xml: <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/NCT05985759</url>
    </required_header>
    <id_info>
      <org_study_id>ECR1652InstKA2022/230506010</org_study_id>
      <nct_id>NCT05985759</nct_id>
    </id_info>
    <brief_title>Comparative Evaluation of the Effect of 970 nm Diode Laser With or Without N Acetyl Cysteine on Post Operative Pain After Endodontic Treatment in Teeth With Symptomatic Apical Periodontiti</brief_title>
    <official_title>Comparative Evaluation of the Effect of 970 nm Diode Laser With or Without N Acetyl Cysteine on Post Operative Pain After Endodontic Treatment in Teeth With Symptomatic Apical Periodontitis: a Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bapuji Dental College &amp; Hospital Davengere Karnataka</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bapuji Dental College &amp; Hospital Davengere Karnataka</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        One of the most important aspect of endodontic treatment is management of postoperative pain&#xD;
        management . Post operative pain after endodontic treatment is a frequent complication.&#xD;
        frequency of post operative pain is between 3% to 58% .&#xD;
  &#xD;
        Post operative pain could also occur as a result of inadequate instrumentation, extrusion of&#xD;
        irrigation solutions, extrusion of intra-canal dressing, traumatic occlusion, missed canals,&#xD;
        preoperative pain, periapical pathosis and extrusion of apical debris. Furthermore,&#xD;
        instrument choice might also play an important role. The apical extrusion of infected debris&#xD;
        during chemo-mechanical instrumentation of root canals might exacerbate the inflammatory&#xD;
        response and cause peri-radicular inflammation.&#xD;
  &#xD;
        The use of diode lasers, in addition to conventional endodontic therapy, has recently been&#xD;
        proposed in RCT Various researchers have observed effective disinfection of the root canal by&#xD;
        diode laser irradiation Due to the large water transmission capacities of diode lasers (810,&#xD;
        940 and 980-nm wavelengths), they can reach bacteria in deeper layers of dentinal tubules(3)&#xD;
        Schoop et al. reported that using a 980-nm diode laser resulted in changes in dentinal&#xD;
        surfaces and an increased bactericidal effect.&#xD;
  &#xD;
        Other studies noted that laser irradiation decreases PP after RCT Over the years, studies&#xD;
        have focused on identifying molecular mediators of inflammation induction, such as cytokines&#xD;
        and chemokines in apical periodontitis. It was widely accepted that the loss of&#xD;
        pro-inflammatory mediators was the 'turn off' signal of inflammation, ending subsequent&#xD;
        responses passively.&#xD;
  &#xD;
        Karapinar et al N-acetylcysteine (NAC) has been proposed as a potential alternative&#xD;
        therapeutic agent in root canal treatment. NAC is an antioxidant mucolytic agent derivative&#xD;
        of the amino acid L cysteine. As the precursor of glutathione, NAC can incorporate into cells&#xD;
        and neutralize oxygen-derived free radicals (ROS), diminishing the cumulative effects of&#xD;
        oxidative stress Previous studies have demonstrated the antimicrobial properties of NAC&#xD;
        against several biofilm phenotypes, including oral pathogens such as Enterococcus faecalis,&#xD;
        which is often found in endodontic infections. Moreover, NAC has been reported to exert&#xD;
        anti-inflammatory activity by inhibiting the expression of lipopolysaccharide-induced&#xD;
        inflammatory mediators.&#xD;
  &#xD;
        Another study showed that the antibacterial effect of NAC is higher than that of NaOCl and&#xD;
        CHX. More specifically, 200 mg/ ml solution of NAC was found to be more efficient than 5.25%&#xD;
        NaOCl and 2% CHX in killing E. faecalis and S. mutant bacteria.(5) NAC exerts&#xD;
        anti-inflammatory activity through its ability to inhibit the expression and release of a&#xD;
