<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/NCT03009006</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2016-10-147</org_study_id>
    <nct_id>NCT03009006</nct_id>
  </id_info>
  <brief_title>Post Operative Pain and Level of Endotoxins With Calcium Hydroxide and Calcium Hydroxide Mixed With Chlorhexidine in Treating Necrotic Teeth</brief_title>
  <official_title>Effect Of Combination of Calcium Hydroxide And Chlorhexidine Gel 2% as Intracanal Medication in Comparison to Calcium Hydroxide Paste as Intracanal Medication on Postoperative Pain And Bacterial Endotoxins in Necrotic Teeth:</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this prospective in vivo randomized clinical trial to evaluate influence of&#xD;
      combination of calcium Hydroxide (CALCIPAST Paste, Poland) and chlorhexidine Gel 2%&#xD;
      (Gluco-Chex 2%, Cerkamed, Poland) in comparison to calcium hydroxide paste (CALCIPAST Paste,&#xD;
      Poland) as Intracanal Medication on post operative pain (incidence, degree, duration) and&#xD;
      reduction of bacterial endotoxins (quantitative) after endodontic treatment in single rooted&#xD;
      necrotic teeth.&#xD;
&#xD;
      According to the inclusion criteria the patients enrolled in the study and allocated randomly&#xD;
      into three groups either combination of calcium hydroxide paste intracanal medication with 2%&#xD;
      chlorhexidine gel. (group A) or calcium hydroxide paste intracanal medication only (group B)&#xD;
      or mechanical preparation without intracanal medications (group C) the endodontic treatment&#xD;
      is done at two visits.&#xD;
&#xD;
      The samples of endotoxin divided into three groups: after access (S1), after mechanical&#xD;
      instrumentations (S2), after removal intracanal medication (S3), all samples taken by a&#xD;
      sterile paper points introduced in the root canal for the working length for 60 seconds.&#xD;
&#xD;
      firstly the patient's medical and dental history is taken. the patients assign on informed&#xD;
      consent. and then anaesthetized and access cavity performed and root canal preparation is&#xD;
      done by Revo-s system then irrigation and intracanal medication placement inside to canal.&#xD;
      the patient's record the post operative pain in sheet with NRS after 4, 24, 48 hours and 2&#xD;
      weeks after first visit. the operator will recall the patient to check the records&#xD;
&#xD;
      second visit After 2 weeks from application of ICM, rubber dam will be applied then removal&#xD;
      of the temporary dressing, then a sterile paper point (S3) will be introduced into the canals&#xD;
      after irrigation and removal of the remnants of the intracanal medicament with the saline&#xD;
      solution.&#xD;
&#xD;
        -  Removal of the paper sample to determine the endotoxin concentration.&#xD;
&#xD;
        -  The canals will be obturated by single cone technique using gutta percha point tapered&#xD;
           0.4% (Gutta percha point, Revo-S MicroMega CO., LTD, France) corresponding to the final&#xD;
           apical size of the file and the root canal sealer will be resin sealer (Adseal, META&#xD;
           BIOMED CO., LTD, Korea).&#xD;
&#xD;
        -  Pain will be assessed by numerical pain rating scale (NRS) after 14 days from the first&#xD;
           visit (at the day of the Obturation) before the beginning of Obturation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Medical and dental history: diagnostic charts will be collected in a case report from by the&#xD;
      investigators and confirmed for eligibility with the assistant supervisor.&#xD;
&#xD;
      Radiographic examination: preoperative radiographs will be taken to examine the tooth&#xD;
      structure, caries detection, periapical status.&#xD;
&#xD;
      Clinical examination: intraoral examination include visual examination for caries,&#xD;
      restorations, swelling, fistula, mobility, percussion were done.&#xD;
&#xD;
      Diagnostic criteria for necrotic tooth:&#xD;
&#xD;
        1. The patient marks moderate to severe pain on the numerical rating scale (NRS)a&#xD;
           horizontal line of 11 marks and 10 intervals each takes number form 0 - 10 0 reading&#xD;
           represents &quot;no pain&quot;, 1- 3 readings represent &quot;mild pain&quot;, 4- 6 readings represent&#xD;
           &quot;moderate pain&quot;, 7- 10 readings represent &quot;severe pain&quot;.&#xD;
&#xD;
           (recording baseline degree of pain preoperatively before initiating the endodontic&#xD;
           treatment ) All step will done by operator.&#xD;
&#xD;
           The measurement time will be at 4 hours, 24 hours, and 48 hours and after 14 days. (Day&#xD;
           of Obturation)&#xD;
&#xD;
        2. The patient not responding to electric pulp tester at higher level than the&#xD;
           contralateral tooth or the adjacent tooth if the contralateral one is missing.&#xD;
&#xD;
