<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/NCT03006107</url>
  </required_header>
  <id_info>
    <org_study_id>piroxicam _ Mepecaine</org_study_id>
    <nct_id>NCT03006107</nct_id>
  </id_info>
  <brief_title>Comparison of a Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine of Post-endodontic Pain</brief_title>
  <official_title>Comparison of the Efficacy of Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine for Management of Post-endodontic Pain in Posterior 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>
      to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative&#xD;
      pain associated with endodontic procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pain after endodontic treatment is commonly severe in the first 24 hours after treatment,&#xD;
      then it will reduce gradually until commonly disappearing after 7-10 days in most cases.&#xD;
      Since piroxicam has a half-life of 50 hours in the plasma, it will be effective in&#xD;
      controlling the most intense pain which occurs after endodontic treatment It appears that&#xD;
      optimal clinical benefits can be achieved by administering drugs such as local anesthetics&#xD;
      and NSAIDs before the onset of postoperative pain. Administering these drugs before a&#xD;
      surgical or an endodontic procedure may be of benefit for longer procedures or for minimizing&#xD;
      peripheral sensitization, which is a result of the cascade of inflammatory mediators that are&#xD;
      released by tissue injury and fuel the subsequent inflammatory process&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">November 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>The degree of postoperative pain at 6, 12, 24 and 48 postoperative hours which will be measured by Numeric Rate Scale , where the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results.</measure>
    <time_frame>up to 48 hours</time_frame>
    <description>Primary outcome will be collected by the operator through Numerical Rating Scale (NRS)20 which is an 11-point scale consisting of numbers from 0 through 10; 0 reading represents &quot;no pain&quot; , 1- 3 readings represent &quot;mild pain&quot; , 4- 6 readings represent &quot;moderate pain&quot; , 7- 10 readings represent &quot;severe pain&quot; No or mild pain will be considered as success while moderate or severe pain will be regarded as failure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Pulpitis - Irreversible</condition>
  <arm_group>
    <arm_group_label>intraligamentary injection of piroxicam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours .&#xD;
The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intraligamentary mepevacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>intraligamentary injection piroxicam</intervention_name>
    <description>intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours .&#xD;
The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone</description>
    <arm_group_label>intraligamentary injection of piroxicam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intraligamentary mepevacaine</intervention_name>
    <description>mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.</description>
    <arm_group_label>Intraligamentary mepevacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Medically free patients&#xD;
&#xD;
               -  Patient's age between 25-50 years.&#xD;
&#xD;
               -  Molar or premolar teeth diagnosed clinically and radiographically with&#xD;
                  irreversible pulpitis and symptomatic apical periodontitis.&#xD;
&#xD;
               -  Positive patient's acceptance for participation in the study.&#xD;
&#xD;
               -  Sex include both male and female.&#xD;
&#xD;
               -  Patients who can understand Numerical Rating Scale (NRS)&#xD;
&#xD;
               -  Patients able to sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Pregnancy or lactation in female patients&#xD;
&#xD;
               -  Medically compromised patients.&#xD;
&#xD;
               -  Patient with multiple teeth that required endodontic treatment to eliminate the&#xD;
                  possibility of pain referral.&#xD;
&#xD;
               -  Patient with fracture or mobile or mutilated teeth.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angie g Ghoneim, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Department of endodontics - Faculty of Oral and Dental medicine - CU</affiliation>
  </overall_official>
  <overall_official>
    <last_name>marwa ga ahmed, student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of endodontics - Faculty of Oral and Dental medicine - CU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>marwa ga ahmed, student</last_name>
    <phone>01286171420</phone>
    <email>marwa.ahmed@dentistry.cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sherif A El khodary, Lecturer</last_name>
    <phone>01006609198</phone>
  </overall_contact_backup>
  <reference>
    <citation>Penniston SG, Hargreaves KM. Evaluation of periapical injection of Ketorolac for management of endodontic pain. J Endod. 1996 Feb;22(2):55-9. doi: 10.1016/S0099-2399(96)80272-X.</citation>
    <PMID>8935018</PMID>
