<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/NCT03230344</url>
  </required_header>
  <id_info>
    <org_study_id>Ruchika perio</org_study_id>
    <nct_id>NCT03230344</nct_id>
  </id_info>
  <brief_title>Periodontal Surgery With Early vs Delayed Endodontic Treatment in Endo-Perio Lesions Without Communication</brief_title>
  <official_title>Surgical Periodontal Intervention With Simultaneous Versus Delayed Endodontic Treatment in Concurrent Endodontic-Periodontal Lesion Without Communication - An Interventional Study</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 aim of this study is to evaluate the periodontal parameters in terms of periodontal&#xD;
      healing by periodontal surgical therapy with simultaneous or delayed endodontic therapy in&#xD;
      management of concurrent endodontic -periodontal lesion without communication&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION&#xD;
&#xD;
      The term &quot; Endodontic-Periodontal &quot; lesion has been proposed to describe the destructive&#xD;
      lesions resulting from inflammatory products found in varying degrees in both the&#xD;
      periodontium and the pulpal tissues. The term concurrent endodontic periodontal lesion&#xD;
      without communication applies to a tooth that has an infected root canal system with some&#xD;
      form of apical periodontitis plus marginal periodontal disease with pocketing but the&#xD;
      periapical and periodontal disease do not communicate with each other.&#xD;
&#xD;
      Although there are many factors, the primary cause of both diseases is the presence of&#xD;
      bacterial infection with complex microbial flora. Based on microbiological studies many&#xD;
      authors have reported the similarity between bacterial flora associated with endodontic and&#xD;
      periodontal infections. Therefore periodontal pocket may be a source of bacteria for root&#xD;
      canal system or vice versa and cross seeding of bacteria can occur in either direction&#xD;
      through communication pathways. An untreated infection of one of these tissues can lead to&#xD;
      signs or symptoms of disease within the other tissue.&#xD;
&#xD;
      Observations based upon review articles and case reports has suggested, if the root canal&#xD;
      system is infected, endodontic treatment should be commenced prior to any periodontal therapy&#xD;
      in order to remove the intra-canal infection before any cementum is removed in case of&#xD;
      concurrent endodontic - periodontal lesions without communication. Treatment results of&#xD;
      endodontic therapy should be evaluated in 2-3 months and only then periodontal treatment&#xD;
      should be considered.&#xD;
&#xD;
      Concerns about the possibility that endodontically treated teeth might not respond to&#xD;
      periodontal therapy are certainly not new. Histological examination of human teeth concluded&#xD;
      that endodontic therapy had adversely affected periodontal healing. Teeth that had undergone&#xD;
      endodontic therapy did not respond well to regenerative procedures as teeth that had not&#xD;
      undergone such treatment. It has been advocated to perform periodontal therapy before&#xD;
      endodontic obturation because of the concern that the leakage of endodontic sealer would&#xD;
      hinder repair, regeneration or both. There is a negative impact of certain root canal filling&#xD;
      materials on fibroblast attachment to the dentin surface of extracted third molars. Also&#xD;
      endodontic therapy performed simultaneously with or soon after periodontal surgery adversely&#xD;
      affected the formation of new bone, new cementum and new attachment. It was also found in a&#xD;
      study that periapical pathology was not significantly correlated to mean pocket depth&#xD;
      reduction after non surgical and surgical treatment of horizontal and vertical defects .&#xD;
&#xD;