        3. Preoperative periapical x- ray film is done to detect any periapical changes.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      Forty five patients will include were allocated by random or by chance to receive several&#xD;
      clinical interventions and one of these interventions was control (Group A) where the&#xD;
      patients did not receive any intracanal medication, (Group B) where the patients receive&#xD;
      intracanal medication calcium hydroxide (CALCIPAST Paste, (Poland) and chlorhexidine 2 % gel.&#xD;
      (Gluco-Chex 2%, Cerkamed, Poland), (Group C) calcium hydroxide paste only CALCIPAST Paste&#xD;
      (Poland).&#xD;
&#xD;
      Procedure steps:&#xD;
&#xD;
      At the 1st appointment.&#xD;
&#xD;
        -  Each patient will be given a numerical pain rating scale chart in order to rate his /her&#xD;
           presenting pain as preoperative pain&#xD;
&#xD;
        -  Anesthesia will be done with Carpule 3M™ ESPE™ Ubistesin™ Articaine HCI 4% &amp; Adrenaline&#xD;
           1:100,000 3M Australia the tooth with decayed using a standard dental aspirating&#xD;
           syringe.&#xD;
&#xD;
        -  After diagnosis disinfecting the tooth surface by 30% H2O2 (Perfect Medical, Egypt)&#xD;
           followed by 2.5% NaOCl inactivated with sodium thiosulfate (El Nasr CO. for&#xD;
           pharmaceuticals and chemicals).&#xD;
&#xD;
        -  Access cavity will do under rubber dam isolation and with Sterile burs for access cavity&#xD;
           preparation with distilled water as a coolant and flaring will done by endo-z bur.&#xD;
&#xD;
        -  If successful anesthesia occurs, working length will be determined with an apex locator&#xD;
           (Root ZX, J.Morita, Irvine, California, USA.) then confirmed with intraoral periapical&#xD;
           radiograph (Kodac Dental film, speed D, size 2, Carestream Health, Rochester, NY, USA)&#xD;
           to confirm the length to be 0.5-1 mm shorter than radiographic apex.&#xD;
&#xD;
        -  The first sample of endotoxin (S1) is taken by a sterile paper points after access&#xD;
           cavity preparation and introduced in the root canal for the working length for 60&#xD;
           seconds.&#xD;
&#xD;
        -  The sample is then placed in a pyrogenic free plastic tube and frozen to negative 200c&#xD;
           for endotoxin determination by LAL test.&#xD;
&#xD;
        -  Canal instrumentation will be done using NiTi rotary files system (Revo-S MicroMega,&#xD;
           France) in an endodontic motor (X-Smart, Dentsply Maillefer, USA.) according to the&#xD;
           manufacturer instructions to ensure adequate space for placement of the intracanal&#xD;
           medicaments and proper removal of bacteria and debris, till size AS 35 file. The rotary&#xD;
           files will be introduced inside the canal with EDTA gel (MD-Chelcream, META BIOMED CO.,&#xD;
           LTD, Korea) as lubricant.&#xD;
&#xD;
        -  The irrigant solution will be NaOCl with concentration 2.5% for its tissue dissolving&#xD;
           properties between each file and will be delivered by disposable plastic syringe.&#xD;
&#xD;
        -  Another sample (S2) will be taken after the cleaning and shaping and before placing the&#xD;
           intracanal medications by sterile paper point for endotoxin determination.&#xD;
&#xD;
        -  The first group will be subjected to combined therapy of both calcium hydroxide&#xD;
           intracanal medication CALCIPAST Paste (Poland), with 2% chlorhexidine gel intracanal&#xD;
           medication (Gluco-Chex 2%, Cerkamed, Poland) after the cleaning and shaping for 2 weeks&#xD;
           period.&#xD;
&#xD;
        -  The second group will be subjected to calcium hydroxide intracanal medication alone for&#xD;
           2 weeks period after the cleaning and shaping. Calcium hydroxide will be in form of&#xD;
           ready-made paste in a measured special syringe CALCIPAST (Poland).&#xD;
&#xD;
        -  The third group will receive plain cotton with temporary filling without any intracanal&#xD;
           medication.&#xD;
&#xD;
        -  Placement of the intracanal medications by lentuolo spiral by low speed hand piece and&#xD;
           condensed with paper points.&#xD;
&#xD;
        -  Temporary filling is done by glass ionmer filling to ensure proper sealing with no&#xD;
           leakage of any oral fluids inside the root canal, which may disturb the action of the&#xD;
           intracanal medication.&#xD;
&#xD;
        -  Pain will be assessed by numerical pain rating scale (NRS) will be given to each patient&#xD;
           to complete a t home at the specified times at 4, 24, 48 hours after the first visit.&#xD;
&#xD;
      At the 2nd appointment:&#xD;
&#xD;
        -  After 2 weeks from application of ICM, rubber dam will be applied then removal of the&#xD;
           temporary dressing by following the previous infection control protocol, then a sterile&#xD;
           paper point (S3) will be introduced into the canals after irrigation and removal of the&#xD;
