<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/NCT03011086</url>
  </required_header>
  <id_info>
    <org_study_id>PMVIDS/OMR/0016/2014</org_study_id>
    <nct_id>NCT03011086</nct_id>
  </id_info>
  <brief_title>Evaluation of Auto Antibodies in Oral Sub Mucous Fibrosis</brief_title>
  <official_title>Evaluation of Auto Antibodies in Oral Sub Mucous Fibrosis - a Clinico-pathological Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Panineeya Mahavidyalaya Institute of Dental Sciences &amp; Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Panineeya Mahavidyalaya Institute of Dental Sciences &amp; Research Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The etiology of OSMF is considered to be multifactorial. However, Role of autoimmunity had&#xD;
      been suggested as one of the factors but remains unproven.&#xD;
&#xD;
      The present study is undertaken to evaluate the presence of auto antibodies in OSMF patients&#xD;
      to pave a way for new arena of treatment with the etiology of this persistent condition&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oral submucous fibrosis (OSMF) is a potentially malignant disorder affecting any part of the&#xD;
      oral cavity, sometimes pharynx associated with juxta epithelial fibrosis causing progressive&#xD;
      trismus leading to dysphagia. It is mainly seen in the Asian countries with more prevalence&#xD;
      in India.&#xD;
&#xD;
      Etiology of OSMF is considered to be multifactorial. However, it is strongly associated with&#xD;
      the use of arecanut in various forms and also in combination with other compounding factors.&#xD;
      Autoimmunity had been suggested as one of the factors yet unproven.&#xD;
&#xD;
      Few studies reveal that there is high incidence of Autoantibodies including antinuclear&#xD;
      (ANA), Anti smooth muscle (SMA), Anti thyroid microsomal (TMA), and anti reticulin antibodies&#xD;
      in OSMF patients. These findings have not been consistent in further studies which needs&#xD;
      further more research in this.&#xD;
&#xD;
      A study concentrated on quantitation of circulating immune complexes (CIC) levels which was&#xD;
      established in patients with oral cancer and oral precancerous lesions. The levels were&#xD;
      compared with that in normal controls and chronic chewers of betel quid with no signs of any&#xD;
      disease. Both patients with oral cancer and oral precancerous lesions had elevated CIC when&#xD;
      compared to both the control groups. The most interesting observations were (a) the CIC&#xD;
      levels in the chewing controls were significantly raised when compared to normal controls;&#xD;
      and (b) the CIC levels in the patients with premalignant lesions were elevated almost to the&#xD;
      same levels as in the oral cancer patients.&#xD;
&#xD;
      HLA-typing was carried on areca nut chewers. however, it was unable to demonstrate a specific&#xD;
      pattern of HLA-antigen frequencies in chewers with or without the disease. It is not&#xD;
      necessarily a HLA-associated susceptibility in Oral Submucous Fibrosis.&#xD;
&#xD;
      Due to less number of articles published on autoantibodies, this study is done to evaluate&#xD;
      the presence of such auto antibodies in OSMF patients thereby paving way for new arena of&#xD;
      treatment on par with the etiology of this persistent condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</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>Evaluation of auto antibodies in oral sub mucous fibrosis</measure>
    <time_frame>one and half year</time_frame>
    <description>The subjects in the study suffering from oral submucous fibrosis will be clinically evaluated and graded based on criteria given by Khanna et al classification. All the subjects included in the study will also be subjected to serum analysis for presence of auto antibodies in their serum by Titerplane technique.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Oral Submucous Fibrosis</condition>
  <arm_group>
    <arm_group_label>oral sub mucous fibrosis</arm_group_label>
    <description>patients suffering with oral sub mucous fibrosis due to gutka/pan chewing confirmed by clinical examination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>patients having gutka/ pan chewing habit without oral sub mucous fibrosis in oral cavity</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A total number of patients were 70 patients (Group A- 35 OSMF patients, Group B- 35&#xD;
        controls) of both the genders&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are willing for the study.&#xD;
&#xD;
          -  A positive history of chewing arecanut, and/or smoking tobacco and alcohol.&#xD;
&#xD;
          -  Patients with clinical and histopathological features of oral submucous fibrosis.&#xD;
&#xD;
          -  Patients with OSMF not under any treatment for the same&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling patients who do not want to be part of the study.&#xD;
&#xD;
          -  Patients with known autoimmune disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>NALLAN CHAITANYA, MDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>ASSOCIATE PROFESSOR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Panineeya Institute of Dental Sciences</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>December 18, 2017</last_update_submitted>
  <last_update_submitted_qc>December 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Panineeya Mahavidyalaya Institute of Dental Sciences &amp; Research Centre</investigator_affiliation>
    <investigator_full_name>NALLAN CHAITANYA</investigator_full_name>
    <investigator_title>ASSOCIATE PROFESSOR, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY</investigator_title>
  </responsible_party>
  <keyword>Autoantibodies, Oral Submucous Fibrosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oral Submucous Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03011086
org study id: PMVIDS/OMR/0016/2014
nct id: NCT03011086
lead sponsor: 
has dmc: No
The etiology of OSMF is considered to be multifactorial. However, Role of autoimmunity had
      been suggested as one of the factors but remains unproven.