      The microflora in infected root canals of teeth that have concurrent endodontic and&#xD;
      periodontal diseases is more complex than in teeth with infection confined to the periapical&#xD;
      region.&#xD;
&#xD;
      All the above findings are based on microbiological, histological, case-reports,&#xD;
      retrospective and in vitro studies, management of concurrent endodontic periodontal lesions&#xD;
      need more evidence based investigations. So far no clinical study has compared periodontal&#xD;
      healing along with or without endodontic therapy. It is hypothesized that endodontic&#xD;
      treatment did not influence the periodontal outcomes after periodontal surgery in&#xD;
      endodontic-periodontal lesion without communication.&#xD;
&#xD;
      Thus the aim of our study is to evaluate the periodontal parameters in terms of periodontal&#xD;
      healing by periodontal surgical therapy with simultaneous or delayed endodontic therapy in&#xD;
      management of concurrent endodontic -periodontal lesion without communication.&#xD;
&#xD;
      MATERIAL AND METHOD&#xD;
&#xD;
      This study will be conducted in Department of Periodontics and Oral Implantology in&#xD;
      collaboration with Department of Conservative Dentistry and Endodontics, Post Graduate&#xD;
      Institute of Dental Sciences , Rohtak.&#xD;
&#xD;
      STUDY POPULATION Patients will be recruited from regular out patient department of the&#xD;
      Department of Periodontics and Oral Implantology, Department of Conservative Dentistry &amp;&#xD;
      Endodontics and Department of Oral medicine, Diagnosis and Radiology.The study will be&#xD;
      conducted as follows:- This Interventional study will include systemically healthy minimum 36&#xD;
      patients with chronic periodontitis having at least one tooth involving endodontic&#xD;
      periodontal lesion which will be further divided into two groups (minimum 18 each) based on&#xD;
      patient's consent for treatment.&#xD;
&#xD;
        1. Simultaneous endodontic periodontal therapy group (Group 1) Scaling and root planning&#xD;
           will be performed simultaneously with non surgical endodontic treatment (in the form of&#xD;
           root canal treatment). After 6 weeks of scaling and root planning , periodontal surgery&#xD;
           will be performed in the form of open flap debridement.&#xD;
&#xD;
        2. Delayed endodontic therapy group (Group 2) Periodontal treatment initiated with scaling&#xD;
           and root planning followed by periodontal surgery in the form of open flap debridement&#xD;
           after 6 weeks. Endodontic treatment will be initiated after 3 months of periodontal&#xD;
           surgery.&#xD;
&#xD;
      Prior informed consent will be taken from each patient after explaining the procedure in&#xD;
      patient's language along with risk and benefits involved.&#xD;
&#xD;
      METHODOLOGY Patients will be allocated to group1 and group 2. The study will be conducted as&#xD;
      follows:- Presurgical therapy:- which will be including&#xD;
&#xD;
      i. Oral hygiene instructions ii. Full mouth supragingival and subgingival scaling and root&#xD;
      planning with ultrasonic scaler, hand scaler and curettes.&#xD;
&#xD;
      iii. In group 1 conventional root canal therapy will be performed simultaneously to&#xD;
      presurgical therapy.&#xD;
&#xD;
      Surgical therapy:- In both groups periodontal surgical procedure in the form of open flap&#xD;
      debridement will be performed after 6 weeks of SRP.&#xD;
&#xD;
      A probing stent will be fabricated for every patient,relative to which attachment loss will&#xD;
      be measured.&#xD;
&#xD;
      In group 2 conventional root canal therapy will be performed 3 months after periodontal&#xD;
      surgical procedure.&#xD;
&#xD;
      CLINICAL PARAMETERS&#xD;
&#xD;
        1. Full mouth indices to be recorded at baseline&#xD;
&#xD;
             -  Bleeding on probing&#xD;