           remnants of the intracanal medicament with the saline solution.&#xD;
&#xD;
        -  Removal of the paper sample to determine the endotoxin concentration.&#xD;
&#xD;
        -  The canals will be obturated by single cone technique using gutta percha point tapered&#xD;
           0.4% (Gutta percha point, Revo-S MicroMega CO., LTD, France) corresponding to the final&#xD;
           apical size of the file and the root canal sealer will be resin sealer (Adseal, META&#xD;
           BIOMED CO., LTD, Korea).&#xD;
&#xD;
        -  Pain will be assessed by numerical pain rating scale (NRS) after 14 days from the first&#xD;
           visit (at the day of the Obturation) before the beginning of Obturation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 3, 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">October 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>4, 24, 48 hrs and 2 weeks after completion of treatment</time_frame>
    <description>intensity of postoperative pain between visits by numerical Rating Scale (0- 10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>bacterial endotoxins reductions</measure>
    <time_frame>After access cavity, after mechanical preparation and after removal of intracanal medication (2 weeks after the first visit)</time_frame>
    <description>bacterial endotoxins reduction will be assessed by ELISA technique.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Necrotic Pulp</condition>
  <arm_group>
    <arm_group_label>Calcium Hydroxide Mixed With Chlorhexidin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>efficacy of calcium hydroxide and 2 % chlorhexidine gel and combination of both on the anaerobic bacteria, It was clear from the study that calcium hydroxide had limited efficacy against facultative anaerobes, but effective against obligate anaerobes while chlorhexidine only and combination group were effective against all species of anaerobic bacteria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calcium Hydroxide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The antimicrobial activity of calcium hydroxide Ca(OH)2 is related to the release of hydroxyl ions in an aqueous environment leading to damage in the bacterial cytoplasmic membrane, protein denaturation and DNA damage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Mechanical preparation without intracanal medications.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorhexidine 2% gel - Calcium Hydroxide Paste - Non-Setting</intervention_name>
    <description>Calcium Hydroxide Mixed With Chlorhexidin efficacy of calcium hydroxide and 2 % chlorhexidine gel and combination of both on the anaerobic bacteria, It was clear from the study that calcium hydroxide had limited efficacy against facultative anaerobes, but effective against obligate anaerobes while chlorhexidine only and combination group were effective against all species of anaerobic bacteria</description>
    <arm_group_label>Calcium Hydroxide Mixed With Chlorhexidin</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>CHX gel</other_name>
    <other_name>Ca(OH)2 paste</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium Hydroxide Paste - Non-Setting</intervention_name>
    <description>Calcium Hydroxide The antimicrobial activity of calcium hydroxide Ca(OH)2 is related to the release of hydroxyl ions in an aqueous environment leading to damage in the bacterial cytoplasmic membrane, protein denaturation and DNA damage</description>
    <arm_group_label>Calcium Hydroxide</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Ca(OH)2 intracanal medication</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients in Good Health(American Society Of Anaesthesiology Class II or higher).&#xD;
&#xD;
          -  Adult patients from both genders older than 18-50 years old suffering from chronic&#xD;
             periapical periodontitis with necrotic pulp.&#xD;
&#xD;
          -  single rooted teeth (maxillary and mandibular).&#xD;
&#xD;
          -  Patients who can understand numerical rating scale (NRS)&#xD;
&#xD;
          -  Patients able to sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Vital tooth.&#xD;
&#xD;
          -  Patients having active pain in more than one tooth.&#xD;
&#xD;
          -  Patients who had taken analgesics in 12 hours preceding the preparation.&#xD;
&#xD;
          -  Any type of teeth with multi roots.&#xD;
&#xD;
          -  Pulp hyperemia or any other conditions other than pulp necrosis like pulpitis or&#xD;
             previously accessed teeth with temporary fillings and patients suffering from chronic&#xD;
             disease (systemic diseases).&#xD;
&#xD;
          -  Pregnant or mentally retarded patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherif Elkhodary, Lecturer of Endodontics</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Oral and dental Medicine - Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Olfat Shaker, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Pharmacy - Cairo University.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Geraldine M. Ahmed, ass. professor</last_name>
