<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/NCT03288467</url>
  </required_header>
  <id_info>
    <org_study_id>Neha Verma</org_study_id>
    <nct_id>NCT03288467</nct_id>
  </id_info>
  <brief_title>Effect of Sodium Hypochlorite Concentration on Success of Non-surgical Root Canal Treatment</brief_title>
  <official_title>Effect of Sodium Hypochlorite Concentration on Success of Non-surgical Root Canal Treatment: 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>
      .There is no general agreement regarding the optimal concentration of sodium hypochlorite to&#xD;
      be used in endodontic treatment.Therefore, this study aims to evaluate the effect of sodium&#xD;
      hypochlorite concentration on the success of primary root canal treatment. The study&#xD;
      population comprised of patients requiring primary root canal treatment following the&#xD;
      diagnosis of pulpal necrosis with chronic apical periodontitis in mature mandibular first and&#xD;
      second molars.Patients were randomly allocated in either High concentration or Low&#xD;
      concentration group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AIMS AND OBJECTIVES&#xD;
&#xD;
        1. To evaluate the success of primary endodontic treatment following use of 5% and 1% NaOCl&#xD;
           in non-vital, posterior teeth.&#xD;
&#xD;
        2. To compare the success achieved following use of the two different concentrations of&#xD;
           NaOCl.&#xD;
&#xD;
        3. To evaluate postoperative pain following use of 5% and 1% NaOCl.&#xD;
&#xD;
      MATERIALS AND METHODS: Mature mandibular first and second molars with diagnosis of pulp&#xD;
      necrosis (as confirmed by negative response to cold and electric pulp testing), and having&#xD;
      apical radiolucency were chosen for the study.The consenting subjects were allocated to one&#xD;
      of the two study groups based on concentration of NaOCl used: 5% [high concentration (HC)]&#xD;
      and 1% [low concentration (LC)].Using an equal proportion randomization allocation ratio,&#xD;
      envelopes containing concealed assignment codes were assigned sequentially to eligible&#xD;
      patients.It was ensured that neither the patient, nor the primary investigator was aware of&#xD;
      the treatment protocol before beginning of the treatment procedure.&#xD;
&#xD;
      CLINICAL PROCEDURE:&#xD;
&#xD;
      2% lidocaine with 1/80000 epinephrine was used to achieve profound local anaesthesia.&#xD;
&#xD;
      After proper isolation with rubber dam, access cavity was made with a high speed handpiece&#xD;
      and carbide bur.&#xD;
&#xD;
      Debridement of the pulp chamber was done and all canal orifices were identified Lubricant (RC&#xD;
      Prep) was placed at the entrance of the canal and canals negotiated with 10 no. K file.&#xD;
&#xD;
      Working length was established 1mm short of apical foramen by electronic apex loactor (Root&#xD;
      ZX) and confirmed radiographically.&#xD;
&#xD;
      Root canal preparation was done by using rotary files according to manufacturer's&#xD;
      instructions.&#xD;
&#xD;
      In both groups, 5ml of sodium hypochlorite was used as irrigant after each instrument change.&#xD;
      All the irrigation procedures was performed using a 30 gauge needle. 5% and 1% NaOCl was used&#xD;
      in HC and LC, respectively.&#xD;
&#xD;
      After root canal instrumentation, canals was irrigated with 5ml of 17% EDTA solution for 1&#xD;
      minute followed by final wash with 5ml of 5% or 1% sodium hypochlorite, depending on the&#xD;
      group.&#xD;
&#xD;
      Canals were dried with sterile absorbent paper points and filled with calcium hydroxide paste&#xD;
      and the access cavity restored with Cavit.&#xD;
&#xD;
      The patients were recalled after 1 week. At the next appointment, the paste was removed with&#xD;
      the use of Hedstroem files and copious irrigation with 5% or 1% sodium hypochlorite followed&#xD;
      by 5ml 17% EDTA and a final rinse with 5ml 5% or 1% sodium hypochlorite.&#xD;
&#xD;
      Then, canals were obturated with the Gutta percha by lateral condensation technique and Zinc&#xD;
      Oxide- Eugenol based sealer in both the groups.&#xD;
&#xD;
      After obturation, the cavity was restored permanently. Immediate post-operative radiograph&#xD;
      was then be taken.&#xD;
&#xD;
      All the patients were prescribed Ibuprofen 400mg with the instructions to take only one&#xD;