        variety of proinflammatory cytokines. NAC can be a substitute for ibuprofen for&#xD;
        post-endodontic pain. All these findings provide support for a superior potential for NAC in&#xD;
        endodontic treatment.(6) Due to the scarcity of information on the effect of NAC as an&#xD;
        intracanal medication, and the lack of systematic review on the same, this study aimed to&#xD;
        compare and evaluate the post-operative pain when 970nm diode laser used with or without N&#xD;
        acetyl cysteine as intracanal medicament&#xD;
  &#xD;
        RESEARCH QUESTION : Will there be a difference in the postoperative pain after Endodontic&#xD;
        treatment of mandibular molars with symptomatic apical periodontitis using 970nm diode laser&#xD;
        with or without N acetyl cysteine ?&#xD;
  &#xD;
        RESEARCH HYPOTHESIS (H1): There will be a difference in the postoperative pain after&#xD;
        Endodontic treatment of mandibular molars with symptomatic apical periodontitis using 970nm&#xD;
        diode laser with or without N acetyl cysteine&#xD;
  &#xD;
        NULL HYPOTHESIS (H0): There will be no difference in the postoperative pain after Endodontic&#xD;
        treatment of mandibular molars with symptomatic apical periodontitis using 970nm diode laser&#xD;
        with or without N acetyl cysteine&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. To assess the postoperative pain after Endodontic treatment of mandibular molars with&#xD;
             symptomatic apical periodontitis using N acetyl cysteine as intracanal medicament&#xD;
  &#xD;
          2. To assess the postoperative pain after Endodontic treatment of mandibular molars with&#xD;
             symptomatic apical periodontitis using 970nm diode laser .&#xD;
  &#xD;
          3. To assess the postoperative pain after Endodontic treatment of mandibular molars with&#xD;
             symptomatic apical periodontitis using 970nm diode laser with N acetyl cysteine .&#xD;
  &#xD;
          4. To compare the incidence of postoperative pain after endodontic treatment of mandibular&#xD;
             molar with symptomatic apical periodontitis using N acetyl cysteine , 970nm diode laser&#xD;
             , 970nm diode laser and N acetyl cysteine as intracanal medicament&#xD;
  &#xD;
        7. MATERIALS AND METHODS: 7.1 TYPE OF STUDY: An in vivo study 7.2 SOURCE: The study will be&#xD;
        performed on mandibular molar. Study is to be conducted in Dept. of Conservative Dentistry&#xD;
        and Endodontics, BDCH, Davangere&#xD;
  &#xD;
        7.3 Materials and Equipment&#xD;
  &#xD;
          -  4 round bur ( Mani ,Japan ) Endo Z bur (Dentsply Sirona , India)&#xD;
  &#xD;
          -  10, #15 K files of 21mm length (MANI) Protaper gold (DENTSPLY SIRONA) of 21mm length&#xD;
             Disposable syringes (BD Glide) Side vented needle (neoendo) Beakers 0.9% Normal saline&#xD;
             (INFUTEC NS) Airotor handpiece (Rotomax) Canalpro cl2i endomotor (Coltene ,India) Apex&#xD;
             locater (j morita root zx) 17% EDTA solution (DENTAL AVENUE) 2.5% NaOCl solution (SDFCL)&#xD;
             N acetyl cysteine (Sigma Aldrich , Merck KGaA, Darmstadt, Germany) Sirolaser blue&#xD;
             (Sirolaser blue , Dentsply Maillefer, Ballaigues, Switzerland) Cavit (Cavit-G; 3 M ESPE,&#xD;
             St Paul, MN) EQUIPMENT&#xD;
  &#xD;
               -  X ray PSP scanner (PSP -SOREDEX DIGORA Optime) 7.2 Method of collection of data&#xD;
                  (including sampling procedure, if any): Simple random&#xD;
  &#xD;
        METHODOLOGY Mandibular block anesthesia performed using local anesthetics solution 1.8ml 2%&#xD;
        lidocaine with 1:80000 epinephrine. The procedure started after lip numbness was achieved.&#xD;
        Occlusal reduction will be done followed by straight-line access cavity and the procedure was&#xD;
        completed under rubber dam isolation. The working length was determined using an electronic&#xD;
        apex locator (J morita), and Endomotor (Canalpro cl2i ,Coltene ,India) , Protaper gold&#xD;
        (Dentsply Maillefer, Ballaigues, Switzerland) was used according to the manufacturer's&#xD;
