<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/NCT03043066</url>
  </required_header>
  <id_info>
    <org_study_id>MADC/IRB-IX/2016/193</org_study_id>
    <nct_id>NCT03043066</nct_id>
  </id_info>
  <brief_title>Serum TRAP-5b Levels in Patients With Generalized Chronic Periodontitis</brief_title>
  <official_title>The Effect of Non-surgical Periodontal Therapy With or Without Systemic Administration of Amoxicillin and Metronidazole on Serum Levels of TRAP-5b in Patients With Generalized Chronic Periodontitis - A Comparative Clinical Study</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>
      To compare the effect of non-surgical periodontal therapy with or without systemic&#xD;
      administration of amoxicillin and metronidazole on the concentration of serum levels of&#xD;
      TRAP-5b in patients with generalized chronic periodontitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      30 Chronic periodontitis subjects were divided into two groups- group A underwent scaling and&#xD;
      root planing and group B underwent scaling and root planing with systemic administration of&#xD;
      amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days.&#xD;
&#xD;
      Periodontal parameters probing pocket depth and clinical attachment level were measured at&#xD;
      baseline and at 3rd month. Serum TRAP-5b levels were also measured at baseline, 1 month and&#xD;
      at 3rd month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Actual">October 1, 2016</completion_date>
  <primary_completion_date type="Actual">July 31, 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>Group A - scaling and root planing Group B - scaling and root planing along with antibiotic intervention of amoxicillin and metronidazole</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum levels of TRAP-5b</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Concentration of serum levels of TRAP-5b was assessed at baseline and at 3rd month using ELISA method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Probing pocket depth</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Probing pocket depth was measured using Williams periodontal probe at baseline and at 3rd month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Clinical attachment level was measured as a distance between base of pocket and a fixed point on the crown, such as cemento-enamel junction at baseline and at 3rd month.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>Group A -control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>15 subjects underwent scaling and root planing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B-Interventional group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 subjects underwent scaling and root planing along with antibiotic intervention of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Scaling and root planing</intervention_name>
    <description>subjects underwent full mouth supragingival and subgingival scaling</description>
    <arm_group_label>Group A -control group</arm_group_label>
    <other_name>Non-surgical periodontal therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>scaling and root planing along with antibiotic intervention</intervention_name>
    <description>subjects underwent full mouth supragingival and subgingival scaling along with antibiotic intervention of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days</description>
    <arm_group_label>Group B-Interventional group</arm_group_label>
    <other_name>Systemic antibiotics</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of atleast 20 teeth&#xD;
&#xD;
          -  more than 30% of sites with clinical attachment loss of ≥ 5 mm&#xD;
&#xD;
          -  non-smokers&#xD;
&#xD;
          -  no previous history of periodontal therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic diseases&#xD;
&#xD;
          -  under antibiotics or anti-inflammatory drugs within previous 3 months&#xD;
&#xD;
          -  pregnant and lactating women&#xD;
&#xD;
          -  allergic to antibiotics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandhya CH, BDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meenakshi Ammal Dental College &amp; Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Cosgarea R, Juncar R, Heumann C, Tristiu R, Lascu L, Arweiler N, Stavropoulos A, Sculean A. Non-surgical periodontal treatment in conjunction with 3 or 7 days systemic administration of amoxicillin and metronidazole in severe chronic periodontitis patients. A placebo-controlled randomized clinical study. J Clin Periodontol. 2016 Sep;43(9):767-77. doi: 10.1111/jcpe.12559. Epub 2016 Jun 23.</citation>
    <PMID>27027501</PMID>
  </reference>
  <reference>
    <citation>Keestra JA, Grosjean I, Coucke W, Quirynen M, Teughels W. Non-surgical periodontal therapy with systemic antibiotics in patients with untreated chronic periodontitis: a systematic review and meta-analysis. J Periodontal Res. 2015 Jun;50(3):294-314. doi: 10.1111/jre.12221. Epub 2014 Aug 21.</citation>
    <PMID>25142259</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 28, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 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</investigator_title>
  </responsible_party>
  <keyword>Chronic Periodontitis</keyword>
  <keyword>TRAP-5b</keyword>
  <keyword>Non-surgical periodontal therapy</keyword>
  <keyword>Systemic antibiotics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Antibiotics, Antitubercular</mesh_term>
  </intervention_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/NCT03043066
org study id: MADC/IRB-IX/2016/193
nct id: NCT03043066
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To compare the effect of non-surgical periodontal therapy with or without systemic
      administration of amoxicillin and metronidazole on the concentration of serum levels of
      TRAP-5b in patients with generalized chronic periodontitis.
30 Chronic periodontitis subjects were divided into two groups- group A underwent scaling and
      root planing and group B underwent scaling and root planing with systemic administration of
      amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days.

      Periodontal parameters probing pocket depth and clinical attachment level were measured at
      baseline and at 3rd month. Serum TRAP-5b levels were also measured at baseline, 1 month and
      at 3rd month.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group A - scaling and root planing Group B - scaling and root planing along with antibiotic intervention of amoxicillin and metronidazole
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Serum levels of TRAP-5b
time frame: Baseline and 3 months
description: Concentration of serum levels of TRAP-5b was assessed at baseline and at 3rd month using ELISA method.
measure: Probing pocket depth
time frame: Baseline and 3 months
description: Probing pocket depth was measured using Williams periodontal probe at baseline and at 3rd month
measure: Clinical attachment level
time frame: Baseline and 3 months
description: Clinical attachment level was measured as a distance between base of pocket and a fixed point on the crown, such as cemento-enamel junction at baseline and at 3rd month.
arm group label: Group A -control group
arm group type: Placebo Comparator
description: 15 subjects underwent scaling and root planing
arm group label: Group B-Interventional group
arm group type: Active Comparator
description: 15 subjects underwent scaling and root planing along with antibiotic intervention of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days
intervention type: Procedure
intervention name: Scaling and root planing
description: subjects underwent full mouth supragingival and subgingival scaling
arm group label: Group A -control group
other name: Non-surgical periodontal therapy
intervention type: Drug
intervention name: scaling and root planing along with antibiotic intervention
description: subjects underwent full mouth supragingival and subgingival scaling along with antibiotic intervention of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days
arm group label: Group B-Interventional group
other name: Systemic antibiotics
criteria: 
gender: All
minimum age: 30 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sandhya CH, BDS
role: Principal Investigator
affiliation: Meenakshi Ammal Dental College & Hospital
citation: Cosgarea R, Juncar R, Heumann C, Tristiu R, Lascu L, Arweiler N, Stavropoulos A, Sculean A. Non-surgical periodontal treatment in conjunction with 3 or 7 days systemic administration of amoxicillin and metronidazole in severe chronic periodontitis patients. A placebo-controlled randomized clinical study. J Clin Periodontol. 2016 Sep;43(9):767-77. doi: 10.1111/jcpe.12559. Epub 2016 Jun 23.
PMID: 27027501
citation: Keestra JA, Grosjean I, Coucke W, Quirynen M, Teughels W. Non-surgical periodontal therapy with systemic antibiotics in patients with untreated chronic periodontitis: a systematic review and meta-analysis. J Periodontal Res. 2015 Jun;50(3):294-314. doi: 10.1111/jre.12221. Epub 2014 Aug 21.
PMID: 25142259
responsible party type: Principal Investigator
investigator affiliation: Meenakshi Ammal Dental College and Hospital
investigator full name: Dr.Jaideep Mahendra
investigator title: Professor
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Anti-Bacterial Agents
mesh term: Antibiotics, Antitubercular
sharing ipd: No