      tablet every 8 hours in the event of pain, if needed.Patients were asked to record the&#xD;
      severity of pain using 10 cm VAS scale with 0 depicting no pain and 10 depicting maximum pain&#xD;
      imaginable. Patients were asked to make a mark on the line that represented their level of&#xD;
      perceived pain at 6 hr ,12 hr ,1 day,2 days,3 days,4 days,5 days,6 days and 7 days.One week&#xD;
      later, patients returned with the completed questionnaires.&#xD;
&#xD;
      Follow up clinical and radiographic examination carried out every 3 months, till 12 month&#xD;
      period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2016</start_date>
  <completion_date type="Actual">November 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</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 months</time_frame>
    <description>Treatment outcome was judged on the basis of radiographic findings recorded at the follow up visit and comparison of the radiographs obtained at post obturation and the follow-up visit.Change in Periapical Index (PAI) scores observed at 12-months was noted and scoring of each tooth was done according to the PAI scores and 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>Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility, and no deterioration in periodontal probing depth as compared with baseline measurements comprised the criteria for clinical success.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>Pain intensity recorded at different intervals (preoperatively, after 6 hours, 12 hours, 1day, 2 days, 3 days, 4days, 5 days, 6 days and 7 days).</time_frame>
    <description>Pain intensity before and after treatmemt was recorded by use of 10cm VAS with zero depicting no pain and 10 depicting maximum pain.Patient rate their pain intensity by making a mark somewhere on the line that represents their pain intensity and VAS was scored by measuring the distance from the &quot;no pain&quot; end of line.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Apical Periodontitis</condition>
  <arm_group>
    <arm_group_label>Root canal treatment with 5% NaOCl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Root canal treatment with 5% NaOCl: 5 ml of 5% sodium hypochlorite was used during root canal treatment after each instrument change.After root canal instrumentation, canals irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 5% sodium hypochlorite.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Root canal treatment with 1% NaOCl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 ml of 1% soium hypochlorite was used during root canal treatment after each instrument change.After root canal instrumentation, canals irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 1% sodium hypochlorite.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Root canal treatment with 5% NaOCl</intervention_name>
    <arm_group_label>Root canal treatment with 5% NaOCl</arm_group_label>
    <other_name>Endodontic treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Root canal treatment with 1% NaOCl</intervention_name>
    <arm_group_label>Root canal treatment with 1% NaOCl</arm_group_label>
    <other_name>Endodontic treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient willingness to participate in the study&#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;
          -  Positive history of antibiotic use within past one month of the treatment.&#xD;
&#xD;
          -  Positive history of analgesic use within the past 3 days.&#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>47 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>May 22, 2018</last_update_submitted>
  <last_update_submitted_qc>May 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Periapical Periodontitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03288467
org study id: Neha Verma
nct id: NCT03288467
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
.There is no general agreement regarding the optimal concentration of sodium hypochlorite to
      be used in endodontic treatment.Therefore, this study aims to evaluate the effect of sodium
      hypochlorite concentration on the success of primary root canal treatment. 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.Patients were randomly allocated in either High concentration or Low
      concentration group.
AIMS AND OBJECTIVES