&#xD;
             -  Probing Pocket depth&#xD;
&#xD;
             -  Attachment loss&#xD;
&#xD;
        2. Site specific indices&#xD;
&#xD;
             -  Plaque index&#xD;
&#xD;
             -  Gingival index&#xD;
&#xD;
             -  Probing Pocket depth&#xD;
&#xD;
             -  Relative attachment loss&#xD;
&#xD;
             -  Bleeding on probing&#xD;
&#xD;
             -  Tooth mobility&#xD;
&#xD;
             -  Relative gingival marginal level Using UNC 15 periodontal probe at 6 sites (mesial,&#xD;
                distal, median points at buccal and lingual aspects) per tooth.&#xD;
&#xD;
      Customized bite blocks and parallel angle technique will be used to obtain radiographs.&#xD;
&#xD;
      Clinical parameters will be recorded at baseline, at 6 weeks of nonsurgical phase, at 3&#xD;
      months and after 6 months post surgery for Group 1(6 months of periodontal surgery and&#xD;
      endodontic treatment) and group 2 (6 months of periodontal surgery and 3 months of root canal&#xD;
      treatment).&#xD;
&#xD;
      PERIODONTAL NON SURGICAL PROCEDURE This involves supragingival and subgingival scaling and&#xD;
      root planning to be performed with ultrasonic scaler, hand scaler and curette and will be&#xD;
      completed in minimum two sessions.&#xD;
&#xD;
      PERIODONTAL SURGICAL PROCEDURE After administration of local anaesthesia, buccal and&#xD;
      lingual/palatal intracrevicular incision will be made and mucoperiosteal flaps will be&#xD;
      reflected including atleast one tooth ahead and another behind the tooth. Meticulous defect&#xD;
      debridement and root planning will be carried out using area specific curettes and scalers&#xD;
      with special effort to remove all the granulation tissue. After instrumentation, the root&#xD;
      surfaces will be washed with saline solution in attempt to remove any remaining detached&#xD;
      fragments from the defect and surgical field. After debridement mucoperiosteal flaps will be&#xD;
      repositioned and secured by using 3-0 non absorbable black silk surgical suture. The surgical&#xD;
      area will be protected and covered with periodontal dressing and post operative instructions&#xD;
      will be given.&#xD;
&#xD;
      -Instructions will be given for gentle brushing with soft brush and reinstructed for proper&#xD;
      oral hygiene postoperatively and will be examined weekly for up to 1 month after surgery and&#xD;
      again at 3 month.&#xD;
&#xD;
      CONVENTIONAL ENDODONTIC PROCEDURE After achieving local anaesthesia, access opening will be&#xD;
      made with the help of round bur. Then the root canal will be thoroughly debrided followed by&#xD;
      copious irrigation and subsequently prepared with the help of endo files. After preparation&#xD;
      of the canal, calcium hydroxide intracanal medicament will be placed with the help of 27&#xD;
      gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer.&#xD;
      Obturation will be performed with gutta percha and zinc oxide eugenol based sealer.&#xD;
&#xD;
      -All parameters will be re-evaluated at recall period of 6 weeks, 3 months and 6 months for&#xD;
      Group 1 (conventional endodontic periodontal therapy group) and group 2 (delayed endodontic&#xD;
      therapy group).&#xD;
&#xD;
      STATISTICAL ANALYSIS&#xD;
&#xD;
      Data recorded will be processed by standard statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Anticipated">April 2018</completion_date>
  <primary_completion_date type="Anticipated">April 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>periodontal parameter: CAL</measure>
    <time_frame>7.5 months</time_frame>
