<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/NCT03284736</url>
  </required_header>
  <id_info>
    <org_study_id>pragnesh endo</org_study_id>
    <nct_id>NCT03284736</nct_id>
  </id_info>
  <brief_title>Guided Tissue Regeneration in the Healing of Through and Through Lesions</brief_title>
  <official_title>Effects of Guided Tissue Regeneration on the Healing of Through &amp; Through Periradicular Lesions: A Randomized Controlled 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>
      Study Title: Effects of Guided Tissue Regeneration on the Healing of Through &amp; Through&#xD;
      Periradicular Lesions - A Randomized Controlled Study&#xD;
&#xD;
      Rationale: Through and through defects found to be difficult to heal without GTR&#xD;
      intervention. Various studies has been done either with graft or without graft but no&#xD;
      randomized controlled trial has been done on resorbable membrane(GTR) in through and through&#xD;
      lesion.&#xD;
&#xD;
      Aim &amp; Objectives: To evaluate the effect of resorbable collagen membrane in the healing of&#xD;
      through &amp; through lesion.&#xD;
&#xD;
      Setting: Study was conducted in Post Graduate Institute Of Dental Sciences, Rohtak in the&#xD;
      department of Conservative Dentistry &amp; Endodontics.&#xD;
&#xD;
      Study Design: Randomized Controlled Trial&#xD;
&#xD;
      Time Frame: March 2016 to October 2017&#xD;
&#xD;
      Population / Participants: Patients of age 16 years (male/female) and above were enrolled in&#xD;
      the study.&#xD;
&#xD;
      Inclusion Criteria: Patients of age 16 years and above, -ve response to vitality test, failed&#xD;
      previous root canal treatment with purulent discharge, failed previous surgery, recurrent&#xD;
      episode of purulent discharge.&#xD;
&#xD;
      Exclusion Criteria: Unrestorable tooth, fractured /perforated roots, serious medical illness,&#xD;
      smokers, pregnant females and lactating mothers, grade 3 mobile teeth, the need for&#xD;
      antibiotic prophylaxis prior to dental care.&#xD;
&#xD;
      Sample size: 30 patients (15 patients in each group)&#xD;
&#xD;
      Methods: Clinically and radiographically diagnosis of lesion, vitality check by EPT,&#xD;
      preoperative evaluation by bleeding on probing, clinical attachment level, gingival marginal&#xD;
      position &amp; pocket depth. Surgical procedures will be carried out under operating microscope&#xD;
      with 8 × 16 magnification by following standardized treatment methods.&#xD;
&#xD;
      Outcome measures: Follow up of patients were carried out at 3, 6, 9 &amp; 12 months and outcome&#xD;
      measures were compared with same method done pre operatively and described as Complete&#xD;
      healing, incomplete healing (scar tissue), uncertain healing, unsatisfactory healing&#xD;
      (failure).&#xD;
&#xD;
      Statistical method: Data will be analyzed with suitable statistics method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research process was carried out in the Department Of Conservative Dentistry and&#xD;
      Endodontics, Post Graduate Institute of Dental Sciences, Rohtak. Patients with through and&#xD;
      through periradicular lesions diagnosed radiographically and clinically were be included in&#xD;
      the study.&#xD;
&#xD;
      INCLUSION CRIETERIA :-&#xD;
&#xD;
        1. Patients of age 16 years and above with a clinical &amp; radiographic diagnosis of through&#xD;
           and through periradicular lesion.&#xD;
&#xD;
        2. Negative response to vitality test with radiographic evidence of periapical&#xD;
           rediolucencies.&#xD;
&#xD;
        3. Failed previous root canal treatment with purulent discharge and radiographic evidence&#xD;
           of periapical pathology.&#xD;
&#xD;
        4. Failed previous surgery with persistent bony lesion.&#xD;
&#xD;
        5. Recurrent episode of purulent discharge and adequate final restoration with no clinical&#xD;
           evidence of coronal leakage.&#xD;
&#xD;
      EXCLUSION CRIETERIA :-&#xD;
&#xD;
        1. Unrestorable tooth&#xD;
&#xD;
        2. Fractured /perforated roots&#xD;
&#xD;
        3. Serious medical illness (uncontrolled/poorly controlled diabetes, unstable or life&#xD;
           threatening conditions or requiring antibiotic prophylaxis)&#xD;
&#xD;
        4. Smokers&#xD;
&#xD;
        5. Pregnant females and lactating mothers&#xD;
&#xD;
        6. Grade 3 mobile teeth&#xD;
&#xD;
        7. The need for antibiotic prophylaxis prior to dental care&#xD;
&#xD;
      Baseline parameters --&#xD;
&#xD;
      Endodontic evaluation - Pulp sensibility testing was performed with a combination of heat&#xD;
      test (heated gutta-percha), cold test (Endo-Frost, Coltene Whale dent) and electric pulp test&#xD;
      (Digitestz D626D, Parkell electronics, New York). Teeth not responding to both thermal and&#xD;