    <role>Study Director</role>
    <affiliation>Faculty of Oral and dental Medicine - Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohammed Saadi Alarbeed, master degree candidate</last_name>
    <phone>+201023455553</phone>
    <email>mohammed-saadi@dentistry.cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Geraldine M. Ahmed, ass. professor</last_name>
    <phone>+201226322227</phone>
    <email>geraldine.ahmed@dentistry.cu.edu.eg</email>
  </overall_contact_backup>
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    <citation>Singh, Ripu Daman, et al.</citation>
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  </reference>
  <reference>
    <citation>Estrela C, Holland R, Bernabe PF, de Souza V, Estrela CR. Antimicrobial potential of medicaments used in healing process in dogs' teeth with apical periodontitis. Braz Dent J. 2004;15(3):181-5. doi: 10.1590/s0103-64402004000300003. Epub 2005 Mar 18.</citation>
    <PMID>15798819</PMID>
  </reference>
  <reference>
    <citation>Schafer E, Bossmann K. Antimicrobial efficacy of chlorhexidine and two calcium hydroxide formulations against Enterococcus faecalis. J Endod. 2005 Jan;31(1):53-6. doi: 10.1097/01.don.0000134209.28874.1c.</citation>
    <PMID>15614008</PMID>
  </reference>
  <reference>
    <citation>Haenni S, Schmidlin PR, Mueller B, Sener B, Zehnder M. Chemical and antimicrobial properties of calcium hydroxide mixed with irrigating solutions. Int Endod J. 2003 Feb;36(2):100-5. doi: 10.1046/j.1365-2591.2003.00629.x.</citation>
    <PMID>12657153</PMID>
  </reference>
  <reference>
    <citation>Gomes BP, Vianna ME, Zaia AA, Almeida JF, Souza-Filho FJ, Ferraz CC. Chlorhexidine in endodontics. Braz Dent J. 2013;24(2):89-102. doi: 10.1590/0103-6440201302188.</citation>
    <PMID>23780357</PMID>
  </reference>
  <reference>
    <citation>Sinha N, Patil S, Dodwad PK, Patil AC, Singh B. Evaluation of antimicrobial efficacy of calcium hydroxide paste, chlorhexidine gel, and a combination of both as intracanal medicament: An in vivo comparative study. J Conserv Dent. 2013 Jan;16(1):65-70. doi: 10.4103/0972-0707.105302.</citation>
    <PMID>23349580</PMID>
  </reference>
  <reference>
    <citation>Sousa EL, Martinho FC, Nascimento GG, Leite FR, Gomes BP. Quantification of endotoxins in infected root canals and acute apical abscess exudates: monitoring the effectiveness of root canal procedures in the reduction of endotoxins. J Endod. 2014 Feb;40(2):177-81. doi: 10.1016/j.joen.2013.10.008. Epub 2013 Dec 10.</citation>
    <PMID>24461400</PMID>
  </reference>
  <reference>
    <citation>Adl A, Motamedifar M, Shams MS, Mirzaie A. Clinical investigation of the effect of calcium hydroxide intracanal dressing on bacterial lipopolysaccharide reduction from infected root canals. Aust Endod J. 2015 Apr;41(1):12-6. doi: 10.1111/aej.12054. Epub 2013 Dec 13.</citation>
    <PMID>24330326</PMID>
  </reference>
  <reference>
    <citation>Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.</citation>
    <PMID>23657409</PMID>
  </reference>
  <reference>
    <citation>Khattak, Yasir Khan, Shafqat Ali Shah, and Fayaz Alam.</citation>
  </reference>
  <reference>
    <citation>Asgary S, Eghbal MJ. Treatment outcomes of pulpotomy in permanent molars with irreversible pulpitis using biomaterials: a multi-center randomized controlled trial. Acta Odontol Scand. 2013 Jan;71(1):130-6. doi: 10.3109/00016357.2011.654251. Epub 2012 Feb 20.</citation>
    <PMID>22339289</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>July 18, 2017</last_update_submitted>
  <last_update_submitted_qc>July 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohammed Saadi Alarbeed</investigator_full_name>
    <investigator_title>master candidate at endodontic department faculty of oral and dental medicine CU</investigator_title>
  </responsible_party>
  <keyword>Calcium hydroxide intracanal medication</keyword>
  <keyword>Ca(OH)2 intracanal medication</keyword>
  <keyword>Chlorhexidene gel</keyword>
  <keyword>CHX gel</keyword>
  <keyword>Root canal treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Pulp Necrosis</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_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/NCT03009006
org study id: CEBC-CU-2016-10-147
nct id: NCT03009006
lead sponsor: 
has dmc: No
The aim of this prospective in vivo randomized clinical trial to evaluate influence of
      combination of calcium Hydroxide (CALCIPAST Paste, Poland) and chlorhexidine Gel 2%
      (Gluco-Chex 2%, Cerkamed, Poland) in comparison to calcium hydroxide paste (CALCIPAST Paste,
      Poland) as Intracanal Medication on post operative pain (incidence, degree, duration) and
      reduction of bacterial endotoxins (quantitative) after endodontic treatment in single rooted
      necrotic teeth.