        instructions for cleaning and shaping .&#xD;
  &#xD;
        A size 10 K-file was used to maintain apical patency, 2 mL 2.5% sodium hypochlorite was used&#xD;
        between in-and-out pecking motions, and After instrumentation, The needle was advanced to a&#xD;
        depth of 2-3 mm short of WL and the canal will be irrigated with 3 mL of 2.5% NaOCl. Final&#xD;
        irrigation will be done with 5 mL of 17% EDTA for 1 min followed by a final rinse with 5ml of&#xD;
        saline.&#xD;
  &#xD;
        Randomization After that, patients were randomly assigned to one of the three groups based on&#xD;
        the post operative therapy&#xD;
  &#xD;
        ROOT CANAL INSTRUMENTATION&#xD;
  &#xD;
        The patients will be randomly divided into 3 groups containing teeth in each group namely:&#xD;
  &#xD;
        GROUP I(n=20): N acetyl cysteine GROUP II(n=20) : 970 nm diode laser Group II(n=20): 970 nm&#xD;
        diode laser + N acetyl cysteine&#xD;
  &#xD;
        Group I :&#xD;
  &#xD;
        After the canals are dried with paper point N acetyl cysteine paste was applied as&#xD;
        intra-canal medicament , and the access cavity was sealed using a temporary restorative&#xD;
        material&#xD;
  &#xD;
        GROUP II:&#xD;
  &#xD;
        The final irrigation was performed , after the canals were dried with paper-points. During&#xD;
        the laser treatment, both the operator and patient wore protective eyewear. Laser irradiation&#xD;
        was applied using a 970-nm diode laser (Sirolaser blue , Dentsply Maillefer, Ballaigues,&#xD;
        Switzerland) coupled with a 200-μm optical fibre. The settings were as follows: output power&#xD;
        of 1.5 W in the pulsed mode irradiation for 10 s, followed by a 10-s pause, which comprised&#xD;
        one cycle. This cycle was applied four times to each root canal. The power used was 1.5 W&#xD;
        with a low frequency of 15 Hz. The optical fibre tip (length of 25 mm) was inserted at the&#xD;
        working length. The root canals were then slowly (at a speed of 2 mm/s) irradiated from the&#xD;
        apical to coronal using a continuous circling movement touching the dentinal walls in one&#xD;
        cycle for each power. and the access cavity was sealed using a temporary restorative&#xD;
        material.&#xD;
  &#xD;
        GROUP III:&#xD;
  &#xD;
        The final irrigation was performed as in the control group, and the canals were dried with&#xD;
        paper points. During the laser treatment, both the operator and patient wore protective&#xD;
        eyewear. Laser irradiation was applied using a 970-nm diode laser (sirolaser blue Dentsply&#xD;
        Maillefer, Ballaigues, Switzerland ) coupled with a 200-μm optical fibre .The settings were&#xD;
        as follows: power of 1.5 W and in the pulsed mode , irradiation for 10 s, followed by a 10-s&#xD;
        pause, which comprised one cycle. This cycle was applied four times to each root canal. The&#xD;
        power used was 1.5 W with a low frequency of 15 Hz. The optical fibre tip (length of 25 mm)&#xD;
        was inserted at the working length. The root canals were then slowly (at a speed of 2 mm/s)&#xD;
        irradiated from the apical to coronal using a continuous circling movement touching the&#xD;
        dentinal walls in one cycle for each power.&#xD;
  &#xD;
        Following the irradiation procedure, N acetyl cysteine paste was applied as intra-canal&#xD;
        medicament , and the access cavity was sealed using a temporary restorative material, as in&#xD;
        the control group&#xD;
  &#xD;
        Subsequently, a temporary restorative material (Cavit-G; 3 M ESPE, St Paul, MN) was used to&#xD;
        seal the access cavity.&#xD;
  &#xD;
        At the time of the first visit, all the patients were given a VAS to rate their PP. A second&#xD;
        appointment was scheduled for 7 d later. All patients who met the final inclusion criteria&#xD;
        were given a pain chart to be completed to record the incidence of pain (yes/no), level of&#xD;
        posttreatment pain and duration of pain (days).&#xD;