  </reference>
  <reference>
    <citation>Pharmacological Strategies to Control Post-operative Endodontic Pain. Dental Research Journal (Vol. 4, No. 2, Autumn-Winter 2007</citation>
  </reference>
  <reference>
    <citation>3. Building effective strategies for the management of endodontic pain. Endodontic Topics 2002, 3, 93-105</citation>
  </reference>
  <reference>
    <citation>Atbaei A, Mortazavi N. Prophylactic intraligamentary injection of piroxicam (feldene) for the management of post-endodontic pain in molar teeth with irreversible pulpitis. Aust Endod J. 2012 Apr;38(1):31-5. doi: 10.1111/j.1747-4477.2010.00274.x. Epub 2010 Oct 24.</citation>
    <PMID>22432824</PMID>
  </reference>
  <reference>
    <citation>Torabinejad M, Bakland LK. Prostaglandins: their possible role in the pathogenesis of pulpal and periapical diseases, part 2. J Endod. 1980 Oct;6(10):769-76. doi: 10.1016/S0099-2399(80)80107-5. No abstract available.</citation>
    <PMID>7005368</PMID>
  </reference>
  <reference>
    <citation>Cohen JS, Reader A, Fertel R, Beck M, Meyers WJ. A radioimmunoassay determination of the concentrations of prostaglandins E2 and F2alpha in painful and asymptomatic human dental pulps. J Endod. 1985 Aug;11(8):330-5. doi: 10.1016/s0099-2399(85)80039-x. No abstract available.</citation>
    <PMID>3863874</PMID>
  </reference>
  <reference>
    <citation>McNicholas S, Torabinejad M, Blankenship J, Bakland L. The concentration of prostaglandin E2 in human periradicular lesions. J Endod. 1991 Mar;17(3):97-100. doi: 10.1016/S0099-2399(06)81737-1.</citation>
    <PMID>1940730</PMID>
  </reference>
  <reference>
    <citation>Mehrvarzfar P, Abbott PV, Saghiri MA, Delvarani A, Asgar K, Lotfi M, Karamifar K, Kharazifard MJ, Khabazi H. Effects of three oral analgesics on postoperative pain following root canal preparation: a controlled clinical trial. Int Endod J. 2012 Jan;45(1):76-82. doi: 10.1111/j.1365-2591.2011.01950.x. Epub 2011 Sep 8.</citation>
    <PMID>21902704</PMID>
  </reference>
  <reference>
    <citation>Mehlisch DR. The efficacy of combination analgesic therapy in relieving dental pain. J Am Dent Assoc. 2002 Jul;133(7):861-71. doi: 10.14219/jada.archive.2002.0300.</citation>
    <PMID>12148679</PMID>
  </reference>
  <reference>
    <citation>Maccagno A, Di Giorgio EE, Caston OL, Sagasta CL. Double-blind controlled clinical trial of oral S-adenosylmethionine versus piroxicam in knee osteoarthritis. Am J Med. 1987 Nov 20;83(5A):72-7. doi: 10.1016/0002-9343(87)90855-2.</citation>
    <PMID>3318443</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 27, 2016</last_update_submitted>
  <last_update_submitted_qc>December 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Marwa Gamal Ahmed</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>Irreversible pulpitis</keyword>
  <keyword>Post endodontic pain</keyword>
  <keyword>Symptomatic pulpitis pain</keyword>
  <keyword>Single visit RCT pain</keyword>
  <keyword>Root canal treatment flare up</keyword>
  <keyword>Single dose piroxicam</keyword>
  <keyword>Intraligamentary piroxicam</keyword>
  <keyword>Intraligamentary mepecaine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulpitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Piroxicam</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/NCT03006107
org study id: piroxicam _ Mepecaine
nct id: NCT03006107
lead sponsor: 
has dmc: No
to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative
      pain associated with endodontic procedures.
The pain after endodontic treatment is commonly severe in the first 24 hours after treatment,
      then it will reduce gradually until commonly disappearing after 7-10 days in most cases.
      Since piroxicam has a half-life of 50 hours in the plasma, it will be effective in
      controlling the most intense pain which occurs after endodontic treatment It appears that
      optimal clinical benefits can be achieved by administering drugs such as local anesthetics
      and NSAIDs before the onset of postoperative pain. Administering these drugs before a
      surgical or an endodontic procedure may be of benefit for longer procedures or for minimizing
      peripheral sensitization, which is a result of the cascade of inflammatory mediators that are
      released by tissue injury and fuel the subsequent inflammatory process
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The degree of postoperative pain at 6, 12, 24 and 48 postoperative hours which will be measured by Numeric Rate Scale , where the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results.
time frame: up to 48 hours
description: Primary outcome will be collected by the operator through Numerical Rating Scale (NRS)20 which is an 11-point scale consisting of numbers from 0 through 10; 0 reading represents "no pain" , 1- 3 readings represent "mild pain" , 4- 6 readings represent "moderate pain" , 7- 10 readings represent "severe pain" No or mild pain will be considered as success while moderate or severe pain will be regarded as failure.
arm group label: intraligamentary injection of piroxicam
arm group type: Experimental
description: intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours .
