<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/NCT03227367</url>
  </required_header>
  <id_info>
    <org_study_id>MU-107-IEC/2014</org_study_id>
    <nct_id>NCT03227367</nct_id>
  </id_info>
  <brief_title>Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.</brief_title>
  <official_title>Platelet Rich Fibrin/Biphasic Calcium Phosphate Impairs Osteoclasts Differentiation and Promotes Apoptosis by the Intrinsic Mitochondrial Pathway in Chronic Periodontitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meenakshi Ammal Dental College and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meenakshi Ammal Dental College and Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study is an effort to investigate the hypothesis that Platelet Rich&#xD;
      Fibrin/Biphasic Calcium Phosphate may play a role in inhibiting osteoclasts differentiation&#xD;
      and in bone loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design&#xD;
&#xD;
      Fifty-five individuals from a suburban population were recruited. Out of them, 5 individuals&#xD;
      refused to participate in the study. Finally, 50 participants were selected and divided into&#xD;
      two groups, control group [Healthy individuals]: 25 Males/Females, aged 25 to 35 years and&#xD;
      test group [Chronic periodontitis patients]: 25 Males/Females aged 30 to 45 years.&#xD;
&#xD;
      Demographic variables and periodontal parameters were measured in both the groups.The&#xD;
      investigators explored the effect of Platelet rich fibrin (PRF)/Biphasic calcium phosphate&#xD;
      (BCP) on differentiation and survival of osteoclasts obtained from peripheral blood of&#xD;
      Chronic Periodontitis patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 17, 2014</start_date>
  <completion_date type="Actual">March 18, 2017</completion_date>
  <primary_completion_date type="Actual">April 13, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Control group: (Healthy individuals) comprised of 25 participants with clinically healthy periodontium.&#xD;
Test group: (Chronic periodontitis patients) comprised of 25 participants with signs of clinical inflammation and bone loss.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>probing pocket depth</measure>
    <time_frame>base line</time_frame>
    <description>probing pocket dept was measured using Williams periodontal probe at base line</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Protein expression on osteoclast cells was estimated with BCP, PRF alone and BCP/PRF combination.</measure>
    <time_frame>24 hours from baseline</time_frame>
    <description>Protein expression on cells was analyzed using Western blot in all the groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The activity of caspase-3 in OCs.</measure>
    <time_frame>24 hours from base line</time_frame>
    <description>The activity of caspase-3 was seen in OCs in all the groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Periodontal Disease</condition>
  <condition>Periodontal Bone Loss</condition>
  <condition>Osteoclastic Bone Loss</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mononuclear cells isolated from the peripheral blood of 25 chronic periodontitis patients were interveened with 1ml/well preparation of Platelet rich fibrin(PRF), Biphasic calcium phosphate (BCP) and PRF and BCP combination in-vitro.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Mononuclear cells isolated from the peripheral blood of healthy individuals in-vitro.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>other : PRF</intervention_name>
    <description>mononuclear cells from the peripheral blood of chronic periodontitis patients were intervened with PRF, BCP and PRF/BCP combination</description>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <other_name>others : BCP</other_name>
    <other_name>others : PRF/BCP combination</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria: (Control group)&#xD;
&#xD;
          -  Subjects with age group between 30 to 45 years.&#xD;
&#xD;
          -  Non-smokers.&#xD;
&#xD;
          -  No previous history of periodontal treatment.&#xD;
&#xD;
        Inclusion Criteria: (Test group)&#xD;
&#xD;
          -  Subjects with age group between 30 to 45 years.&#xD;
&#xD;
          -  Presence of atleast 20 teeth&#xD;
&#xD;
          -  More than 30% of the sites with clinical attachment loss.&#xD;
&#xD;
          -  Non-smokers.&#xD;
&#xD;
          -  No previous history of periodontal treatment.&#xD;
&#xD;
        Exclusion Criteria: ( both the groups)&#xD;
&#xD;
          -  Individuals with systemic disease&#xD;
&#xD;
          -  Subjects under antibiotics or anti-inflammatory drugs within the previous 3 months.&#xD;
&#xD;
          -  Pregnant and lactating women.&#xD;
&#xD;
          -  Allergic to antibiotics.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>shila samuel, MS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VRR diagnostic institute chennai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>jaideep mahendra, MDS,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>meenakshi ammal dental college chennai</affiliation>
  </overall_official>
  <results_reference>
    <citation>Wu CL, Lee SS, Tsai CH, Lu KH, Zhao JH, Chang YC. Platelet-rich fibrin increases cell attachment, proliferation and collagen-related protein expression of human osteoblasts. Aust Dent J. 2012 Jun;57(2):207-12. doi: 10.1111/j.1834-7819.2012.01686.x.</citation>
    <PMID>22624763</PMID>
  </results_reference>
  <results_reference>
    <citation>Colucci S, Mori G, Brunetti G, Coricciati M, Pignataro P, Oranger A, Cirulli N, Mastrangelo F, Grassi FR, Grano M. Interleukin-7 production by B lymphocytes affects the T cell-dependent osteoclast formation in an in vitro model derived from human periodontitis patients. Int J Immunopathol Pharmacol. 2005 Jul-Sep;18(3 Suppl):13-9.</citation>
    <PMID>16848983</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>June 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meenakshi Ammal Dental College and Hospital</investigator_affiliation>
    <investigator_full_name>Dr.Jaideep Mahendra</investigator_full_name>
    <investigator_title>Professor, Director post graduate studies</investigator_title>
  </responsible_party>
  <keyword>biomaterials</keyword>
  <keyword>apoptosis</keyword>
  <keyword>bone regeneration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alveolar Bone Loss</mesh_term>
    <mesh_term>Bone Resorption</mesh_term>
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Periodontal Diseases</mesh_term>
    <mesh_term>Chronic Periodontitis</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/NCT03227367
org study id: MU-107-IEC/2014
nct id: NCT03227367
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The present study is an effort to investigate the hypothesis that Platelet Rich
      Fibrin/Biphasic Calcium Phosphate may play a role in inhibiting osteoclasts differentiation
      and in bone loss.
