<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/NCT03278054</url>
  </required_header>
  <id_info>
    <org_study_id>seema</org_study_id>
    <nct_id>NCT03278054</nct_id>
  </id_info>
  <brief_title>Effect of Different Instrumentation Technique on Endodontic Outcome</brief_title>
  <official_title>Effect of Different Instrumentation Technique on Outcome of Primary Non Surgical Endodontic Treatment</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>
      Aim: To evaluate and compare the outcome of primary endodontic treatment following use of&#xD;
      different instrumentation techniques.&#xD;
&#xD;
      Materials and methods: Study subjects were recruited from the pool of patients referred for&#xD;
      the non-surgical root canal treatment in the Department of Conservative Dentistry &amp;&#xD;
      Endodontics at PGIDS, Rohtak (Haryana).&#xD;
&#xD;
      The study population comprised of patients requiring primary root canal treatment following&#xD;
      the diagnosis of pulpal necrosis with chronic apical periodontitis in mature mandibular first&#xD;
      and second molars.&#xD;
&#xD;
      Subjects were allocated to one of the three study groups: manual instrumentation, ProTaper&#xD;
      instrumentation and Hybrid instrumentation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AIMS AND OBJECTIVES&#xD;
&#xD;
      The present study has been designed with the following aims and objective:&#xD;
&#xD;
        -  To evaluate the effect of manual / rotary/hybrid instrumentation techniques on success&#xD;
           of primary non surgical root canal treatment in teeth with apical periodontitis.&#xD;
&#xD;
        -  To assess the incidence of postoperative pain in teeth treated with and without rotary&#xD;
           instrumentation.&#xD;
&#xD;
        -  To compare manual, rotary and hybrid instrumentation techniques in terms of periapical&#xD;
           healing in teeth with apical periodontitis.&#xD;
&#xD;
      METHODOLOGY&#xD;
&#xD;
      Prior to treatment a thorough clinical and radiological examination was carried out. A&#xD;
      thorough history was taken from each patient. Prior informed consent was taken after&#xD;
      explaining the procedure, risks and benefits.&#xD;
&#xD;
      Clinical procedure: A total of 90 patients (n=30 in each group) were included in the study.&#xD;
      Mature mandibular permanent molar with diagnosis of apical periodontitis (as confirmed&#xD;
      clinically &amp; by periapical radiograph) were chosen for the study. Patients were randomly&#xD;
      allocated into three groups :Group I- manual instrumentation, Group II -rotary&#xD;
      instrumentation (ProTaper) and Group III -Rotary instrumentation (Hybrid ).&#xD;
&#xD;
      After administration of local anesthesia, rubber dam isolation of the involved tooth was&#xD;
      done. Caries excavation was done and access cavity was prepared using carbide burs in high&#xD;
      speed handpiece with copious irrigation.Debridement of the pulp chamber was done and all&#xD;
      canal orifices were identified. Negotiation of canals was done. Working length was determined&#xD;
      using root ZX apex locator and verified radiographically. Instrumentation was done as&#xD;
      follows.&#xD;
&#xD;
      GROUP A: Manual instrumentation: Hand instrumentation with the stainless steel K files was&#xD;
      performed using step back technique.&#xD;
&#xD;
      GROUP B: Rotary instrumentation (ProTaper files): The cleaning and shaping of the canals was&#xD;
      completed in accordance with a crown down technique recommended by the manufacturer, using&#xD;
      the following operative sequence. Canals were instrumented with ProTaper rotary instruments.&#xD;
      Recapitulation was carried out with size 10 k file.&#xD;
&#xD;
      GROUP C: rotary instrumentation (Hybrid): Roots canals were shaped with a combination of two&#xD;
      NiTi rotary systems: ProTaper Universal instruments were used to shape the coronal and middle&#xD;
      thirds and Hyflex CM files to prepare the apical third.&#xD;
&#xD;
      After completion of canal instrumentation in all the groups, canals were irrigated with 5.0&#xD;
      mL of 17% ethylene-diamine-tetra acetic acid for 1 minute followed by a final irrigation with&#xD;
      5.0 mL of 5.25% sodium hypochlorite. Canals were then be dried with sterile paper points. A&#xD;
      lentulo-spiral was used to fill all canals with a Calcium hydroxide paste and the access&#xD;
      cavity to be restored with intermediate restorative material. The patient were recalled after&#xD;
      1 week. At the second appointment, the calcium hydroxide paste were removed by using&#xD;
      circumferential filing with Hedstrom files and copious irrigation with 5.25% sodium&#xD;
      hypochlorite followed by 5.0 mL of 17% ethylenediaminetetraacetic acid and a final rinse of&#xD;
      5.0 mL 5.25% sodium hypochlorite. Canals were dried with the help of absorbent paper points&#xD;
      and obturated. After obturation, the cavity was permanently restored. Immediate&#xD;
      post-operative radiograph was then taken using preset exposure parameters and processed&#xD;
      manually.&#xD;
&#xD;
      FOLLOW UP&#xD;
&#xD;
      Follow up and clinical and radiographic examination was carried out at 3, 6, 9 &amp; 12 month&#xD;