The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone
arm group label: Intraligamentary mepevacaine
arm group type: Active Comparator
description: mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.
intervention type: Procedure
intervention name: intraligamentary injection piroxicam
description: intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours .
The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone
arm group label: intraligamentary injection of piroxicam
intervention type: Procedure
intervention name: Intraligamentary mepevacaine
description: mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.
arm group label: Intraligamentary mepevacaine
criteria: 
gender: All
minimum age: 25 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Angie g Ghoneim, Professor
role: Study Chair
affiliation: Department of endodontics - Faculty of Oral and Dental medicine - CU
last name: marwa ga ahmed, student
role: Principal Investigator
affiliation: Department of endodontics - Faculty of Oral and Dental medicine - CU
last name: marwa ga ahmed, student
phone: 01286171420
email: marwa.ahmed@dentistry.cu.edu.eg
last name: Sherif A El khodary, Lecturer
phone: 01006609198
citation: Penniston SG, Hargreaves KM. Evaluation of periapical injection of Ketorolac for management of endodontic pain. J Endod. 1996 Feb;22(2):55-9. doi: 10.1016/S0099-2399(96)80272-X.
PMID: 8935018
citation: Pharmacological Strategies to Control Post-operative Endodontic Pain. Dental Research Journal (Vol. 4, No. 2, Autumn-Winter 2007
citation: 3. Building effective strategies for the management of endodontic pain. Endodontic Topics 2002, 3, 93-105
citation: Atbaei A, Mortazavi N. Prophylactic intraligamentary injection of piroxicam (feldene) for the management of post-endodontic pain in molar teeth with irreversible pulpitis. Aust Endod J. 2012 Apr;38(1):31-5. doi: 10.1111/j.1747-4477.2010.00274.x. Epub 2010 Oct 24.
PMID: 22432824
citation: Torabinejad M, Bakland LK. Prostaglandins: their possible role in the pathogenesis of pulpal and periapical diseases, part 2. J Endod. 1980 Oct;6(10):769-76. doi: 10.1016/S0099-2399(80)80107-5. No abstract available.
PMID: 7005368
citation: Cohen JS, Reader A, Fertel R, Beck M, Meyers WJ. A radioimmunoassay determination of the concentrations of prostaglandins E2 and F2alpha in painful and asymptomatic human dental pulps. J Endod. 1985 Aug;11(8):330-5. doi: 10.1016/s0099-2399(85)80039-x. No abstract available.
PMID: 3863874
citation: McNicholas S, Torabinejad M, Blankenship J, Bakland L. The concentration of prostaglandin E2 in human periradicular lesions. J Endod. 1991 Mar;17(3):97-100. doi: 10.1016/S0099-2399(06)81737-1.
PMID: 1940730
citation: Mehrvarzfar P, Abbott PV, Saghiri MA, Delvarani A, Asgar K, Lotfi M, Karamifar K, Kharazifard MJ, Khabazi H. Effects of three oral analgesics on postoperative pain following root canal preparation: a controlled clinical trial. Int Endod J. 2012 Jan;45(1):76-82. doi: 10.1111/j.1365-2591.2011.01950.x. Epub 2011 Sep 8.
PMID: 21902704
citation: Mehlisch DR. The efficacy of combination analgesic therapy in relieving dental pain. J Am Dent Assoc. 2002 Jul;133(7):861-71. doi: 10.14219/jada.archive.2002.0300.
PMID: 12148679
citation: Maccagno A, Di Giorgio EE, Caston OL, Sagasta CL. Double-blind controlled clinical trial of oral S-adenosylmethionine versus piroxicam in knee osteoarthritis. Am J Med. 1987 Nov 20;83(5A):72-7. doi: 10.1016/0002-9343(87)90855-2.
PMID: 3318443
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Marwa Gamal Ahmed
investigator title: principal investigator
mesh term: Pulpitis
mesh term: Piroxicam
sharing ipd: No