      electric test were considered non vital.&#xD;
&#xD;
      Radiographic evaluation - Radiographs with paralleling cone technique was taken at baseline&#xD;
      and at subsequent appointments at standardized exposure parameters (70kvp, 3.5mAs, and 0.2&#xD;
      seconds).&#xD;
&#xD;
      Clinical Periodontal Evaluation - The following clinical parameters were evaluated at&#xD;
      baseline and at subsequent follow up appointments in the test tooth and the contra lateral&#xD;
      normal tooth in the same patient.&#xD;
&#xD;
        1. Bleeding on probing - The presence or absence of bleeding following pocket probing were&#xD;
           recorded at 6 sites per tooth - mesiobuccal, buccal, distobuccal, mesiolingual,&#xD;
           midlingual, distolingual. This assessment was done in full mouth.&#xD;
&#xD;
        2. Probing pocket depth (PPD) - Probing depth was measured as the distance from the&#xD;
           gingival margin to the base of the clinical pocket. The probing depth measurements was&#xD;
           assessed using a calibrated manual periodontal Williams 0 probe. The probe was inserted&#xD;
           with a firm, gentle pressure to the bottom of the pocket and maintained parallel to the&#xD;
           vertical axis of the tooth. Measurements were noted at 6 sites per tooth- mesiobuccal,&#xD;
           midbuccal, distobuccal, mesiolingual, midlingual, distolingual. Measurements will be&#xD;
           rounded to the nearest whole millimeter.&#xD;
&#xD;
        3. Clinical Attachment Level (CAL) - Clinical Attachment Level was measured as the distance&#xD;
           between the base of the clinical pocket and a fixed point on the crown, the&#xD;
           cementoenamel junction (CEJ). Measurements were made at 6 sites per tooth- mesiobuccal,&#xD;
           midbuccal, distobuccal, mesiolingual, midlingual, distolingual using wiliiams 0 probe.&#xD;
           Measurements were rounded to the nearest whole millimeter. The mean CAL over all&#xD;
           examined surfaces were calculated.&#xD;
&#xD;
        4. Gingival marginal level/position from CEJ was measured.Radiographic examination was&#xD;
           performed at 0, 3, 6, 9 and 12 months by using Rinn ( XCP instruments, Elgin, IL )&#xD;
           paralleling technique digitized by using Kodak RVG 6000 ( Kodak Digital Radiographic&#xD;
           System, Pt Husada Intra Care, Banten, Indonesia ).&#xD;
&#xD;
      SAMPLE SIZE&#xD;
&#xD;
      A total number of 15 patients in each group were selected. Sample size was determined by&#xD;
      calculating the difference of success rate between the previous studies of GTR procedures.&#xD;
&#xD;
        1. Test Group: 15 Non vital teeth having through and through periradicular lesion diagnosed&#xD;
           clinically and radiographically first treated with conventional endodontic treatment.&#xD;
           After follow up of one month if no improvement found clinically and radiographically&#xD;
           then apical surgery was carried out using guided tissue regeneration in patients.&#xD;
&#xD;
        2. Control Group: 15 Non vital teeth having through and through periradicular lesion&#xD;
           diagnosed clinically and radiographically first treated with conventional endodontic&#xD;
           treatment. After follow up of one month if no improvement found clinically and&#xD;
           radiographically then apical Surgery was carried out without using guided tissue&#xD;
           regeneration.&#xD;
&#xD;
      RANDOMIZATION&#xD;
&#xD;
      Patients were randomly allocated by computer program [ Random Allocation Software&#xD;
      (http://www.msaghaei.com/Softwares/dnld/RA.zip) ] into two group. Group I=Collagen membrane&#xD;
      group (MG), group II=Control group (CG).&#xD;
&#xD;
      SURGICAL TECHNIQUE:&#xD;
&#xD;
      With the exception of incisions, flap elevation and suturing, all surgical procedures was&#xD;
      performed under operating microscope in an operating room under 8x to 16x magnification.&#xD;
&#xD;
      The full thickness (mucoperiosteal flap) was reflected under aseptic condition by the&#xD;
      following technique&#xD;
&#xD;
        1. Preoperative mouth rinse with 0.2% chlorhexidine mouthwash was used.&#xD;
&#xD;
        2. Local anaesthesia with lidocaine 2% with epinephrine 1:80,000 was achieved.&#xD;
&#xD;
        3. Buccal intrasulcular incision was given up to the alveolar crest including one tooth&#xD;
           mesial to the lesion &amp; two teeth distal to the lesion, using no.15 blade on handle.&#xD;
&#xD;
        4. Mesial and distal vertical releasing incision were given.&#xD;
&#xD;
        5. Full thickness flap was gently reflected towards the apical area by periosteal elevator.&#xD;
           The flap was frequently irrigated with sterile saline to prevent dehydration of&#xD;
