<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/NCT03277404</url>
  </required_header>
  <id_info>
    <org_study_id>Jyoti Rana</org_study_id>
    <nct_id>NCT03277404</nct_id>
  </id_info>
  <brief_title>Effect of Smear Layer on Endodontic Outcome</brief_title>
  <official_title>Effect of Smear Layer on Endodontic Outcome: A 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>
      This study evaluated the effect of removal of smear layer on the success of primary root&#xD;
      canal treatment.Patients requiring primary root canal treatment in mature mandibular first&#xD;
      and second molars were allocated to either smear layer positive group and smear layer&#xD;
      negative group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients requiring primary root canal treatment following the diagnosis of pulp necrosis in&#xD;
      permanent mandibular first and second molars having radiographic evidence of periapical&#xD;
      radiolucency (minimum size ≥ 2.0 × 2.0 mm) were included in the study. All patients were over&#xD;
      18 years of age and diagnosis of pulpal necrosis was confirmed by negative response to cold&#xD;
      and electrical tests, and absence of bleeding on entering the pulp chamber. Patients with&#xD;
      systemic illness, history of analgesic intake within past 7 days, antibiotics in the last&#xD;
      3months and patients who were pregnant were excluded from the study. Periodontally&#xD;
      compromised teeth, previously accessed teeth, teeth that were not suitable for rubber dam&#xD;
      isolation were also excluded from the study.&#xD;
&#xD;
      Subjects were allocated to one of the two study groups: smear layer positive group (only&#xD;
      2.5%NaOCl was used) - SP and smear layer negative group (17% EDTA+2.5%NaOCl was used) - SN.&#xD;
      Using an equal proportion randomization allocation ratio, patients were assigned to the two&#xD;
      groups using envelopes containing concealed assignment codes. It was ensured that neither the&#xD;
      patient, nor the primary investigator was aware of the group till the time of final rinse.&#xD;
&#xD;
      After administration of local anesthesia, rubber dam isolation of the involved tooth was&#xD;
      done. Caries was excavated and access cavity prepared using carbide burs in high speed&#xD;
      handpiece with copious irrigation.Debridement of the pulp chamber was done and all canal&#xD;
      orifices identified.Working length was obtained with the help of electronic apex locator and&#xD;
      confirmed radiographically.Hand files number 10, 15 and 20 were used till working length (WL)&#xD;
      to prepare a smooth reproducible glide path.Canal preparation was done with the help of&#xD;
      rotary NiTi files. In both groups, 2.5% sodium hypochlorite was used as irrigant after each&#xD;
      instrument. All the irrigation procedures were performed using a 27 gauge side vented needle.&#xD;
      After root canal instrumentation, 17% Ethylenediaminetetraacetic acid (EDTA) solution was&#xD;
      also used to remove smear layer in smear layer negative group, while teeth in smear layer&#xD;
      positive group was simply rinsed with 2.5% sodium hypochlorite. In both the groups ultrasonic&#xD;
      activation of irrigant was done. An inter-appointment dressing of calcium hydroxide was&#xD;
      given. The access cavity was then restored with intermediate restorative material (Dental&#xD;
      Products of India).&#xD;
&#xD;
      Patients were prescribed Ibuprofen 400mg with the instructions to take one tablet every 8&#xD;
      hours in the event of pain.Patients were asked to record the severity of pain using 10 cm VAS&#xD;
      scale with 0 depicting no pain and 10 depicting maximum pain imaginable. Patients were asked&#xD;
      to make a mark on the line that represented their level of perceived pain every 24hrs for 7&#xD;
      days following intervention.&#xD;
&#xD;
      One week later, patients returned with the completed questionnaires.&#xD;
&#xD;
      At the same appointment the intracanal dressing was removed with H-files and copious&#xD;
      irrigation with 2.5% NaOCl in both the groups.&#xD;
&#xD;
      17% EDTA solution was used to remove smear layer in smear layer negative group, followed by&#xD;
      2.5% NaOCl while teeth in smear layer positive group were simply rinsed with 2.5% sodium&#xD;
      hypochlorite.&#xD;
&#xD;
      Ultrasonic activation of irrigant was done and canals were obturated with the GuttaPercha and&#xD;
      Zinc Oxide-Eugenol based sealer in both the groups. After obturation, the cavity was restored&#xD;
      permanently.Immediate post-operative radiograph was then taken using preset exposure&#xD;
      parameters.Follow up clinical and radiographic examination was carried out every 3 months,&#xD;
      till a 12 month period. The data gathered was analyzed using suitable statistical methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 7, 2015</start_date>
  <completion_date type="Actual">November 30, 2015</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiographic success</measure>