      The present study is undertaken to evaluate the presence of auto antibodies in OSMF patients
      to pave a way for new arena of treatment with the etiology of this persistent condition
Oral submucous fibrosis (OSMF) is a potentially malignant disorder affecting any part of the
      oral cavity, sometimes pharynx associated with juxta epithelial fibrosis causing progressive
      trismus leading to dysphagia. It is mainly seen in the Asian countries with more prevalence
      in India.

      Etiology of OSMF is considered to be multifactorial. However, it is strongly associated with
      the use of arecanut in various forms and also in combination with other compounding factors.
      Autoimmunity had been suggested as one of the factors yet unproven.

      Few studies reveal that there is high incidence of Autoantibodies including antinuclear
      (ANA), Anti smooth muscle (SMA), Anti thyroid microsomal (TMA), and anti reticulin antibodies
      in OSMF patients. These findings have not been consistent in further studies which needs
      further more research in this.

      A study concentrated on quantitation of circulating immune complexes (CIC) levels which was
      established in patients with oral cancer and oral precancerous lesions. The levels were
      compared with that in normal controls and chronic chewers of betel quid with no signs of any
      disease. Both patients with oral cancer and oral precancerous lesions had elevated CIC when
      compared to both the control groups. The most interesting observations were (a) the CIC
      levels in the chewing controls were significantly raised when compared to normal controls;
      and (b) the CIC levels in the patients with premalignant lesions were elevated almost to the
      same levels as in the oral cancer patients.

      HLA-typing was carried on areca nut chewers. however, it was unable to demonstrate a specific
      pattern of HLA-antigen frequencies in chewers with or without the disease. It is not
      necessarily a HLA-associated susceptibility in Oral Submucous Fibrosis.

      Due to less number of articles published on autoantibodies, this study is done to evaluate
      the presence of such auto antibodies in OSMF patients thereby paving way for new arena of
      treatment on par with the etiology of this persistent condition.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of auto antibodies in oral sub mucous fibrosis
time frame: one and half year
description: The subjects in the study suffering from oral submucous fibrosis will be clinically evaluated and graded based on criteria given by Khanna et al classification. All the subjects included in the study will also be subjected to serum analysis for presence of auto antibodies in their serum by Titerplane technique.
arm group label: oral sub mucous fibrosis
description: patients suffering with oral sub mucous fibrosis due to gutka/pan chewing confirmed by clinical examination
arm group label: control group
description: patients having gutka/ pan chewing habit without oral sub mucous fibrosis in oral cavity
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: NALLAN CHAITANYA, MDS
role: Principal Investigator
affiliation: ASSOCIATE PROFESSOR
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
investigator full name: NALLAN CHAITANYA
investigator title: ASSOCIATE PROFESSOR, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY
mesh term: Oral Submucous Fibrosis
mesh term: Fibrosis
sharing ipd: No