      period.&#xD;
&#xD;
      Outcome variables&#xD;
&#xD;
        -  The primary outcome variables observed for the study was long term clinical and&#xD;
           radiographic success rates.&#xD;
&#xD;
        -  The secondary outcome measure was the incidence of postoperative pain.&#xD;
&#xD;
      Radiographic success: Radiographic success (change in Periapical Index score) of the root&#xD;
      canal therapy was drawn by comparing the pre-operative; 3 month, 6month, 9 month &amp; 12-month&#xD;
      follow up radiographs.&#xD;
&#xD;
      Clinical success: it was determined by&#xD;
&#xD;
        -  Absence of inter appointment flare ups and pain.&#xD;
&#xD;
        -  Absence of tenderness to palpation /percussion&#xD;
&#xD;
        -  Absence of sinus or any associated soft tissue swelling.&#xD;
&#xD;
        -  Tooth mobility of grade I or less.&#xD;
&#xD;
        -  No deterioration in periodontal pocket depth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2015</start_date>
  <completion_date type="Actual">October 30, 2016</completion_date>
  <primary_completion_date type="Actual">November 30, 2015</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiographic success</measure>
    <time_frame>till 12 month period</time_frame>
    <description>Periapical radiolucency was graded as Periapical Index (PAI) and scores less than 3 were grded as success</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical success</measure>
    <time_frame>12 months</time_frame>
    <description>Absence of pain tenderness sinus or swelling was graded as clinical success</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>every 24 hours for 7 days</time_frame>
    <description>Pain intensity before and after treatment was recorded using 0-100 mm VAS scale</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Apical Periodontitis</condition>
  <arm_group>
    <arm_group_label>Manual group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Root Canal Treatment with hand instruments:Root canal treatment was done with instrumentation using manual K files.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ProTaper group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Root canal treatment with Protaper instruments:Root canal treatment was done using ProTaper rotary files S1, S2, F1, and F2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hybrid group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Root canal treatment with hybrid instrumentation:Root canal treatment was carried out using ProTaper and Hyflex CM files.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Root Canal Treatment with hand instruments</intervention_name>
    <description>Root canal treatment was performed with K files.</description>
    <arm_group_label>Manual group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Root canal treatment with Protaper instruments</intervention_name>
    <description>Root canals were enlarged with S1 S2 F1F2 F2 Protaper instruments</description>
    <arm_group_label>ProTaper group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Root canal treatment with hybrid instrumentation</intervention_name>
    <description>Root canal were enlarged with combination of a combination of ProTaper Universal instruments to shape the coronal and middle thirds and Hyflex CM to prepare the apical third</description>
    <arm_group_label>Hybrid group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient willing to participate in the study.&#xD;
&#xD;
          -  Age greater than 18 years.&#xD;
&#xD;
          -  No history of antibiotic use prior to treatment.&#xD;
&#xD;
          -  Mature permanent mandibular molar having apical periodontitis requiring primary root&#xD;
             canal treatment.&#xD;
&#xD;
          -  There must be a radiographic evidence of periapical radiolucency and a diagnosis of&#xD;
             pulpal necrosis, as confirmed by negative response to cold and electrical tests; and&#xD;
             absence of bleeding on entering the pulp chamber.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Root canal retreatment.&#xD;
&#xD;
          -  Failure to obtain authorization from patients.&#xD;
&#xD;
          -  The presence of a difficult canal anatomy, internal or external resorption and&#xD;
             immature teeth.&#xD;
&#xD;
          -  Accident or complication during treatment like calcified canals, inability to achieve&#xD;
             apical patency in any canals.&#xD;
&#xD;
          -  Immuno-compromised, diabetic, pregnant and hypertensive patients.&#xD;
&#xD;
          -  Periodontally compromised teeth.&#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>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>June 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>apical periodontitis</keyword>
  <keyword>hybrid</keyword>
  <keyword>ProTaper</keyword>
  <keyword>rotary</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Periapical Periodontitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03278054
org study id: seema
nct id: NCT03278054
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aim: To evaluate and compare the outcome of primary endodontic treatment following use of
      different instrumentation techniques.