Study design

      Fifty-five individuals from a suburban population were recruited. Out of them, 5 individuals
      refused to participate in the study. Finally, 50 participants were selected and divided into
      two groups, control group [Healthy individuals]: 25 Males/Females, aged 25 to 35 years and
      test group [Chronic periodontitis patients]: 25 Males/Females aged 30 to 45 years.

      Demographic variables and periodontal parameters were measured in both the groups.The
      investigators explored the effect of Platelet rich fibrin (PRF)/Biphasic calcium phosphate
      (BCP) on differentiation and survival of osteoclasts obtained from peripheral blood of
      Chronic Periodontitis patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Control group: (Healthy individuals) comprised of 25 participants with clinically healthy periodontium.
Test group: (Chronic periodontitis patients) comprised of 25 participants with signs of clinical inflammation and bone loss.
primary purpose: Other
masking: None (Open Label)
measure: probing pocket depth
time frame: base line
description: probing pocket dept was measured using Williams periodontal probe at base line
measure: Protein expression on osteoclast cells was estimated with BCP, PRF alone and BCP/PRF combination.
time frame: 24 hours from baseline
description: Protein expression on cells was analyzed using Western blot in all the groups
measure: The activity of caspase-3 in OCs.
time frame: 24 hours from base line
description: The activity of caspase-3 was seen in OCs in all the groups
arm group label: Test group
arm group type: Experimental
description: Mononuclear cells isolated from the peripheral blood of 25 chronic periodontitis patients were interveened with 1ml/well preparation of Platelet rich fibrin(PRF), Biphasic calcium phosphate (BCP) and PRF and BCP combination in-vitro.
arm group label: control group
arm group type: Other
description: Mononuclear cells isolated from the peripheral blood of healthy individuals in-vitro.
intervention type: Other
intervention name: other : PRF
description: mononuclear cells from the peripheral blood of chronic periodontitis patients were intervened with PRF, BCP and PRF/BCP combination
arm group label: Test group
arm group label: control group
other name: others : BCP
other name: others : PRF/BCP combination
criteria: 
gender: All
minimum age: 25 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: shila samuel, MS, PhD
role: Principal Investigator
affiliation: VRR diagnostic institute chennai
last name: jaideep mahendra, MDS,PhD
role: Principal Investigator
affiliation: meenakshi ammal dental college chennai
citation: Wu CL, Lee SS, Tsai CH, Lu KH, Zhao JH, Chang YC. Platelet-rich fibrin increases cell attachment, proliferation and collagen-related protein expression of human osteoblasts. Aust Dent J. 2012 Jun;57(2):207-12. doi: 10.1111/j.1834-7819.2012.01686.x.
PMID: 22624763
citation: Colucci S, Mori G, Brunetti G, Coricciati M, Pignataro P, Oranger A, Cirulli N, Mastrangelo F, Grassi FR, Grano M. Interleukin-7 production by B lymphocytes affects the T cell-dependent osteoclast formation in an in vitro model derived from human periodontitis patients. Int J Immunopathol Pharmacol. 2005 Jul-Sep;18(3 Suppl):13-9.
PMID: 16848983
responsible party type: Principal Investigator
investigator affiliation: Meenakshi Ammal Dental College and Hospital
investigator full name: Dr.Jaideep Mahendra
investigator title: Professor, Director post graduate studies
mesh term: Alveolar Bone Loss
mesh term: Bone Resorption
mesh term: Periodontitis
mesh term: Periodontal Diseases
mesh term: Chronic Periodontitis
sharing ipd: No