  &#xD;
        The following variables were recorded:&#xD;
  &#xD;
          1. Age&#xD;
  &#xD;
          2. Sex&#xD;
  &#xD;
          3. Tooth number&#xD;
  &#xD;
          4. Number of canals&#xD;
  &#xD;
        6. Preoperative pain on the VAS 7. Preoperative and postoperative percussion pain levels (on&#xD;
        the 7th day) on the VAS 8. Pain level on the 8 hr ,24 hr, 48hr , 72hr &amp; 7 day 11. Analgesic&#xD;
        intake after the procedure&#xD;
  &#xD;
        At the second appointment, the ICM was removed from the root canals with final irrigation and&#xD;
        using an F3/F2 file. The root canals were then obturated using the cold lateral condensation&#xD;
        method with gutta-percha cones and AH Plus sealer (Dentsply Maillefer, Ballaigues,&#xD;
        Switzerland). The coronal restoration was finished using a resin composite (Filtek Z250, 3 M&#xD;
        ESPE, St. Paul, MN).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>Phase 4</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>modified visual analog scale</measure>
      <time_frame>7 days</time_frame>
      <description>evaluation of post endodontic pain</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Evaluation of Post Endodontic Pain</condition>
    <arm_group>
      <arm_group_label>970nm diode laser</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>N acetyle cystiene</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>calcium hydroxide</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>N acetyle cystiene</intervention_name>
      <description>N acetyle cystien is administerd due to its antibacterial action and anti inflamatory action</description>
      <arm_group_label>N acetyle cystiene</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:• Patients with mandibular molar with symptomatic apical periodontitis&#xD;
  &#xD;
            -  Periapical index up to 3 or 4.(8)&#xD;
  &#xD;
            -  Patient older than 18 to 60 years&#xD;
  &#xD;
            -  Spontaneous pain &lt;3mm&#xD;
  &#xD;
            -  Percussion pain &lt;3mm&#xD;
  &#xD;
            -  healthy induvidual&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Periodontal probing greater than 3mm&#xD;
  &#xD;
                 -  Previous root canal treatment&#xD;
  &#xD;
                 -  Swelling / sinus tract&#xD;
  &#xD;
                 -  Sever periodontal disease&#xD;
  &#xD;
                 -  Antibiotic use within last 5 days&#xD;
  &#xD;
                 -  Systemic disorders&#xD;
  &#xD;
                 -  Pregnancy and lactation&#xD;
  &#xD;
                 -  Traumatic occlusion&#xD;
  &#xD;
                 -  Severe crown destruction preventing rubber dam isolation&#xD;
  &#xD;
                 -  Presence of other teeth requiring RCT&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Rashmi N C, MDS</last_name>
      <phone>7347228077</phone>
      <email>ncrashmi@yahoo.in</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bapuji Dental College and Hospital , Davangere</name>
        <address>
          <city>Davangere</city>
          <state>Karnataka</state>
          <zip>577004</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>principal, bapuji dental college, MDS</last_name>
        <phone>91-220579, 220580</phone>
        <email>bapujidental@gmail.com</email>
      </contact>
      <investigator>
        <last_name>JOE PAUL UMBAVU, BDS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bapuji Dental College &amp; Hospital Davengere Karnataka</investigator_affiliation>
      <investigator_full_name>JOE PAUL UMBAVU</investigator_full_name>
      <investigator_title>post graduate student</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985759
  org study id: ECR1652InstKA2022/230506010
  nct id: NCT05985759
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  One of the most important aspect of endodontic treatment is management of postoperative pain
        management . Post operative pain after endodontic treatment is a frequent complication.
        frequency of post operative pain is between 3% to 58% .
  