           periosteal surface.&#xD;
&#xD;
        6. After complete elevation of the flap, debridement (periradicular curettage -enucleation)&#xD;
           of the bony lesion was performed. For additional hemostasis during surgery, cotton&#xD;
           pellets soaked in 0.1% epinephrine was applied topically as required.&#xD;
&#xD;
        7. A 2-3mm root tip with a 0º to 10º bevel angle was sectioned with cylindrical surgical&#xD;
           carbide burs at high speed with sterile water coolant.&#xD;
&#xD;
        8. Root end preparations extending 3mm into the canal space along the long axis of the root&#xD;
           was made by using a piezoelectric ultrasonic system with double angled Retrotips coated&#xD;
           with Diamond abrasives.&#xD;
&#xD;
        9. Isthmuses, fins, and other significant anatomic irregularities were identified in high&#xD;
           magnification and was treated with the ultrasonic instruments. Then the resected root&#xD;
           surfaces was stained with methylene blue and were inspected with micromirrors under high&#xD;
           magnification of 24x to examine the cleanliness of the root end preparation and detect&#xD;
           any other overlooked anatomic details.&#xD;
&#xD;
       10. Root end filling were with mineral trioxide aggregrate (MTA). The adaptation of the&#xD;
           filling material to the canal apical walls was confirmed with the aid of an operating&#xD;
           microscope at high magnification.&#xD;
&#xD;
       11. After MTA retrofilling in the test group Collagen membrane was applied on buccal side&#xD;
           and in the control group nothing was apllied and flap will be closed with 4-0 reverse&#xD;
           cutting black silk suture.&#xD;
&#xD;
      RESORBABLE COLLAGEN MEMBRANE:&#xD;
&#xD;
      Bioabsorbable membranes are composed of a wide variety of materials including collagen,&#xD;
      polylactic acid, polyurethane, polyglactin 910, acellular dermal matrix, dura mater,&#xD;
      chitosan, periosteum, and calcium sulfate. The most common material is collagen, which can be&#xD;
      modified through various collagen cross-linking processing techniques to vary the resorption&#xD;
      rate.&#xD;
&#xD;
      Numerous studies have shown bioabsorbable membranes to be effective at promoting regeneration&#xD;
      in both endodontic and periodontal defects. Because alveolar bone and the periodontal&#xD;
      ligament contain collagen, using a collagen membrane might impart some additional advantages&#xD;
      for GTR purposes by augmenting its native properties.&#xD;
&#xD;
      Collagen facilitates hemostasis and therefore wound stability by promoting platelet&#xD;
      aggregation in addition to promoting fibroblast migration, which could accelerate wound&#xD;
      closure. After inspecting the root end filled teeth with microscope and radiographically the&#xD;
      defect will be covered with resorbable collage membrane.&#xD;
&#xD;
      Postoperative instructions:&#xD;
&#xD;
      Care must be taken not to over compress the area. patient should rinse with an appropriate&#xD;
      antimicrobial agent of the clinician's choice (chlorhexidine glucoanate) twice daily for two&#xD;
      weeks. patient should avoid brushing the area for 2 weeks from the surgery date, avoid&#xD;
      flossing for 4 weeks from surgery date. following the first 2 weeks from surgery for the next&#xD;
      3 weeks it is recommended to brush the area only with soft brush.&#xD;
&#xD;
      Post - Operative Follow-Up:&#xD;
&#xD;
      Clinical and radiographic examinations were performed every 3, 6 and 12 months by assessing&#xD;
      the same parameters as baseline except that PD, CAL, and GMP were not measured until 12&#xD;
      months. Routine examination procedure was used to evaluate any evidence of signs and/or&#xD;
      symptoms.&#xD;
&#xD;
      Radiographic evaluations:&#xD;
&#xD;
      Jig radiographs will be taken at 3, 6 and 12th month of follow up. Radiographic healing will&#xD;
      be assessed by the criteria as below.&#xD;
&#xD;
        1. Complete healing, defined by re-establishment of the lamina dura&#xD;
&#xD;
        2. Incomplete healing (scar tissue)&#xD;
&#xD;
        3. Uncertain healing&#xD;
&#xD;
        4. Unsatisfactory healing (failure)&#xD;
&#xD;
      Processing Of Data:&#xD;
&#xD;
      Inter and intra observation of data will be analyzed by distribution of data. Categorical&#xD;
      data will be analyzed by chi square test. Regression analysis will be done to observe any&#xD;
      association between independent and dependent variables. Interobserver/intraobserver&#xD;
