased human periodontal tissues and is reported to be reduced in patients
      infected with Aggregatibacter actinomycetemcomitans.

      The present study was therefore undertaken with an aim, to not only assess the levels of
      TSA(Total sialic acid levels),but also of IL 10 levels in saliva from stage 1(mild) to stage
      2(moderate) periodontitis patients
Selection of patients by grading the patients according to criteria stage 1 and 2
      Periodontitis

      Obtaining consent from patients participating in the study

      Collection of saliva-unstimulated whole saliva, the samples will be stored at -20 degree
      Centigrade and later placed in a 1.5ml centrifuge tubes which will be placed in a vacuum cool
      box indicated for laboratory samples and transported to the lab for investigations. It will
      be centrifuged at 2500 rpm for 10 mins,stored at -80 deg C. SA(sialic acid) levels will be
      determined by thiobarbutic acid method of aminoff and ELISA methods. SA levels will be
      measured in mg/dl,IL10 as in direct measurement.
observational model: Cohort
time perspective: Prospective
measure: Sialic acid levels in stage 1 periodontitis
time frame: From baseline to 3 months
description: Sialic acid is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients
measure: Sialic acid levels in stage 2 periodontitis
time frame: From baseline to 3 months
description: Sialic acid is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients
measure: IL10 levels in stage 1 periodontitis
time frame: From baseline to 3 months
description: IL10 is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients
measure: IL10 levels in stage 2 periodontitis
time frame: From baseline to 3 months
description: IL10 is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients
intervention type: Diagnostic Test
intervention name: sialic acid
description: sialic acid level estimation in salivary samples
intervention type: Diagnostic Test
intervention name: IL10
description: IL10 estimation in salivary samples
Sialic acid and IL10 are assessed by taking salivary samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Ajman University
investigator full name: sudhir rama varma
investigator title: Assistant Professor
mesh term: Periodontitis
mesh term: Periodontal Diseases
sharing ipd: Undecided