        Post operative pain could also occur as a result of inadequate instrumentation, extrusion of
        irrigation solutions, extrusion of intra-canal dressing, traumatic occlusion, missed canals,
        preoperative pain, periapical pathosis and extrusion of apical debris. Furthermore,
        instrument choice might also play an important role. The apical extrusion of infected debris
        during chemo-mechanical instrumentation of root canals might exacerbate the inflammatory
        response and cause peri-radicular inflammation.
  
        The use of diode lasers, in addition to conventional endodontic therapy, has recently been
        proposed in RCT Various researchers have observed effective disinfection of the root canal by
        diode laser irradiation Due to the large water transmission capacities of diode lasers (810,
        940 and 980-nm wavelengths), they can reach bacteria in deeper layers of dentinal tubules(3)
        Schoop et al. reported that using a 980-nm diode laser resulted in changes in dentinal
        surfaces and an increased bactericidal effect.
  
        Other studies noted that laser irradiation decreases PP after RCT Over the years, studies
        have focused on identifying molecular mediators of inflammation induction, such as cytokines
        and chemokines in apical periodontitis. It was widely accepted that the loss of
        pro-inflammatory mediators was the 'turn off' signal of inflammation, ending subsequent
        responses passively.
  
        Karapinar et al N-acetylcysteine (NAC) has been proposed as a potential alternative
        therapeutic agent in root canal treatment. NAC is an antioxidant mucolytic agent derivative
        of the amino acid L cysteine. As the precursor of glutathione, NAC can incorporate into cells
        and neutralize oxygen-derived free radicals (ROS), diminishing the cumulative effects of
        oxidative stress Previous studies have demonstrated the antimicrobial properties of NAC
        against several biofilm phenotypes, including oral pathogens such as Enterococcus faecalis,
        which is often found in endodontic infections. Moreover, NAC has been reported to exert
        anti-inflammatory activity by inhibiting the expression of lipopolysaccharide-induced
        inflammatory mediators.
  
        Another study showed that the antibacterial effect of NAC is higher than that of NaOCl and
        CHX. More specifically, 200 mg/ ml solution of NAC was found to be more efficient than 5.25%
        NaOCl and 2% CHX in killing E. faecalis and S. mutant bacteria.(5) NAC exerts
        anti-inflammatory activity through its ability to inhibit the expression and release of a
        variety of proinflammatory cytokines. NAC can be a substitute for ibuprofen for
        post-endodontic pain. All these findings provide support for a superior potential for NAC in
        endodontic treatment.(6) Due to the scarcity of information on the effect of NAC as an
        intracanal medication, and the lack of systematic review on the same, this study aimed to
        compare and evaluate the post-operative pain when 970nm diode laser used with or without N
        acetyl cysteine as intracanal medicament
  
        RESEARCH QUESTION : Will there be a difference in the postoperative pain after Endodontic
        treatment of mandibular molars with symptomatic apical periodontitis using 970nm diode laser
        with or without N acetyl cysteine ?
  
        RESEARCH HYPOTHESIS (H1): There will be a difference in the postoperative pain after
        Endodontic treatment of mandibular molars with symptomatic apical periodontitis using 970nm
        diode laser with or without N acetyl cysteine
  
        NULL HYPOTHESIS (H0): There will be no difference in the postoperative pain after Endodontic
        treatment of mandibular molars with symptomatic apical periodontitis using 970nm diode laser
        with or without N acetyl cysteine
  1. To assess the postoperative pain after Endodontic treatment of mandibular molars with
             symptomatic apical periodontitis using N acetyl cysteine as intracanal medicament
  
          2. To assess the postoperative pain after Endodontic treatment of mandibular molars with
             symptomatic apical periodontitis using 970nm diode laser .
  