      According to the inclusion criteria the patients enrolled in the study and allocated randomly
      into three groups either combination of calcium hydroxide paste intracanal medication with 2%
      chlorhexidine gel. (group A) or calcium hydroxide paste intracanal medication only (group B)
      or mechanical preparation without intracanal medications (group C) the endodontic treatment
      is done at two visits.

      The samples of endotoxin divided into three groups: after access (S1), after mechanical
      instrumentations (S2), after removal intracanal medication (S3), all samples taken by a
      sterile paper points introduced in the root canal for the working length for 60 seconds.

      firstly the patient's medical and dental history is taken. the patients assign on informed
      consent. and then anaesthetized and access cavity performed and root canal preparation is
      done by Revo-s system then irrigation and intracanal medication placement inside to canal.
      the patient's record the post operative pain in sheet with NRS after 4, 24, 48 hours and 2
      weeks after first visit. the operator will recall the patient to check the records

      second visit After 2 weeks from application of ICM, rubber dam will be applied then removal
      of the temporary dressing, then a sterile paper point (S3) will be introduced into the canals
      after irrigation and removal of the remnants of the intracanal medicament with the saline
      solution.

        -  Removal of the paper sample to determine the endotoxin concentration.

        -  The canals will be obturated by single cone technique using gutta percha point tapered
           0.4% (Gutta percha point, Revo-S MicroMega CO., LTD, France) corresponding to the final
           apical size of the file and the root canal sealer will be resin sealer (Adseal, META
           BIOMED CO., LTD, Korea).

        -  Pain will be assessed by numerical pain rating scale (NRS) after 14 days from the first
           visit (at the day of the Obturation) before the beginning of Obturation.
Medical and dental history: diagnostic charts will be collected in a case report from by the
      investigators and confirmed for eligibility with the assistant supervisor.

      Radiographic examination: preoperative radiographs will be taken to examine the tooth
      structure, caries detection, periapical status.

      Clinical examination: intraoral examination include visual examination for caries,
      restorations, swelling, fistula, mobility, percussion were done.

      Diagnostic criteria for necrotic tooth:

        1. The patient marks moderate to severe pain on the numerical rating scale (NRS)a
           horizontal line of 11 marks and 10 intervals each takes number form 0 - 10 0 reading
           represents "no pain", 1- 3 readings represent "mild pain", 4- 6 readings represent
           "moderate pain", 7- 10 readings represent "severe pain".

           (recording baseline degree of pain preoperatively before initiating the endodontic
           treatment ) All step will done by operator.

           The measurement time will be at 4 hours, 24 hours, and 48 hours and after 14 days. (Day
           of Obturation)

        2. The patient not responding to electric pulp tester at higher level than the
           contralateral tooth or the adjacent tooth if the contralateral one is missing.

        3. Preoperative periapical x- ray film is done to detect any periapical changes.

      Intervention:

      Forty five patients will include were allocated by random or by chance to receive several
      clinical interventions and one of these interventions was control (Group A) where the
      patients did not receive any intracanal medication, (Group B) where the patients receive
      intracanal medication calcium hydroxide (CALCIPAST Paste, (Poland) and chlorhexidine 2 % gel.
      (Gluco-Chex 2%, Cerkamed, Poland), (Group C) calcium hydroxide paste only CALCIPAST Paste
      (Poland).

      Procedure steps:

      At the 1st appointment.

        -  Each patient will be given a numerical pain rating scale chart in order to rate his /her
           presenting pain as preoperative pain

        -  Anesthesia will be done with Carpule 3M™ ESPE™ Ubistesin™ Articaine HCI 4% & Adrenaline
           1:100,000 3M Australia the tooth with decayed using a standard dental aspirating
           syringe.

        -  After diagnosis disinfecting the tooth surface by 30% H2O2 (Perfect Medical, Egypt)
           followed by 2.5% NaOCl inactivated with sodium thiosulfate (El Nasr CO. for
           pharmaceuticals and chemicals).

        -  Access cavity will do under rubber dam isolation and with Sterile burs for access cavity
           preparation with distilled water as a coolant and flaring will done by endo-z bur.

        -  If successful anesthesia occurs, working length will be determined with an apex locator
           (Root ZX, J.Morita, Irvine, California, USA.) then confirmed with intraoral periapical
           radiograph (Kodac Dental film, speed D, size 2, Carestream Health, Rochester, NY, USA)
           to confirm the length to be 0.5-1 mm shorter than radiographic apex.

        -  The first sample of endotoxin (S1) is taken by a sterile paper points after access
           cavity preparation and introduced in the root canal for the working length for 60
           seconds.

        -  The sample is then placed in a pyrogenic free plastic tube and frozen to negative 200c
           for endotoxin determination by LAL test.

        -  Canal instrumentation will be done using NiTi rotary files system (Revo-S MicroMega,
           France) in an endodontic motor (X-Smart, Dentsply Maillefer, USA.) according to the
           manufacturer instructions to ensure adequate space for placement of the intracanal
           medicaments and proper removal of bacteria and debris, till size AS 35 file. The rotary
           files will be introduced inside the canal with EDTA gel (MD-Chelcream, META BIOMED CO.,
           LTD, Korea) as lubricant.