      reliability with cohen kappa analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Actual">November 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>A total number of 15 patients in each group were selected. Patients were randomly allocated by computer program into two group. Clinical and radiographic examinations were performed every 3, 6 and 12 months by assessing the same parameters as baseline except that PD, CAL, and GMP were measured until 12 months. Routine examination procedure were used to evaluate any evidence of signs and/or symptoms. Jig radiographs were taken at 3, 6 and 12th month of follow up. Inter and intra observation of data will be analyzed by distribution of data. Categorical data will be analyzed by chi square test. Regression analysis will be done to observe any association between independent and dependent variables. Interobserver/intraobserver reliability with cohen kappa analysis.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Both the participant and primary investigator are blinded in the study until whole surgical procedure is completed and before suturing the flap.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in periapical radiolucency by radiograph 1. Complete healing, 2. Incomplete healing 3. Uncertain healing 4. Unsatisfactory healing</measure>
    <time_frame>Baseline to 1 year</time_frame>
    <description>Healing of the lesion will be checked at 3 months interval up to 1 year with the help of software CDR DICOM. At the end of 1 year this reduction in the pathology of lesion will be categorized as complete, incomplete, uncertain, unsatisfactory.&#xD;
Clinical and radiographic examinations will be performed every 3, 6 and 12 months by assessing the same parameters as baseline except that PD, CAL, and GMP will not measured until 12 months.&#xD;
Radiographic evaluations Jig radiographs will be taken at 3, 6 and 12th month of follow up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level</measure>
    <time_frame>Baseline to 1 year</time_frame>
    <description>At the end of 1 year clinical attachment level will be checked of involved teeth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>Baseline to 1 year</time_frame>
    <description>At the end of 1 year probing depth and will be checked of involved teeth.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Periapical Lesions</condition>
  <arm_group>
    <arm_group_label>Periapical surgery with membrane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After retrofilling of teeth with MTA , defect was covered with collagen resorbable membrane.&#xD;
healiguide collagen type 1 resorbable membrane covering the defect by extending 2-3 mm in every direction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Periapical surgery without membrane.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After retrofilling of teeth with MTA, flap was closed without application of collagen resorbable membrane.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Resorbable membrane</intervention_name>
    <arm_group_label>Periapical surgery with membrane</arm_group_label>
    <other_name>Healiguide collagen type 1 resorbable membrane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>periapical surgery without membrane</intervention_name>
    <description>after removing pathology and retro-filling the tooth /teeth wit MTA the defect area is left as it is and flap is closed without resorbable membrane.</description>
    <arm_group_label>Periapical surgery without membrane.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients of age 16 years and above with a clinical &amp; radiographic diagnosis of through&#xD;
             and through periradicular lesion.&#xD;
&#xD;
          2. Negative response to vitality test with radiographic evidence of periapical&#xD;
             rediolucencies.&#xD;
&#xD;
          3. Failed previous root canal treatment with purulent discharge and radiographic evidence&#xD;
             of periapical pathology.&#xD;
&#xD;
          4. Failed previous surgery with persistent bony lesion.&#xD;
&#xD;
          5. Recurrent episode of purulent discharge and adequate final restoration with no&#xD;
             clinical evidence of coronal leakage.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unrestorable tooth&#xD;
&#xD;
          2. Fractured /perforated roots&#xD;
&#xD;
          3. Serious medical illness (uncontrolled/poorly controlled diabetes, unstable or life&#xD;
             threatening conditions or requiring antibiotic prophylaxis)&#xD;
&#xD;
          4. Smokers&#xD;
&#xD;
          5. Pregnant females and lactating mothers&#xD;
&#xD;
          6. Grade 3 mobile teeth&#xD;
&#xD;
          7. The need for antibiotic prophylaxis prior to dental care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03284736
org study id: pragnesh endo
nct id: NCT03284736
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Study Title: Effects of Guided Tissue Regeneration on the Healing of Through & Through
      Periradicular Lesions - A Randomized Controlled Study