      Materials and methods: Study subjects were recruited from the pool of patients referred for
      the non-surgical root canal treatment in the Department of Conservative Dentistry &
      Endodontics at PGIDS, Rohtak (Haryana).

      The study population comprised of patients requiring primary root canal treatment following
      the diagnosis of pulpal necrosis with chronic apical periodontitis in mature mandibular first
      and second molars.

      Subjects were allocated to one of the three study groups: manual instrumentation, ProTaper
      instrumentation and Hybrid instrumentation.
AIMS AND OBJECTIVES

      The present study has been designed with the following aims and objective:

        -  To evaluate the effect of manual / rotary/hybrid instrumentation techniques on success
           of primary non surgical root canal treatment in teeth with apical periodontitis.

        -  To assess the incidence of postoperative pain in teeth treated with and without rotary
           instrumentation.

        -  To compare manual, rotary and hybrid instrumentation techniques in terms of periapical
           healing in teeth with apical periodontitis.

      METHODOLOGY

      Prior to treatment a thorough clinical and radiological examination was carried out. A
      thorough history was taken from each patient. Prior informed consent was taken after
      explaining the procedure, risks and benefits.

      Clinical procedure: A total of 90 patients (n=30 in each group) were included in the study.
      Mature mandibular permanent molar with diagnosis of apical periodontitis (as confirmed
      clinically & by periapical radiograph) were chosen for the study. Patients were randomly
      allocated into three groups :Group I- manual instrumentation, Group II -rotary
      instrumentation (ProTaper) and Group III -Rotary instrumentation (Hybrid ).

      After administration of local anesthesia, rubber dam isolation of the involved tooth was
      done. Caries excavation was done and access cavity was prepared using carbide burs in high
      speed handpiece with copious irrigation.Debridement of the pulp chamber was done and all
      canal orifices were identified. Negotiation of canals was done. Working length was determined
      using root ZX apex locator and verified radiographically. Instrumentation was done as
      follows.

      GROUP A: Manual instrumentation: Hand instrumentation with the stainless steel K files was
      performed using step back technique.

      GROUP B: Rotary instrumentation (ProTaper files): The cleaning and shaping of the canals was
      completed in accordance with a crown down technique recommended by the manufacturer, using
      the following operative sequence. Canals were instrumented with ProTaper rotary instruments.
      Recapitulation was carried out with size 10 k file.

      GROUP C: rotary instrumentation (Hybrid): Roots canals were shaped with a combination of two
      NiTi rotary systems: ProTaper Universal instruments were used to shape the coronal and middle
      thirds and Hyflex CM files to prepare the apical third.

      After completion of canal instrumentation in all the groups, canals were irrigated with 5.0
      mL of 17% ethylene-diamine-tetra acetic acid for 1 minute followed by a final irrigation with
      5.0 mL of 5.25% sodium hypochlorite. Canals were then be dried with sterile paper points. A
      lentulo-spiral was used to fill all canals with a Calcium hydroxide paste and the access
      cavity to be restored with intermediate restorative material. The patient were recalled after
      1 week. At the second appointment, the calcium hydroxide paste were removed by using
      circumferential filing with Hedstrom files and copious irrigation with 5.25% sodium
      hypochlorite followed by 5.0 mL of 17% ethylenediaminetetraacetic acid and a final rinse of
      5.0 mL 5.25% sodium hypochlorite. Canals were dried with the help of absorbent paper points
      and obturated. After obturation, the cavity was permanently restored. Immediate
      post-operative radiograph was then taken using preset exposure parameters and processed
      manually.

      FOLLOW UP

      Follow up and clinical and radiographic examination was carried out at 3, 6, 9 & 12 month
      period.

      Outcome variables

        -  The primary outcome variables observed for the study was long term clinical and
           radiographic success rates.

        -  The secondary outcome measure was the incidence of postoperative pain.

      Radiographic success: Radiographic success (change in Periapical Index score) of the root
      canal therapy was drawn by comparing the pre-operative; 3 month, 6month, 9 month & 12-month
      follow up radiographs.

      Clinical success: it was determined by

        -  Absence of inter appointment flare ups and pain.

        -  Absence of tenderness to palpation /percussion

        -  Absence of sinus or any associated soft tissue swelling.

        -  Tooth mobility of grade I or less.

        -  No deterioration in periodontal pocket depth.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Radiographic success
time frame: till 12 month period
description: Periapical radiolucency was graded as Periapical Index (PAI) and scores less than 3 were grded as success
measure: Clinical success
time frame: 12 months
description: Absence of pain tenderness sinus or swelling was graded as clinical success
measure: Pain intensity
time frame: every 24 hours for 7 days
description: Pain intensity before and after treatment was recorded using 0-100 mm VAS scale
arm group label: Manual group
arm group type: Active Comparator
description: Root Canal Treatment with hand instruments:Root canal treatment was done with instrumentation using manual K files.
arm group label: ProTaper group
arm group type: Active Comparator
description: Root canal treatment with Protaper instruments:Root canal treatment was done using ProTaper rotary files S1, S2, F1, and F2.
arm group label: Hybrid group
arm group type: Active Comparator
description: Root canal treatment with hybrid instrumentation:Root canal treatment was carried out using ProTaper and Hyflex CM files.
intervention type: Other
intervention name: Root Canal Treatment with hand instruments
description: Root canal treatment was performed with K files.
arm group label: Manual group
intervention type: Other
intervention name: Root canal treatment with Protaper instruments
description: Root canals were enlarged with S1 S2 F1F2 F2 Protaper instruments
arm group label: ProTaper group
intervention type: Other
intervention name: Root canal treatment with hybrid instrumentation
description: Root canal were enlarged with combination of a combination of ProTaper Universal instruments to shape the coronal and middle thirds and Hyflex CM to prepare the apical third
arm group label: Hybrid group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Periodontitis
mesh term: Periapical Periodontitis
sharing ipd: No