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/NCT06025955</url>
    </required_header>
    <id_info>
      <org_study_id>Nehaperio123</org_study_id>
      <nct_id>NCT06025955</nct_id>
    </id_info>
    <brief_title>Evaluation of Outcomes of Minimally Invasive Non- Surgical Versus Surgical Therapy in Furcation Involvement.</brief_title>
    <official_title>Evaluation of Outcomes of Minimally Invasive Non- Surgical Versus Surgical Therapy in Patients With Furcation Involvement in Mandibular Molars - A Non-inferiority Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Postgraduate Institute of Dental Sciences Rohtak</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Postgraduate Institute of Dental Sciences Rohtak</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>
        The reduced rate of success experienced in the treatment of Furcation involvement (FI) seems&#xD;
        to result from the incomplete removal of subgingival plaque and calculus in the&#xD;
        interradicular area owing to the peculiar anatomy of the furcation space.&#xD;
  &#xD;
        Regarding the therapeutic approach, although FI treated with a conservative approach may not&#xD;
        yield the same satisfactory results as single rooted teeth; it has been shown that teeth with&#xD;
        FI have a remarkable survival rate following conservative treatment in patients demonstrating&#xD;
        a satisfactory plaque control. Minimally invasive techniques aim to retain the preoperative&#xD;
        gingival architecture, create a minimal wound and gently handle soft and hard tissues. It&#xD;
        becomes imperative to see the differences in clinical, and patient centered outcomes of&#xD;
        minimally invasive non- surgical versus surgical technique in the management of furcation&#xD;
        involvement in mandibulae molar.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients will be recruited from outpatient clinic of Department of Periodontics, PGIDS,&#xD;
        Rohtak after screening based on given inclusion and exclusion criteria. after initial session&#xD;
        of scaling and root planing patient will be re -elevated at the and of 6 to 8 weeks those&#xD;
        having grade 2 furcation involvement in any mandibular molar and meeting other eligibility&#xD;
        criteria will be randomly allocated to test group and control group Test group -Experimental&#xD;
        sites designated to receive non-surgical treatment will be submitted to careful subgingival&#xD;
        debridement using curettes and ultrasonic device using 3.5 x magnification.&#xD;
  &#xD;
        control group-Surgical technique will be followed with minimally flap reflection and&#xD;
        incisions will be performed with papilla preservation techniques. vertical- releasing&#xD;
        incisions will not be made, and the full-thickness flap will be minimally elevated. The&#xD;
        granulation soft tissue will be dissected with a blade and carefully removed with curettes.&#xD;
        The visible calculus will be carefully removed with curettes and an ultrasonic device. The&#xD;
        flaps will be re-positioned and sutured and patient follow up 3 to 6 months .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>change in horizontal clinical attachment level (HCAL)</measure>
      <time_frame>3 months</time_frame>
      <description>change in horizontal clinical attachment level (HCAL) of the furcation as assessed</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change in horizontal clinical attachment level (HCAL)</measure>
      <time_frame>6 months</time_frame>
      <description>change in horizontal clinical attachment level (HCAL) of the furcation as assessed</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>changes in vertical probing depth of the furcation</measure>
      <time_frame>3 months</time_frame>
      <description>vertical probing depth will be assessed using UNC 15probe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>changes in vertical probing depth of the furcation</measure>
      <time_frame>6 months</time_frame>
      <description>vertical probing depth will be assessed using UNC 15probe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change in changes vertical clinical attachment level of furcation</measure>
      <time_frame>3 months</time_frame>
      <description>change clinical vertical attachment will be assessed using UNC 15 probe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change in vertical clinical attachment level of furcation</measure>
      <time_frame>6 months</time_frame>
      <description>change in vertical clinical attachment level of furcation will be assessed using UNC 15 probe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>probing pocket depth (PPD)reduction</measure>
      <time_frame>3 months</time_frame>
      <description>probing pocket depth (PPD)reduction will be calculated around the molar at 6 sites</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>probing pocket depth (PPD)reduction</measure>
      <time_frame>6 months</time_frame>
      <description>probing pocket depth (PPD)reduction will be calculated around the molar at 6 sites</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Furcation Defects</condition>
    <condition>Open Flap Debridement</condition>
    <condition>Periodontal Diseases</condition>
    <arm_group>
      <arm_group_label>minimally invasive non surgical therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Experimental sites designated to receive non-surgical treatment will be submitted to careful subgingival debridement using curettes and ultrasonic device using 3.5 x magnification.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>open flap debridement</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Surgical technique will be used and the full-thickness flap will be minimally elevated. The granulation soft tissue will be dissected with a blade and carefully removed with curettes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>minimally invasive non- surgical therapy</intervention_name>
      <description>hand and ultrasonic instrumentation will be done</description>
      <arm_group_label>minimally invasive non surgical therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>open flap debridement</intervention_name>
      <description>flap surgery will be done</description>
      <arm_group_label>open flap debridement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Systemically healthy patients with diagnosis of generalized stage 3 periodontitis&#xD;
               (Grade A or B) with at least one mandibular molar with FI (Degree 1 or 2-according to&#xD;
               Hamp, 1975 and Subclass A or B- according to Tarnow and Fletcher, 1984), interproximal&#xD;
               bone coronal to the furcation fornix and root trunk length ≤ cervical two thirds of&#xD;
               the root length as measured on a periapical radiograph.&#xD;
  &#xD;
            -  Full mouth plaque score &lt; 30% after initial therapy&#xD;
  &#xD;
            -  Full mouth bleeding score &lt; 30% after initial therapy&#xD;
  &#xD;
            -  Having undergone a course of subgingival instrumentation in the past three months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or lactating females&#xD;
  &#xD;
            -  Requiring antibiotic premedication&#xD;
  &#xD;
            -  Received antibiotic treatment in the previous 3 months&#xD;
  &#xD;
            -  Previous periodontal surgery in the last 1 year&#xD;
  &#xD;
            -  Smokers&#xD;
  &#xD;
            -  Pulpal or periapical pathology&#xD;
  &#xD;
            -  Third molar&#xD;
  &#xD;
            -  Non restorable tooth&#xD;
  &#xD;
            -  Trauma from occlusion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Neha AGGARWAL, BDS</last_name>
      <role>Principal Investigator</role>
      <affiliation>PT BD SHARMA UHSR HARAYANA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>DR. RITIKA ARORA, MDS</last_name>
      <phone>9810734445</phone>
      <email>drritika44@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Post Graduate Institute of Dental Sciences</name>
        <address>
          <city>Rohtak</city>
          <state>Haryana</state>
          <zip>124001</zip>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontal Diseases</mesh_term>
      <mesh_term>Furcation Defects</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06025955
  org study id: Nehaperio123
  nct id: NCT06025955
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The reduced rate of success experienced in the treatment of Furcation involvement (FI) seems
        to result from the incomplete removal of subgingival plaque and calculus in the
        interradicular area owing to the peculiar anatomy of the furcation space.