        -  The irrigant solution will be NaOCl with concentration 2.5% for its tissue dissolving
           properties between each file and will be delivered by disposable plastic syringe.

        -  Another sample (S2) will be taken after the cleaning and shaping and before placing the
           intracanal medications by sterile paper point for endotoxin determination.

        -  The first group will be subjected to combined therapy of both calcium hydroxide
           intracanal medication CALCIPAST Paste (Poland), with 2% chlorhexidine gel intracanal
           medication (Gluco-Chex 2%, Cerkamed, Poland) after the cleaning and shaping for 2 weeks
           period.

        -  The second group will be subjected to calcium hydroxide intracanal medication alone for
           2 weeks period after the cleaning and shaping. Calcium hydroxide will be in form of
           ready-made paste in a measured special syringe CALCIPAST (Poland).

        -  The third group will receive plain cotton with temporary filling without any intracanal
           medication.

        -  Placement of the intracanal medications by lentuolo spiral by low speed hand piece and
           condensed with paper points.

        -  Temporary filling is done by glass ionmer filling to ensure proper sealing with no
           leakage of any oral fluids inside the root canal, which may disturb the action of the
           intracanal medication.

        -  Pain will be assessed by numerical pain rating scale (NRS) will be given to each patient
           to complete a t home at the specified times at 4, 24, 48 hours after the first visit.

      At the 2nd appointment:

        -  After 2 weeks from application of ICM, rubber dam will be applied then removal of the
           temporary dressing by following the previous infection control protocol, then a sterile
           paper point (S3) will be introduced into the canals after irrigation and removal of the
           remnants of the intracanal medicament with the saline solution.

        -  Removal of the paper sample to determine the endotoxin concentration.

        -  The canals will be obturated by single cone technique using gutta percha point tapered
           0.4% (Gutta percha point, Revo-S MicroMega CO., LTD, France) corresponding to the final
           apical size of the file and the root canal sealer will be resin sealer (Adseal, META
           BIOMED CO., LTD, Korea).