    <time_frame>every 3 months till 12 month period</time_frame>
    <description>Size of apical radiolucency were scored according to PAI scores and PAI score less than 3 were considered as success</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical success</measure>
    <time_frame>till 12 months</time_frame>
    <description>Presence or absence of any clinical symptoms such as pain,tenderness, sinus tract and swelling</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>Patients were asked to make a mark on the line that represented their level of perceived pain every 24hrs for7 days following intervention</time_frame>
    <description>Pain intensity before and after treatment. Intensity of pain was recorded using 10 cm VAS scale with 0 depicting no pain and 10 depicting maximum pain imaginable.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Apical Periodontitis</condition>
  <arm_group>
    <arm_group_label>Smear Layer Positive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Root canal treatment without smear layer removal: Root canal treatment and Irrigation with 1 ml of 2.5% sodium' hypochlorite for 1 min, followed by ultrasonic activation of 3 ml of 2.5% sodium hypochlorite for 1minute.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smear layer negative</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>root canal treatment with smear layer removal:Root canal treatment and Irrigation with 1 mL of 17% EDTA solution and ultrasonic activation, followed by ultrasonic activation of 3 ml of 2.5% sodium hypochlorite for 1 minute.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Root canal treatment with smear layer removal</intervention_name>
    <description>Canal were irrigated with Naocl and EDTA to remove smear layer</description>
    <arm_group_label>Smear layer negative</arm_group_label>
    <other_name>irrigation with EDTA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Root canal treatment without smear layer removal</intervention_name>
    <description>only sodium hypochlorite was used for irrigation</description>
    <arm_group_label>Smear Layer Positive</arm_group_label>
    <other_name>irrigation with only NAOCL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mature permanent mandibular first and second molars requiring primary root canal&#xD;
             treatment&#xD;
&#xD;
          -  Diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical&#xD;
             tests; and absence of bleeding on entering the pulp chamber&#xD;
&#xD;
          -  Radiographic evidence of periapical radiolucency (minimum size ≥ 2.0 × 2.0 mm)&#xD;
&#xD;
          -  Patient's age more than 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not provide consent for participation in the study&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Positive history of antibiotic use within past one month of the treatment&#xD;
&#xD;
          -  Patients who are pregnant, diabetic, immunocompromised, had serious medical illness or&#xD;
             required antibiotic premedication&#xD;
&#xD;
          -  Patients with pockets ≥4mm or having marginal or furcal bone loss due to periodontitis&#xD;
&#xD;
          -  Teeth that are not suitable for rubber dam isolation&#xD;
&#xD;
          -  Previously accessed teeth and/or with procedural errors&#xD;
&#xD;
          -  Unrestorable tooth, fractured/ perforated roots, inflammatory root resorption&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>June 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 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>EDTA</keyword>
  <keyword>Postoperative pain</keyword>
  <keyword>Pulp necrosis</keyword>
  <keyword>Smear layer</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>
    <mesh_term>Smear Layer</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/NCT03277404
org study id: Jyoti Rana
nct id: NCT03277404
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluated the effect of removal of smear layer on the success of primary root
      canal treatment.Patients requiring primary root canal treatment in mature mandibular first
      and second molars were allocated to either smear layer positive group and smear layer
      negative group.
Patients requiring primary root canal treatment following the diagnosis of pulp necrosis in
      permanent mandibular first and second molars having radiographic evidence of periapical
      radiolucency (minimum size ≥ 2.0 × 2.0 mm) were included in the study. All patients were over
      18 years of age and diagnosis of pulpal necrosis was confirmed by negative response to cold
      and electrical tests, and absence of bleeding on entering the pulp chamber. Patients with
      systemic illness, history of analgesic intake within past 7 days, antibiotics in the last
      3months and patients who were pregnant were excluded from the study. Periodontally
      compromised teeth, previously accessed teeth, teeth that were not suitable for rubber dam
      isolation were also excluded from the study.