    <description>Clinical attachment level</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Periodontal and Endodontic Lesion</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Periodontal treatment initiated with scaling and root planing along with root canal treatment and followed by open flap debridement after 6 weeks.(Open flap debridement simultaneously with root canal treatment )</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Periodontal treatment initiated with scaling and root planing followed by open flap debridement after 6 weeks. Endodontic treatment will be initiated after 3 months of periodontal surgery.(open flap debridement and delayed root canal treatment )</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>open flap debridement</intervention_name>
    <description>open flap debridement simultaneously with root canal treatment</description>
    <arm_group_label>Group 1</arm_group_label>
    <other_name>root canal treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>open flap debridement</intervention_name>
    <description>open flap debridement and delayed root canal treatment</description>
    <arm_group_label>Group 2</arm_group_label>
    <other_name>root canal treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients of age 18 years and above, systematically healthy with chronic periodontitis&#xD;
        having at least one tooth involving endodontic periodontal lesion without apical&#xD;
        communication with following radiographic and clinical features:&#xD;
&#xD;
          -  Wide base pocket, deep pocket depth&#xD;
&#xD;
          -  Non vital tooth (confirmed by heat test, cold test and electronic pulp test)&#xD;
&#xD;
          -  Radiographic periapical alveolar bone destruction and marginal bone loss without&#xD;
             apical communication .&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        :• Systemic illness known to affect the periodontium or outcome of periodontal therapy.&#xD;
&#xD;
          -  Patient taking medications such as corticosteroids or calcium channel blockers, which&#xD;
             are known to interfere periodontal wound healing or patient on long term NSAID&#xD;
             therapy.&#xD;
&#xD;
          -  Patients allergic to medication (local anaesthetic, antibiotics, NSAID).&#xD;
&#xD;
          -  Pregnant or lactating mothers.&#xD;
&#xD;
          -  Smokers and tobacco chewers.&#xD;
&#xD;
          -  Grade 3 mobile teeth.&#xD;
&#xD;
          -  Unrestorable tooth.&#xD;
&#xD;
          -  Fractured/perforated roots.&#xD;
&#xD;
          -  Developing permanent tooth.&#xD;
&#xD;
          -  Previously root canal filled.&#xD;
&#xD;
          -  History of recent periodontal treatment within 6 months prior to study.&#xD;
&#xD;
          -  Teeth with established endodontic periodontal lesions exhibiting &lt;2mm radioopaque bone&#xD;
             between the root apex and the periodontal breakdown and with apical communication&#xD;
             found during surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>RUCHIKA LATHER</last_name>
    <role>Principal Investigator</role>
    <affiliation>POST GRADUATE INSTITUTE OF DENTAL SCIENCES</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>TEWARI</last_name>
    <phone>9416514600</phone>
    <email>drshikhatewari@yahoo.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>
    <status>Recruiting</status>
    <contact>
      <last_name>TEWARI</last_name>
      <phone>01262283876</phone>
      <email>principalpgids@yahoo.in</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 23, 2017</last_update_submitted>
  <last_update_submitted_qc>July 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>1yr 6months</ipd_time_frame>
    <ipd_access_criteria>PGIDS, Rohtak Haryana</ipd_access_criteria>
  </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/NCT03230344
org study id: Ruchika perio
nct id: NCT03230344
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the periodontal parameters in terms of periodontal
      healing by periodontal surgical therapy with simultaneous or delayed endodontic therapy in
      management of concurrent endodontic -periodontal lesion without communication
INTRODUCTION