      Rationale: Through and through defects found to be difficult to heal without GTR
      intervention. Various studies has been done either with graft or without graft but no
      randomized controlled trial has been done on resorbable membrane(GTR) in through and through
      lesion.

      Aim & Objectives: To evaluate the effect of resorbable collagen membrane in the healing of
      through & through lesion.

      Setting: Study was conducted in Post Graduate Institute Of Dental Sciences, Rohtak in the
      department of Conservative Dentistry & Endodontics.

      Study Design: Randomized Controlled Trial

      Time Frame: March 2016 to October 2017

      Population / Participants: Patients of age 16 years (male/female) and above were enrolled in
      the study.

      Inclusion Criteria: Patients of age 16 years and above, -ve response to vitality test, failed
      previous root canal treatment with purulent discharge, failed previous surgery, recurrent
      episode of purulent discharge.

      Exclusion Criteria: Unrestorable tooth, fractured /perforated roots, serious medical illness,
      smokers, pregnant females and lactating mothers, grade 3 mobile teeth, the need for
      antibiotic prophylaxis prior to dental care.

      Sample size: 30 patients (15 patients in each group)

      Methods: Clinically and radiographically diagnosis of lesion, vitality check by EPT,
      preoperative evaluation by bleeding on probing, clinical attachment level, gingival marginal
      position & pocket depth. Surgical procedures will be carried out under operating microscope
      with 8 × 16 magnification by following standardized treatment methods.