          3. To assess the postoperative pain after Endodontic treatment of mandibular molars with
             symptomatic apical periodontitis using 970nm diode laser with N acetyl cysteine .
  
          4. To compare the incidence of postoperative pain after endodontic treatment of mandibular
             molar with symptomatic apical periodontitis using N acetyl cysteine , 970nm diode laser
             , 970nm diode laser and N acetyl cysteine as intracanal medicament
  
        7. MATERIALS AND METHODS: 7.1 TYPE OF STUDY: An in vivo study 7.2 SOURCE: The study will be
        performed on mandibular molar. Study is to be conducted in Dept. of Conservative Dentistry
        and Endodontics, BDCH, Davangere
  
        7.3 Materials and Equipment
  
          -  4 round bur ( Mani ,Japan ) Endo Z bur (Dentsply Sirona , India)
  
          -  10, #15 K files of 21mm length (MANI) Protaper gold (DENTSPLY SIRONA) of 21mm length
             Disposable syringes (BD Glide) Side vented needle (neoendo) Beakers 0.9% Normal saline
             (INFUTEC NS) Airotor handpiece (Rotomax) Canalpro cl2i endomotor (Coltene ,India) Apex
             locater (j morita root zx) 17% EDTA solution (DENTAL AVENUE) 2.5% NaOCl solution (SDFCL)
             N acetyl cysteine (Sigma Aldrich , Merck KGaA, Darmstadt, Germany) Sirolaser blue
             (Sirolaser blue , Dentsply Maillefer, Ballaigues, Switzerland) Cavit (Cavit-G; 3 M ESPE,
             St Paul, MN) EQUIPMENT
  
               -  X ray PSP scanner (PSP -SOREDEX DIGORA Optime) 7.2 Method of collection of data
                  (including sampling procedure, if any): Simple random
  
        METHODOLOGY Mandibular block anesthesia performed using local anesthetics solution 1.8ml 2%
        lidocaine with 1:80000 epinephrine. The procedure started after lip numbness was achieved.
        Occlusal reduction will be done followed by straight-line access cavity and the procedure was
        completed under rubber dam isolation. The working length was determined using an electronic
        apex locator (J morita), and Endomotor (Canalpro cl2i ,Coltene ,India) , Protaper gold
        (Dentsply Maillefer, Ballaigues, Switzerland) was used according to the manufacturer's
        instructions for cleaning and shaping .
  
        A size 10 K-file was used to maintain apical patency, 2 mL 2.5% sodium hypochlorite was used
        between in-and-out pecking motions, and After instrumentation, The needle was advanced to a
        depth of 2-3 mm short of WL and the canal will be irrigated with 3 mL of 2.5% NaOCl. Final
        irrigation will be done with 5 mL of 17% EDTA for 1 min followed by a final rinse with 5ml of
        saline.
  
        Randomization After that, patients were randomly assigned to one of the three groups based on
        the post operative therapy
  
        ROOT CANAL INSTRUMENTATION
  
        The patients will be randomly divided into 3 groups containing teeth in each group namely:
  
        GROUP I(n=20): N acetyl cysteine GROUP II(n=20) : 970 nm diode laser Group II(n=20): 970 nm
        diode laser + N acetyl cysteine
  
        Group I :
  
        After the canals are dried with paper point N acetyl cysteine paste was applied as
        intra-canal medicament , and the access cavity was sealed using a temporary restorative
        material
  
        GROUP II:
  