      The term " Endodontic-Periodontal " lesion has been proposed to describe the destructive
      lesions resulting from inflammatory products found in varying degrees in both the
      periodontium and the pulpal tissues. The term concurrent endodontic periodontal lesion
      without communication applies to a tooth that has an infected root canal system with some
      form of apical periodontitis plus marginal periodontal disease with pocketing but the
      periapical and periodontal disease do not communicate with each other.

      Although there are many factors, the primary cause of both diseases is the presence of
      bacterial infection with complex microbial flora. Based on microbiological studies many
      authors have reported the similarity between bacterial flora associated with endodontic and
      periodontal infections. Therefore periodontal pocket may be a source of bacteria for root
      canal system or vice versa and cross seeding of bacteria can occur in either direction
      through communication pathways. An untreated infection of one of these tissues can lead to
      signs or symptoms of disease within the other tissue.

      Observations based upon review articles and case reports has suggested, if the root canal
      system is infected, endodontic treatment should be commenced prior to any periodontal therapy
      in order to remove the intra-canal infection before any cementum is removed in case of
      concurrent endodontic - periodontal lesions without communication. Treatment results of
      endodontic therapy should be evaluated in 2-3 months and only then periodontal treatment
      should be considered.

      Concerns about the possibility that endodontically treated teeth might not respond to
      periodontal therapy are certainly not new. Histological examination of human teeth concluded
      that endodontic therapy had adversely affected periodontal healing. Teeth that had undergone
      endodontic therapy did not respond well to regenerative procedures as teeth that had not
      undergone such treatment. It has been advocated to perform periodontal therapy before
      endodontic obturation because of the concern that the leakage of endodontic sealer would
      hinder repair, regeneration or both. There is a negative impact of certain root canal filling
      materials on fibroblast attachment to the dentin surface of extracted third molars. Also
      endodontic therapy performed simultaneously with or soon after periodontal surgery adversely
      affected the formation of new bone, new cementum and new attachment. It was also found in a
      study that periapical pathology was not significantly correlated to mean pocket depth
      reduction after non surgical and surgical treatment of horizontal and vertical defects .

      The microflora in infected root canals of teeth that have concurrent endodontic and
      periodontal diseases is more complex than in teeth with infection confined to the periapical
      region.

      All the above findings are based on microbiological, histological, case-reports,
      retrospective and in vitro studies, management of concurrent endodontic periodontal lesions
      need more evidence based investigations. So far no clinical study has compared periodontal
      healing along with or without endodontic therapy. It is hypothesized that endodontic
      treatment did not influence the periodontal outcomes after periodontal surgery in
      endodontic-periodontal lesion without communication.

      Thus the aim of our study is to evaluate the periodontal parameters in terms of periodontal
      healing by periodontal surgical therapy with simultaneous or delayed endodontic therapy in
      management of concurrent endodontic -periodontal lesion without communication.

      MATERIAL AND METHOD

      This study will be conducted in Department of Periodontics and Oral Implantology in
      collaboration with Department of Conservative Dentistry and Endodontics, Post Graduate
      Institute of Dental Sciences , Rohtak.

      STUDY POPULATION Patients will be recruited from regular out patient department of the
      Department of Periodontics and Oral Implantology, Department of Conservative Dentistry &
      Endodontics and Department of Oral medicine, Diagnosis and Radiology.The study will be
      conducted as follows:- This Interventional study will include systemically healthy minimum 36
      patients with chronic periodontitis having at least one tooth involving endodontic
      periodontal lesion which will be further divided into two groups (minimum 18 each) based on
      patient's consent for treatment.

        1. Simultaneous endodontic periodontal therapy group (Group 1) Scaling and root planning
           will be performed simultaneously with non surgical endodontic treatment (in the form of
           root canal treatment). After 6 weeks of scaling and root planning , periodontal surgery
           will be performed in the form of open flap debridement.

        2. Delayed endodontic therapy group (Group 2) Periodontal treatment initiated with scaling
           and root planning followed by periodontal surgery in the form of open flap debridement
           after 6 weeks. Endodontic treatment will be initiated after 3 months of periodontal
           surgery.

      Prior informed consent will be taken from each patient after explaining the procedure in
      patient's language along with risk and benefits involved.

      METHODOLOGY Patients will be allocated to group1 and group 2. The study will be conducted as
      follows:- Presurgical therapy:- which will be including

      i. Oral hygiene instructions ii. Full mouth supragingival and subgingival scaling and root
      planning with ultrasonic scaler, hand scaler and curettes.

      iii. In group 1 conventional root canal therapy will be performed simultaneously to
      presurgical therapy.

      Surgical therapy:- In both groups periodontal surgical procedure in the form of open flap
      debridement will be performed after 6 weeks of SRP.

      A probing stent will be fabricated for every patient,relative to which attachment loss will
      be measured.

      In group 2 conventional root canal therapy will be performed 3 months after periodontal
      surgical procedure.