      Outcome measures: Follow up of patients were carried out at 3, 6, 9 & 12 months and outcome
      measures were compared with same method done pre operatively and described as Complete
      healing, incomplete healing (scar tissue), uncertain healing, unsatisfactory healing
      (failure).

      Statistical method: Data will be analyzed with suitable statistics method.
The research process was carried out in the Department Of Conservative Dentistry and
      Endodontics, Post Graduate Institute of Dental Sciences, Rohtak. Patients with through and
      through periradicular lesions diagnosed radiographically and clinically were be included in
      the study.

      INCLUSION CRIETERIA :-

        1. Patients of age 16 years and above with a clinical & radiographic diagnosis of through
           and through periradicular lesion.

        2. Negative response to vitality test with radiographic evidence of periapical
           rediolucencies.

        3. Failed previous root canal treatment with purulent discharge and radiographic evidence
           of periapical pathology.

        4. Failed previous surgery with persistent bony lesion.

        5. Recurrent episode of purulent discharge and adequate final restoration with no clinical
           evidence of coronal leakage.

      EXCLUSION CRIETERIA :-

        1. Unrestorable tooth

        2. Fractured /perforated roots

        3. Serious medical illness (uncontrolled/poorly controlled diabetes, unstable or life
           threatening conditions or requiring antibiotic prophylaxis)

        4. Smokers

        5. Pregnant females and lactating mothers

        6. Grade 3 mobile teeth

        7. The need for antibiotic prophylaxis prior to dental care

      Baseline parameters --

      Endodontic evaluation - Pulp sensibility testing was performed with a combination of heat
      test (heated gutta-percha), cold test (Endo-Frost, Coltene Whale dent) and electric pulp test
      (Digitestz D626D, Parkell electronics, New York). Teeth not responding to both thermal and
      electric test were considered non vital.

      Radiographic evaluation - Radiographs with paralleling cone technique was taken at baseline
      and at subsequent appointments at standardized exposure parameters (70kvp, 3.5mAs, and 0.2
      seconds).

      Clinical Periodontal Evaluation - The following clinical parameters were evaluated at
      baseline and at subsequent follow up appointments in the test tooth and the contra lateral
      normal tooth in the same patient.

        1. Bleeding on probing - The presence or absence of bleeding following pocket probing were
           recorded at 6 sites per tooth - mesiobuccal, buccal, distobuccal, mesiolingual,
           midlingual, distolingual. This assessment was done in full mouth.

        2. Probing pocket depth (PPD) - Probing depth was measured as the distance from the
           gingival margin to the base of the clinical pocket. The probing depth measurements was
           assessed using a calibrated manual periodontal Williams 0 probe. The probe was inserted
           with a firm, gentle pressure to the bottom of the pocket and maintained parallel to the
           vertical axis of the tooth. Measurements were noted at 6 sites per tooth- mesiobuccal,
           midbuccal, distobuccal, mesiolingual, midlingual, distolingual. Measurements will be
           rounded to the nearest whole millimeter.

        3. Clinical Attachment Level (CAL) - Clinical Attachment Level was measured as the distance
           between the base of the clinical pocket and a fixed point on the crown, the
           cementoenamel junction (CEJ). Measurements were made at 6 sites per tooth- mesiobuccal,
           midbuccal, distobuccal, mesiolingual, midlingual, distolingual using wiliiams 0 probe.
           Measurements were rounded to the nearest whole millimeter. The mean CAL over all
           examined surfaces were calculated.

        4. Gingival marginal level/position from CEJ was measured.Radiographic examination was
           performed at 0, 3, 6, 9 and 12 months by using Rinn ( XCP instruments, Elgin, IL )
           paralleling technique digitized by using Kodak RVG 6000 ( Kodak Digital Radiographic
           System, Pt Husada Intra Care, Banten, Indonesia ).