  
        Regarding the therapeutic approach, although FI treated with a conservative approach may not
        yield the same satisfactory results as single rooted teeth; it has been shown that teeth with
        FI have a remarkable survival rate following conservative treatment in patients demonstrating
        a satisfactory plaque control. Minimally invasive techniques aim to retain the preoperative
        gingival architecture, create a minimal wound and gently handle soft and hard tissues. It
        becomes imperative to see the differences in clinical, and patient centered outcomes of
        minimally invasive non- surgical versus surgical technique in the management of furcation
        involvement in mandibulae molar.
  Patients will be recruited from outpatient clinic of Department of Periodontics, PGIDS,
        Rohtak after screening based on given inclusion and exclusion criteria. after initial session
        of scaling and root planing patient will be re -elevated at the and of 6 to 8 weeks those
        having grade 2 furcation involvement in any mandibular molar and meeting other eligibility
        criteria will be randomly allocated to test group and control group Test group -Experimental
        sites designated to receive non-surgical treatment will be submitted to careful subgingival
        debridement using curettes and ultrasonic device using 3.5 x magnification.
  
        control group-Surgical technique will be followed with minimally flap reflection and
        incisions will be performed with papilla preservation techniques. vertical- releasing
        incisions will not be made, and the full-thickness flap will be minimally elevated. The
        granulation soft tissue will be dissected with a blade and carefully removed with curettes.
        The visible calculus will be carefully removed with curettes and an ultrasonic device. The
        flaps will be re-positioned and sutured and patient follow up 3 to 6 months .
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: change in horizontal clinical attachment level (HCAL)
  time frame: 3 months
  description: change in horizontal clinical attachment level (HCAL) of the furcation as assessed
  measure: change in horizontal clinical attachment level (HCAL)
  time frame: 6 months
  description: change in horizontal clinical attachment level (HCAL) of the furcation as assessed
  measure: changes in vertical probing depth of the furcation
  time frame: 3 months
  description: vertical probing depth will be assessed using UNC 15probe
  measure: changes in vertical probing depth of the furcation
  time frame: 6 months
  description: vertical probing depth will be assessed using UNC 15probe
  measure: change in changes vertical clinical attachment level of furcation
  time frame: 3 months
  description: change clinical vertical attachment will be assessed using UNC 15 probe
  measure: change in vertical clinical attachment level of furcation
  time frame: 6 months
  description: change in vertical clinical attachment level of furcation will be assessed using UNC 15 probe
  measure: probing pocket depth (PPD)reduction
  time frame: 3 months
  description: probing pocket depth (PPD)reduction will be calculated around the molar at 6 sites
  measure: probing pocket depth (PPD)reduction
  time frame: 6 months
  description: probing pocket depth (PPD)reduction will be calculated around the molar at 6 sites
  arm group label: minimally invasive non surgical therapy
  arm group type: Experimental
  description: Experimental sites designated to receive non-surgical treatment will be submitted to careful subgingival debridement using curettes and ultrasonic device using 3.5 x magnification.
  arm group label: open flap debridement
  arm group type: Active Comparator
  description: Surgical technique will be used and the full-thickness flap will be minimally elevated. The granulation soft tissue will be dissected with a blade and carefully removed with curettes.
  intervention type: Procedure
  intervention name: minimally invasive non- surgical therapy
  description: hand and ultrasonic instrumentation will be done
  arm group label: minimally invasive non surgical therapy
  intervention type: Procedure
  intervention name: open flap debridement
  description: flap surgery will be done
  arm group label: open flap debridement
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Neha AGGARWAL, BDS
  role: Principal Investigator
  affiliation: PT BD SHARMA UHSR HARAYANA
  last name: DR. RITIKA ARORA, MDS
  phone: 9810734445
  email: drritika44@gmail.com
  facility: 
  country: India
  responsible party type: Sponsor
  mesh term: Periodontal Diseases
  mesh term: Furcation Defects
  sharing ipd: No