      CLINICAL PARAMETERS

        1. Full mouth indices to be recorded at baseline

             -  Bleeding on probing

             -  Probing Pocket depth

             -  Attachment loss

        2. Site specific indices

             -  Plaque index

             -  Gingival index

             -  Probing Pocket depth

             -  Relative attachment loss

             -  Bleeding on probing

             -  Tooth mobility

             -  Relative gingival marginal level Using UNC 15 periodontal probe at 6 sites (mesial,
                distal, median points at buccal and lingual aspects) per tooth.

      Customized bite blocks and parallel angle technique will be used to obtain radiographs.

      Clinical parameters will be recorded at baseline, at 6 weeks of nonsurgical phase, at 3
      months and after 6 months post surgery for Group 1(6 months of periodontal surgery and
      endodontic treatment) and group 2 (6 months of periodontal surgery and 3 months of root canal
      treatment).

      PERIODONTAL NON SURGICAL PROCEDURE This involves supragingival and subgingival scaling and
      root planning to be performed with ultrasonic scaler, hand scaler and curette and will be
      completed in minimum two sessions.

      PERIODONTAL SURGICAL PROCEDURE After administration of local anaesthesia, buccal and
      lingual/palatal intracrevicular incision will be made and mucoperiosteal flaps will be
      reflected including atleast one tooth ahead and another behind the tooth. Meticulous defect
      debridement and root planning will be carried out using area specific curettes and scalers
      with special effort to remove all the granulation tissue. After instrumentation, the root
      surfaces will be washed with saline solution in attempt to remove any remaining detached
      fragments from the defect and surgical field. After debridement mucoperiosteal flaps will be
      repositioned and secured by using 3-0 non absorbable black silk surgical suture. The surgical
      area will be protected and covered with periodontal dressing and post operative instructions
      will be given.

      -Instructions will be given for gentle brushing with soft brush and reinstructed for proper
      oral hygiene postoperatively and will be examined weekly for up to 1 month after surgery and
      again at 3 month.

      CONVENTIONAL ENDODONTIC PROCEDURE After achieving local anaesthesia, access opening will be
      made with the help of round bur. Then the root canal will be thoroughly debrided followed by
      copious irrigation and subsequently prepared with the help of endo files. After preparation
      of the canal, calcium hydroxide intracanal medicament will be placed with the help of 27
      gauge endodontic syringe for 10 days and access cavity will be sealed with suitable sealer.
      Obturation will be performed with gutta percha and zinc oxide eugenol based sealer.

      -All parameters will be re-evaluated at recall period of 6 weeks, 3 months and 6 months for
      Group 1 (conventional endodontic periodontal therapy group) and group 2 (delayed endodontic
      therapy group).

      STATISTICAL ANALYSIS

      Data recorded will be processed by standard statistical analysis.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: periodontal parameter: CAL
time frame: 7.5 months
description: Clinical attachment level
arm group label: Group 1
arm group type: Active Comparator
description: Periodontal treatment initiated with scaling and root planing along with root canal treatment and followed by open flap debridement after 6 weeks.(Open flap debridement simultaneously with root canal treatment )
arm group label: Group 2
arm group type: Experimental
description: Periodontal treatment initiated with scaling and root planing followed by open flap debridement after 6 weeks. Endodontic treatment will be initiated after 3 months of periodontal surgery.(open flap debridement and delayed root canal treatment )
intervention type: Procedure
intervention name: open flap debridement
description: open flap debridement simultaneously with root canal treatment
arm group label: Group 1
other name: root canal treatment
intervention type: Procedure
intervention name: open flap debridement
description: open flap debridement and delayed root canal treatment
arm group label: Group 2
other name: root canal treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: RUCHIKA LATHER
role: Principal Investigator
affiliation: POST GRADUATE INSTITUTE OF DENTAL SCIENCES
last name: TEWARI
phone: 9416514600
email: drshikhatewari@yahoo.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Publication
ipd info type: Study Protocol
ipd time frame: 1yr 6months
ipd access criteria: PGIDS, Rohtak Haryana