      SAMPLE SIZE

      A total number of 15 patients in each group were selected. Sample size was determined by
      calculating the difference of success rate between the previous studies of GTR procedures.

        1. Test Group: 15 Non vital teeth having through and through periradicular lesion diagnosed
           clinically and radiographically first treated with conventional endodontic treatment.
           After follow up of one month if no improvement found clinically and radiographically
           then apical surgery was carried out using guided tissue regeneration in patients.

        2. Control Group: 15 Non vital teeth having through and through periradicular lesion
           diagnosed clinically and radiographically first treated with conventional endodontic
           treatment. After follow up of one month if no improvement found clinically and
           radiographically then apical Surgery was carried out without using guided tissue
           regeneration.

      RANDOMIZATION

      Patients were randomly allocated by computer program [ Random Allocation Software
      (http://www.msaghaei.com/Softwares/dnld/RA.zip) ] into two group. Group I=Collagen membrane
      group (MG), group II=Control group (CG).

      SURGICAL TECHNIQUE:

      With the exception of incisions, flap elevation and suturing, all surgical procedures was
      performed under operating microscope in an operating room under 8x to 16x magnification.

      The full thickness (mucoperiosteal flap) was reflected under aseptic condition by the
      following technique

        1. Preoperative mouth rinse with 0.2% chlorhexidine mouthwash was used.

        2. Local anaesthesia with lidocaine 2% with epinephrine 1:80,000 was achieved.

        3. Buccal intrasulcular incision was given up to the alveolar crest including one tooth
           mesial to the lesion & two teeth distal to the lesion, using no.15 blade on handle.

        4. Mesial and distal vertical releasing incision were given.

        5. Full thickness flap was gently reflected towards the apical area by periosteal elevator.
           The flap was frequently irrigated with sterile saline to prevent dehydration of
           periosteal surface.

        6. After complete elevation of the flap, debridement (periradicular curettage -enucleation)
           of the bony lesion was performed. For additional hemostasis during surgery, cotton
           pellets soaked in 0.1% epinephrine was applied topically as required.

        7. A 2-3mm root tip with a 0º to 10º bevel angle was sectioned with cylindrical surgical
           carbide burs at high speed with sterile water coolant.

        8. Root end preparations extending 3mm into the canal space along the long axis of the root
           was made by using a piezoelectric ultrasonic system with double angled Retrotips coated
           with Diamond abrasives.

        9. Isthmuses, fins, and other significant anatomic irregularities were identified in high
           magnification and was treated with the ultrasonic instruments. Then the resected root
           surfaces was stained with methylene blue and were inspected with micromirrors under high
           magnification of 24x to examine the cleanliness of the root end preparation and detect
           any other overlooked anatomic details.

       10. Root end filling were with mineral trioxide aggregrate (MTA). The adaptation of the
           filling material to the canal apical walls was confirmed with the aid of an operating
           microscope at high magnification.

       11. After MTA retrofilling in the test group Collagen membrane was applied on buccal side
           and in the control group nothing was apllied and flap will be closed with 4-0 reverse
           cutting black silk suture.

      RESORBABLE COLLAGEN MEMBRANE:

      Bioabsorbable membranes are composed of a wide variety of materials including collagen,
      polylactic acid, polyurethane, polyglactin 910, acellular dermal matrix, dura mater,
      chitosan, periosteum, and calcium sulfate. The most common material is collagen, which can be
      modified through various collagen cross-linking processing techniques to vary the resorption
      rate.

      Numerous studies have shown bioabsorbable membranes to be effective at promoting regeneration
      in both endodontic and periodontal defects. Because alveolar bone and the periodontal
      ligament contain collagen, using a collagen membrane might impart some additional advantages
      for GTR purposes by augmenting its native properties.

      Collagen facilitates hemostasis and therefore wound stability by promoting platelet
      aggregation in addition to promoting fibroblast migration, which could accelerate wound
      closure. After inspecting the root end filled teeth with microscope and radiographically the
      defect will be covered with resorbable collage membrane.