      Subjects were allocated to one of the two study groups: smear layer positive group (only
      2.5%NaOCl was used) - SP and smear layer negative group (17% EDTA+2.5%NaOCl was used) - SN.
      Using an equal proportion randomization allocation ratio, patients were assigned to the two
      groups using envelopes containing concealed assignment codes. It was ensured that neither the
      patient, nor the primary investigator was aware of the group till the time of final rinse.

      After administration of local anesthesia, rubber dam isolation of the involved tooth was
      done. Caries was excavated and access cavity prepared using carbide burs in high speed
      handpiece with copious irrigation.Debridement of the pulp chamber was done and all canal
      orifices identified.Working length was obtained with the help of electronic apex locator and
      confirmed radiographically.Hand files number 10, 15 and 20 were used till working length (WL)
      to prepare a smooth reproducible glide path.Canal preparation was done with the help of
      rotary NiTi files. In both groups, 2.5% sodium hypochlorite was used as irrigant after each
      instrument. All the irrigation procedures were performed using a 27 gauge side vented needle.
      After root canal instrumentation, 17% Ethylenediaminetetraacetic acid (EDTA) solution was
      also used to remove smear layer in smear layer negative group, while teeth in smear layer
      positive group was simply rinsed with 2.5% sodium hypochlorite. In both the groups ultrasonic
      activation of irrigant was done. An inter-appointment dressing of calcium hydroxide was
      given. The access cavity was then restored with intermediate restorative material (Dental
      Products of India).

      Patients were prescribed Ibuprofen 400mg with the instructions to take one tablet every 8
      hours in the event of pain.Patients were asked to record the severity of pain using 10 cm VAS
      scale with 0 depicting no pain and 10 depicting maximum pain imaginable. Patients were asked
      to make a mark on the line that represented their level of perceived pain every 24hrs for 7
      days following intervention.

      One week later, patients returned with the completed questionnaires.

      At the same appointment the intracanal dressing was removed with H-files and copious
      irrigation with 2.5% NaOCl in both the groups.

      17% EDTA solution was used to remove smear layer in smear layer negative group, followed by
      2.5% NaOCl while teeth in smear layer positive group were simply rinsed with 2.5% sodium
      hypochlorite.

      Ultrasonic activation of irrigant was done and canals were obturated with the GuttaPercha and
      Zinc Oxide-Eugenol based sealer in both the groups. After obturation, the cavity was restored
      permanently.Immediate post-operative radiograph was then taken using preset exposure
      parameters.Follow up clinical and radiographic examination was carried out every 3 months,
      till a 12 month period. The data gathered was analyzed using suitable statistical methods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Radiographic success
time frame: every 3 months till 12 month period
description: Size of apical radiolucency were scored according to PAI scores and PAI score less than 3 were considered as success
measure: Clinical success
time frame: till 12 months
description: Presence or absence of any clinical symptoms such as pain,tenderness, sinus tract and swelling
measure: Pain intensity
time frame: Patients were asked to make a mark on the line that represented their level of perceived pain every 24hrs for7 days following intervention
description: Pain intensity before and after treatment. Intensity of pain was recorded using 10 cm VAS scale with 0 depicting no pain and 10 depicting maximum pain imaginable.
arm group label: Smear Layer Positive
arm group type: Experimental
description: Root canal treatment without smear layer removal: Root canal treatment and Irrigation with 1 ml of 2.5% sodium' hypochlorite for 1 min, followed by ultrasonic activation of 3 ml of 2.5% sodium hypochlorite for 1minute.
arm group label: Smear layer negative
arm group type: Active Comparator
description: root canal treatment with smear layer removal:Root canal treatment and Irrigation with 1 mL of 17% EDTA solution and ultrasonic activation, followed by ultrasonic activation of 3 ml of 2.5% sodium hypochlorite for 1 minute.
intervention type: Procedure
intervention name: Root canal treatment with smear layer removal
description: Canal were irrigated with Naocl and EDTA to remove smear layer
arm group label: Smear layer negative
other name: irrigation with EDTA
intervention type: Procedure
intervention name: Root canal treatment without smear layer removal
description: only sodium hypochlorite was used for irrigation
arm group label: Smear Layer Positive
other name: irrigation with only NAOCL
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Periodontitis
mesh term: Periapical Periodontitis
mesh term: Smear Layer
sharing ipd: No