        1. To evaluate the success of primary endodontic treatment following use of 5% and 1% NaOCl
           in non-vital, posterior teeth.

        2. To compare the success achieved following use of the two different concentrations of
           NaOCl.

        3. To evaluate postoperative pain following use of 5% and 1% NaOCl.

      MATERIALS AND METHODS: Mature mandibular first and second molars with diagnosis of pulp
      necrosis (as confirmed by negative response to cold and electric pulp testing), and having
      apical radiolucency were chosen for the study.The consenting subjects were allocated to one
      of the two study groups based on concentration of NaOCl used: 5% [high concentration (HC)]
      and 1% [low concentration (LC)].Using an equal proportion randomization allocation ratio,
      envelopes containing concealed assignment codes were assigned sequentially to eligible
      patients.It was ensured that neither the patient, nor the primary investigator was aware of
      the treatment protocol before beginning of the treatment procedure.

      CLINICAL PROCEDURE:

      2% lidocaine with 1/80000 epinephrine was used to achieve profound local anaesthesia.

      After proper isolation with rubber dam, access cavity was made with a high speed handpiece
      and carbide bur.

      Debridement of the pulp chamber was done and all canal orifices were identified Lubricant (RC
      Prep) was placed at the entrance of the canal and canals negotiated with 10 no. K file.

      Working length was established 1mm short of apical foramen by electronic apex loactor (Root
      ZX) and confirmed radiographically.

      Root canal preparation was done by using rotary files according to manufacturer's
      instructions.

      In both groups, 5ml of sodium hypochlorite was used as irrigant after each instrument change.
      All the irrigation procedures was performed using a 30 gauge needle. 5% and 1% NaOCl was used
      in HC and LC, respectively.

      After root canal instrumentation, canals was irrigated with 5ml of 17% EDTA solution for 1
      minute followed by final wash with 5ml of 5% or 1% sodium hypochlorite, depending on the
      group.

      Canals were dried with sterile absorbent paper points and filled with calcium hydroxide paste
      and the access cavity restored with Cavit.

      The patients were recalled after 1 week. At the next appointment, the paste was removed with
      the use of Hedstroem files and copious irrigation with 5% or 1% sodium hypochlorite followed
      by 5ml 17% EDTA and a final rinse with 5ml 5% or 1% sodium hypochlorite.

      Then, canals were obturated with the Gutta percha by lateral condensation technique and Zinc
      Oxide- Eugenol based sealer in both the groups.

      After obturation, the cavity was restored permanently. Immediate post-operative radiograph
      was then be taken.

      All the patients were prescribed Ibuprofen 400mg with the instructions to take only one
      tablet every 8 hours in the event of pain, if needed.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 at 6 hr ,12 hr ,1 day,2 days,3 days,4 days,5 days,6 days and 7 days.One week
      later, patients returned with the completed questionnaires.

      Follow up clinical and radiographic examination carried out every 3 months, till 12 month
      period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Radiographic success
time frame: Every 3 months till 12 months
description: Treatment outcome was judged on the basis of radiographic findings recorded at the follow up visit and comparison of the radiographs obtained at post obturation and the follow-up visit.Change in Periapical Index (PAI) scores observed at 12-months was noted and scoring of each tooth was done according to the PAI scores and score less than 3 were considered as success.
measure: Clinical success
time frame: Till 12 months
description: Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility, and no deterioration in periodontal probing depth as compared with baseline measurements comprised the criteria for clinical success.
measure: Pain intensity
time frame: Pain intensity recorded at different intervals (preoperatively, after 6 hours, 12 hours, 1day, 2 days, 3 days, 4days, 5 days, 6 days and 7 days).
description: Pain intensity before and after treatmemt was recorded by use of 10cm VAS with zero depicting no pain and 10 depicting maximum pain.Patient rate their pain intensity by making a mark somewhere on the line that represents their pain intensity and VAS was scored by measuring the distance from the "no pain" end of line.
arm group label: Root canal treatment with 5% NaOCl
arm group type: Active Comparator
description: Root canal treatment with 5% NaOCl: 5 ml of 5% sodium hypochlorite was used during root canal treatment after each instrument change.After root canal instrumentation, canals irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 5% sodium hypochlorite.
arm group label: Root canal treatment with 1% NaOCl
arm group type: Active Comparator
description: 5 ml of 1% soium hypochlorite was used during root canal treatment after each instrument change.After root canal instrumentation, canals irrigated with 5ml of 17% EDTA solution for 1 minute followed by final wash with 5ml of 1% sodium hypochlorite.
intervention type: Procedure
intervention name: Root canal treatment with 5% NaOCl
arm group label: Root canal treatment with 5% NaOCl
other name: Endodontic treatment
intervention type: Procedure
intervention name: Root canal treatment with 1% NaOCl
arm group label: Root canal treatment with 1% NaOCl
other name: Endodontic treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 47 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Periodontitis
mesh term: Periapical Periodontitis