      Postoperative instructions:

      Care must be taken not to over compress the area. patient should rinse with an appropriate
      antimicrobial agent of the clinician's choice (chlorhexidine glucoanate) twice daily for two
      weeks. patient should avoid brushing the area for 2 weeks from the surgery date, avoid
      flossing for 4 weeks from surgery date. following the first 2 weeks from surgery for the next
      3 weeks it is recommended to brush the area only with soft brush.

      Post - Operative Follow-Up:

      Clinical and radiographic examinations were performed every 3, 6 and 12 months by assessing
      the same parameters as baseline except that PD, CAL, and GMP were not measured until 12
      months. Routine examination procedure was used to evaluate any evidence of signs and/or
      symptoms.

      Radiographic evaluations:

      Jig radiographs will be taken at 3, 6 and 12th month of follow up. Radiographic healing will
      be assessed by the criteria as below.

        1. Complete healing, defined by re-establishment of the lamina dura

        2. Incomplete healing (scar tissue)

        3. Uncertain healing

        4. Unsatisfactory healing (failure)

      Processing Of Data:

      Inter and intra observation of data will be analyzed by distribution of data. Categorical
      data will be analyzed by chi square test. Regression analysis will be done to observe any
      association between independent and dependent variables. Interobserver/intraobserver
      reliability with cohen kappa analysis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A total number of 15 patients in each group were selected. Patients were randomly allocated by computer program into two group. Clinical and radiographic examinations were performed every 3, 6 and 12 months by assessing the same parameters as baseline except that PD, CAL, and GMP were measured until 12 months. Routine examination procedure were used to evaluate any evidence of signs and/or symptoms. Jig radiographs were taken at 3, 6 and 12th month of follow up. Inter and intra observation of data will be analyzed by distribution of data. Categorical data will be analyzed by chi square test. Regression analysis will be done to observe any association between independent and dependent variables. Interobserver/intraobserver reliability with cohen kappa analysis.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Both the participant and primary investigator are blinded in the study until whole surgical procedure is completed and before suturing the flap.
measure: Change in periapical radiolucency by radiograph 1. Complete healing, 2. Incomplete healing 3. Uncertain healing 4. Unsatisfactory healing
time frame: Baseline to 1 year
description: Healing of the lesion will be checked at 3 months interval up to 1 year with the help of software CDR DICOM. At the end of 1 year this reduction in the pathology of lesion will be categorized as complete, incomplete, uncertain, unsatisfactory.
Clinical and radiographic examinations will be performed every 3, 6 and 12 months by assessing the same parameters as baseline except that PD, CAL, and GMP will not measured until 12 months.
Radiographic evaluations Jig radiographs will be taken at 3, 6 and 12th month of follow up.
measure: Clinical attachment level
time frame: Baseline to 1 year
description: At the end of 1 year clinical attachment level will be checked of involved teeth.
measure: Probing depth
time frame: Baseline to 1 year
description: At the end of 1 year probing depth and will be checked of involved teeth.
arm group label: Periapical surgery with membrane
arm group type: Experimental
description: After retrofilling of teeth with MTA , defect was covered with collagen resorbable membrane.
healiguide collagen type 1 resorbable membrane covering the defect by extending 2-3 mm in every direction.
arm group label: Periapical surgery without membrane.
arm group type: Active Comparator
description: After retrofilling of teeth with MTA, flap was closed without application of collagen resorbable membrane.
intervention type: Procedure
intervention name: Resorbable membrane
arm group label: Periapical surgery with membrane
other name: Healiguide collagen type 1 resorbable membrane
intervention type: Procedure
intervention name: periapical surgery without membrane
description: after removing pathology and retro-filling the tooth /teeth wit MTA the defect area is left as it is and flap is closed without resorbable membrane.
arm group label: Periapical surgery without membrane.
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: Yes