        -  Pain will be assessed by numerical pain rating scale (NRS) after 14 days from the first
           visit (at the day of the Obturation) before the beginning of Obturation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: postoperative pain
time frame: 4, 24, 48 hrs and 2 weeks after completion of treatment
description: intensity of postoperative pain between visits by numerical Rating Scale (0- 10)
measure: bacterial endotoxins reductions
time frame: After access cavity, after mechanical preparation and after removal of intracanal medication (2 weeks after the first visit)
description: bacterial endotoxins reduction will be assessed by ELISA technique.
arm group label: Calcium Hydroxide Mixed With Chlorhexidin
arm group type: Experimental
description: efficacy of calcium hydroxide and 2 % chlorhexidine gel and combination of both on the anaerobic bacteria, It was clear from the study that calcium hydroxide had limited efficacy against facultative anaerobes, but effective against obligate anaerobes while chlorhexidine only and combination group were effective against all species of anaerobic bacteria.
arm group label: Calcium Hydroxide
arm group type: Experimental
description: The antimicrobial activity of calcium hydroxide Ca(OH)2 is related to the release of hydroxyl ions in an aqueous environment leading to damage in the bacterial cytoplasmic membrane, protein denaturation and DNA damage
arm group label: Placebo
arm group type: Placebo Comparator
description: Mechanical preparation without intracanal medications.
intervention type: Drug
intervention name: Chlorhexidine 2% gel - Calcium Hydroxide Paste - Non-Setting
description: Calcium Hydroxide Mixed With Chlorhexidin efficacy of calcium hydroxide and 2 % chlorhexidine gel and combination of both on the anaerobic bacteria, It was clear from the study that calcium hydroxide had limited efficacy against facultative anaerobes, but effective against obligate anaerobes while chlorhexidine only and combination group were effective against all species of anaerobic bacteria
arm group label: Calcium Hydroxide Mixed With Chlorhexidin
arm group label: Placebo
other name: CHX gel
other name: Ca(OH)2 paste
intervention type: Drug
intervention name: Calcium Hydroxide Paste - Non-Setting
description: Calcium Hydroxide The antimicrobial activity of calcium hydroxide Ca(OH)2 is related to the release of hydroxyl ions in an aqueous environment leading to damage in the bacterial cytoplasmic membrane, protein denaturation and DNA damage
arm group label: Calcium Hydroxide
arm group label: Placebo
other name: Ca(OH)2 intracanal medication
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sherif Elkhodary, Lecturer of Endodontics
role: Study Chair
affiliation: Faculty of Oral and dental Medicine - Cairo University
last name: Olfat Shaker, Professor
role: Principal Investigator
affiliation: Faculty of Pharmacy - Cairo University.
last name: Geraldine M. Ahmed, ass. professor
role: Study Director
affiliation: Faculty of Oral and dental Medicine - Cairo University
last name: Mohammed Saadi Alarbeed, master degree candidate
phone: +201023455553
email: mohammed-saadi@dentistry.cu.edu.eg
last name: Geraldine M. Ahmed, ass. professor
phone: +201226322227
email: geraldine.ahmed@dentistry.cu.edu.eg
citation: Singh, Ripu Daman, et al.
citation: Walton RE, Holton IF Jr, Michelich R. Calcium hydroxide as an intracanal medication: effect on posttreatment pain. J Endod. 2003 Oct;29(10):627-9. doi: 10.1097/00004770-200310000-00003.
PMID: 14606782
citation: Siqueira JF Jr, Rocas IN. Clinical implications and microbiology of bacterial persistence after treatment procedures. J Endod. 2008 Nov;34(11):1291-1301.e3. doi: 10.1016/j.joen.2008.07.028. Epub 2008 Sep 17.
PMID: 18928835
citation: KAKEHASHI S, STANLEY HR, FITZGERALD RJ. THE EFFECTS OF SURGICAL EXPOSURES OF DENTAL PULPS IN GERM-FREE AND CONVENTIONAL LABORATORY RATS. Oral Surg Oral Med Oral Pathol. 1965 Sep;20:340-9. doi: 10.1016/0030-4220(65)90166-0. No abstract available.
PMID: 14342926
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PMID: 16631834
citation: Gu LS, Kim JR, Ling J, Choi KK, Pashley DH, Tay FR. Review of contemporary irrigant agitation techniques and devices. J Endod. 2009 Jun;35(6):791-804. doi: 10.1016/j.joen.2009.03.010.
PMID: 19482174
citation: Cardoso MG, de Oliveira LD, Koga-Ito CY, Jorge AO. Effectiveness of ozonated water on Candida albicans, Enterococcus faecalis, and endotoxins in root canals. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Mar;105(3):e85-91. doi: 10.1016/j.tripleo.2007.10.006.
PMID: 18280954
citation: Vianna ME, Horz HP, Conrads G, Zaia AA, Souza-Filho FJ, Gomes BP. Effect of root canal procedures on endotoxins and endodontic pathogens. Oral Microbiol Immunol. 2007 Dec;22(6):411-8. doi: 10.1111/j.1399-302X.2007.00379.x.
PMID: 17949345
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PMID: 2094761
citation: Oliveira LD, Carvalho CA, Carvalho AS, Alves Jde S, Valera MC, Jorge AO. Efficacy of endodontic treatment for endotoxin reduction in primarily infected root canals and evaluation of cytotoxic effects. J Endod. 2012 Aug;38(8):1053-7. doi: 10.1016/j.joen.2012.04.015. Epub 2012 Jun 8.
PMID: 22794204
citation: Valera MC, da Rosa JA, Maekawa LE, de Oliveira LD, Carvalho CA, Koga-Ito CY, Jorge AO. Action of propolis and medications against Escherichia coli and endotoxin in root canals. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Oct;110(4):e70-4. doi: 10.1016/j.tripleo.2010.01.029.
PMID: 20868987