        The final irrigation was performed , after the canals were dried with paper-points. During
        the laser treatment, both the operator and patient wore protective eyewear. Laser irradiation
        was applied using a 970-nm diode laser (Sirolaser blue , Dentsply Maillefer, Ballaigues,
        Switzerland) coupled with a 200-μm optical fibre. The settings were as follows: output power
        of 1.5 W in the pulsed mode irradiation for 10 s, followed by a 10-s pause, which comprised
        one cycle. This cycle was applied four times to each root canal. The power used was 1.5 W
        with a low frequency of 15 Hz. The optical fibre tip (length of 25 mm) was inserted at the
        working length. The root canals were then slowly (at a speed of 2 mm/s) irradiated from the
        apical to coronal using a continuous circling movement touching the dentinal walls in one
        cycle for each power. and the access cavity was sealed using a temporary restorative
        material.
  
        GROUP III:
  
        The final irrigation was performed as in the control group, and the canals were dried with
        paper points. During the laser treatment, both the operator and patient wore protective
        eyewear. Laser irradiation was applied using a 970-nm diode laser (sirolaser blue Dentsply
        Maillefer, Ballaigues, Switzerland ) coupled with a 200-μm optical fibre .The settings were
        as follows: power of 1.5 W and in the pulsed mode , irradiation for 10 s, followed by a 10-s
        pause, which comprised one cycle. This cycle was applied four times to each root canal. The
        power used was 1.5 W with a low frequency of 15 Hz. The optical fibre tip (length of 25 mm)
        was inserted at the working length. The root canals were then slowly (at a speed of 2 mm/s)
        irradiated from the apical to coronal using a continuous circling movement touching the
        dentinal walls in one cycle for each power.
  
        Following the irradiation procedure, N acetyl cysteine paste was applied as intra-canal
        medicament , and the access cavity was sealed using a temporary restorative material, as in
        the control group
  
        Subsequently, a temporary restorative material (Cavit-G; 3 M ESPE, St Paul, MN) was used to
        seal the access cavity.
  
        At the time of the first visit, all the patients were given a VAS to rate their PP. A second
        appointment was scheduled for 7 d later. All patients who met the final inclusion criteria
        were given a pain chart to be completed to record the incidence of pain (yes/no), level of
        posttreatment pain and duration of pain (days).
  
        The following variables were recorded:
  
          1. Age
  
          2. Sex
  
          3. Tooth number
  
          4. Number of canals
  
        6. Preoperative pain on the VAS 7. Preoperative and postoperative percussion pain levels (on
        the 7th day) on the VAS 8. Pain level on the 8 hr ,24 hr, 48hr , 72hr & 7 day 11. Analgesic
        intake after the procedure
  
        At the second appointment, the ICM was removed from the root canals with final irrigation and
        using an F3/F2 file. The root canals were then obturated using the cold lateral condensation
        method with gutta-percha cones and AH Plus sealer (Dentsply Maillefer, Ballaigues,
        Switzerland). The coronal restoration was finished using a resin composite (Filtek Z250, 3 M
        ESPE, St. Paul, MN).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: modified visual analog scale
  time frame: 7 days
  description: evaluation of post endodontic pain
  arm group label: 970nm diode laser
  arm group type: No Intervention
  arm group label: N acetyle cystiene
  arm group type: Experimental
  arm group label: calcium hydroxide
  arm group type: No Intervention
  intervention type: Drug
  intervention name: N acetyle cystiene
  description: N acetyle cystien is administerd due to its antibacterial action and anti inflamatory action
  arm group label: N acetyle cystiene
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rashmi N C, MDS
  phone: 7347228077
  email: ncrashmi@yahoo.in
  facility: 
  contact: 
  investigator: 
  country: India
  responsible party type: Principal Investigator
  investigator affiliation: Bapuji Dental College & Hospital Davengere Karnataka
  investigator full name: JOE PAUL UMBAVU
  investigator title: post graduate student
  mesh term: Pain, Postoperative
  sharing ipd: Undecided