citation: Bystrom A, Sundqvist G. The antibacterial action of sodium hypochlorite and EDTA in 60 cases of endodontic therapy. Int Endod J. 1985 Jan;18(1):35-40. doi: 10.1111/j.1365-2591.1985.tb00416.x. No abstract available.
PMID: 3922900
citation: Dametto FR, Ferraz CC, Gomes BP, Zaia AA, Teixeira FB, de Souza-Filho FJ. In vitro assessment of the immediate and prolonged antimicrobial action of chlorhexidine gel as an endodontic irrigant against Enterococcus faecalis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Jun;99(6):768-72. doi: 10.1016/j.tripleo.2004.08.026.
PMID: 15897866
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PMID: 8688650
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PMID: 9823122
citation: Pinheiro ET, Gomes BP, Ferraz CC, Sousa EL, Teixeira FB, Souza-Filho FJ. Microorganisms from canals of root-filled teeth with periapical lesions. Int Endod J. 2003 Jan;36(1):1-11. doi: 10.1046/j.1365-2591.2003.00603.x.
PMID: 12656508
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PMID: 3522851
citation: Ferraz CC, Gomes BP, Zaia AA, Teixeira FB, Souza-Filho FJ. In vitro assessment of the antimicrobial action and the mechanical ability of chlorhexidine gel as an endodontic irrigant. J Endod. 2001 Jul;27(7):452-5. doi: 10.1097/00004770-200107000-00004.
PMID: 11503994
citation: Siqueira JF Jr, de Uzeda M. Intracanal medicaments: evaluation of the antibacterial effects of chlorhexidine, metronidazole, and calcium hydroxide associated with three vehicles. J Endod. 1997 Mar;23(3):167-9. doi: 10.1016/S0099-2399(97)80268-3.
PMID: 9594757
citation: Sukawat C, Srisuwan T. A comparison of the antimicrobial efficacy of three calcium hydroxide formulations on human dentin infected with Enterococcus faecalis. J Endod. 2002 Feb;28(2):102-4. doi: 10.1097/00004770-200202000-00013.
PMID: 11833679
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PMID: 12702121
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PMID: 8243347
citation: Heling I, Steinberg D, Kenig S, Gavrilovich I, Sela MN, Friedman M. Efficacy of a sustained-release device containing chlorhexidine and Ca(OH)2 in preventing secondary infection of dentinal tubules. Int Endod J. 1992 Jan;25(1):20-4. doi: 10.1111/j.1365-2591.1992.tb00944.x.
PMID: 1399050
citation: Salzgeber RM, Brilliant JD. An in vivo evaluation of the penetration of an irrigating solution in root canals. J Endod. 1977 Oct;3(10):394-8. doi: 10.1016/S0099-2399(77)80172-6. No abstract available.
PMID: 270543
citation: Basrani B, Tjaderhane L, Santos JM, Pascon E, Grad H, Lawrence HP, Friedman S. Efficacy of chlorhexidine- and calcium hydroxide-containing medicaments against Enterococcus faecalis in vitro. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Nov;96(5):618-24. doi: 10.1016/s1079-2104(03)00166-5.
PMID: 14600699
citation: Evans MD, Baumgartner JC, Khemaleelakul SU, Xia T. Efficacy of calcium hydroxide: chlorhexidine paste as an intracanal medication in bovine dentin. J Endod. 2003 May;29(5):338-9. doi: 10.1097/00004770-200305000-00005.
PMID: 12775006
citation: Estrela C, Holland R, Bernabe PF, de Souza V, Estrela CR. Antimicrobial potential of medicaments used in healing process in dogs' teeth with apical periodontitis. Braz Dent J. 2004;15(3):181-5. doi: 10.1590/s0103-64402004000300003. Epub 2005 Mar 18.
PMID: 15798819
citation: Schafer E, Bossmann K. Antimicrobial efficacy of chlorhexidine and two calcium hydroxide formulations against Enterococcus faecalis. J Endod. 2005 Jan;31(1):53-6. doi: 10.1097/01.don.0000134209.28874.1c.
PMID: 15614008
citation: Haenni S, Schmidlin PR, Mueller B, Sener B, Zehnder M. Chemical and antimicrobial properties of calcium hydroxide mixed with irrigating solutions. Int Endod J. 2003 Feb;36(2):100-5. doi: 10.1046/j.1365-2591.2003.00629.x.
PMID: 12657153
citation: Gomes BP, Vianna ME, Zaia AA, Almeida JF, Souza-Filho FJ, Ferraz CC. Chlorhexidine in endodontics. Braz Dent J. 2013;24(2):89-102. doi: 10.1590/0103-6440201302188.
PMID: 23780357
citation: Sinha N, Patil S, Dodwad PK, Patil AC, Singh B. Evaluation of antimicrobial efficacy of calcium hydroxide paste, chlorhexidine gel, and a combination of both as intracanal medicament: An in vivo comparative study. J Conserv Dent. 2013 Jan;16(1):65-70. doi: 10.4103/0972-0707.105302.
PMID: 23349580
citation: Sousa EL, Martinho FC, Nascimento GG, Leite FR, Gomes BP. Quantification of endotoxins in infected root canals and acute apical abscess exudates: monitoring the effectiveness of root canal procedures in the reduction of endotoxins. J Endod. 2014 Feb;40(2):177-81. doi: 10.1016/j.joen.2013.10.008. Epub 2013 Dec 10.
PMID: 24461400
citation: Adl A, Motamedifar M, Shams MS, Mirzaie A. Clinical investigation of the effect of calcium hydroxide intracanal dressing on bacterial lipopolysaccharide reduction from infected root canals. Aust Endod J. 2015 Apr;41(1):12-6. doi: 10.1111/aej.12054. Epub 2013 Dec 13.
PMID: 24330326
citation: Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.
PMID: 23657409
citation: Khattak, Yasir Khan, Shafqat Ali Shah, and Fayaz Alam.
citation: Asgary S, Eghbal MJ. Treatment outcomes of pulpotomy in permanent molars with irreversible pulpitis using biomaterials: a multi-center randomized controlled trial. Acta Odontol Scand. 2013 Jan;71(1):130-6. doi: 10.3109/00016357.2011.654251. Epub 2012 Feb 20.
PMID: 22339289
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohammed Saadi Alarbeed
investigator title: master candidate at endodontic department faculty of oral and dental medicine CU
mesh term: Dental Pulp Necrosis
mesh term: Necrosis
mesh term: Calcium, Dietary
mesh term: Chlorhexidine
mesh term: Calcium
sharing ipd: No