<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/NCT03007342</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2016-11-168</org_study_id>
    <nct_id>NCT03007342</nct_id>
  </id_info>
  <brief_title>Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain</brief_title>
  <official_title>Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial</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, randomized, placebo controlled study is to evaluate the effect&#xD;
      of amoxicillin/clavulanic acid combination on post-operative pain and swelling in adult&#xD;
      patient with symptomatic apical periodontitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Medical and dental history will be obtained from all patients participating in this trial.&#xD;
      Clinical and radiographic evaluation for each tooth included in this study will be recorded.&#xD;
&#xD;
      Clinical diagnosis of symptomatic apical periodontitis is to be confirmed.&#xD;
&#xD;
      After single-visit root canal treatment, eligible participants will be randomly assigned to&#xD;
      one of the following groups: experimental group (taking oral tablet 1000 mg of Amoxicillin/&#xD;
      clavulanic acid combination) or control group (taking placebo tablet).&#xD;
&#xD;
      Each patient will receive a 7-day diary to record postoperative pain and swelling.In case of&#xD;
      pain, the participant will be instructed to take an analgesic. Post-operative pain will be&#xD;
      measured as a primary outcome on 11-point scale (NRS) at the following time points: 6, 12,&#xD;
      24, 48, 72 hours and 7 days. The occurrence of swelling will be reported by participant as a&#xD;
      secondary outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <primary_completion_date type="Anticipated">December 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative pain.</measure>
    <time_frame>Up to 7 days after endodontic treatment</time_frame>
    <description>Post-operative pain will be measured by a numerical rating scale (NRS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Swelling</measure>
    <time_frame>7 days</time_frame>
    <description>The occurrence of Swelling will be measured by a questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">78</enrollment>
  <condition>Symptomatic Periapical Periodontitis</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral tablet 1000 mg of Amoxicillin/ clavulanic acid combination every 12 hours for five days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral tablet placebo every 12 hours for five days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet</intervention_name>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with symptomatic apical periodontitis who do not have evidence of spreading&#xD;
             infection or systemic involvement.&#xD;
&#xD;
          2. Mandibular posterior teeth with positive response to percussion.&#xD;
&#xD;
          3. Patients with non-contributory systemic condition.&#xD;
&#xD;
          4. Patients who can understand pain scales and able to sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients allergic to penicillin.&#xD;
&#xD;
          2. Patients who have a draining sinus tract.&#xD;
&#xD;
          3. Retreatment cases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Gomaa, Postgraduate</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>khaled Ezzat, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Suzan AW Amin, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Gomaa, Postgraduate</last_name>
    <phone>01006610083</phone>
    <email>ahmed.eltoukhy@dentistry.cu.edu.eg</email>
  </overall_contact>
  <reference>
    <citation>Henry M, Reader A, Beck M. Effect of penicillin on postoperative endodontic pain and swelling in symptomatic necrotic teeth. J Endod. 2001 Feb;27(2):117-23. doi: 10.1097/00004770-200102000-00016.</citation>
    <PMID>11491635</PMID>
  </reference>
  <reference>
    <citation>Fouad AF, Rivera EM, Walton RE. Penicillin as a supplement in resolving the localized acute apical abscess. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 May;81(5):590-5. doi: 10.1016/s1079-2104(96)80054-0.</citation>
    <PMID>8734709</PMID>
  </reference>
  <reference>
    <citation>Cope A, Francis N, Wood F, Mann MK, Chestnutt IG. Systemic antibiotics for symptomatic apical periodontitis and acute apical abscess in adults. Cochrane Database Syst Rev. 2014 Jun 26;(6):CD010136. doi: 10.1002/14651858.CD010136.pub2.</citation>
    <PMID>24967571</PMID>
  </reference>
  <reference>
    <citation>Arteagoitia MI, Barbier L, Santamaria J, Santamaria G, Ramos E. Efficacy of amoxicillin and amoxicillin/clavulanic acid in the prevention of infection and dry socket after third molar extraction. A systematic review and meta-analysis. Med Oral Patol Oral Cir Bucal. 2016 Jul 1;21(4):e494-504. doi: 10.4317/medoral.21139.</citation>
    <PMID>26946211</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Gomaa</investigator_full_name>
    <investigator_title>Post-graduate candidate</investigator_title>
  </responsible_party>
  <keyword>Amoxicillin</keyword>
  <keyword>clavulanic acid</keyword>
  <keyword>Periapical periodontitis</keyword>
  <keyword>Post-operative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Periapical Periodontitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Clavulanic Acid</mesh_term>
    <mesh_term>Clavulanic Acids</mesh_term>
    <mesh_term>Amoxicillin-Potassium Clavulanate Combination</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/NCT03007342
org study id: CEBC-CU-2016-11-168
nct id: NCT03007342
lead sponsor: 
has dmc: No
The aim of this prospective, randomized, placebo controlled study is to evaluate the effect
      of amoxicillin/clavulanic acid combination on post-operative pain and swelling in adult
      patient with symptomatic apical periodontitis.
Medical and dental history will be obtained from all patients participating in this trial.
      Clinical and radiographic evaluation for each tooth included in this study will be recorded.

      Clinical diagnosis of symptomatic apical periodontitis is to be confirmed.

      After single-visit root canal treatment, eligible participants will be randomly assigned to
      one of the following groups: experimental group (taking oral tablet 1000 mg of Amoxicillin/
      clavulanic acid combination) or control group (taking placebo tablet).

      Each patient will receive a 7-day diary to record postoperative pain and swelling.In case of
      pain, the participant will be instructed to take an analgesic. Post-operative pain will be
      measured as a primary outcome on 11-point scale (NRS) at the following time points: 6, 12,
      24, 48, 72 hours and 7 days. The occurrence of swelling will be reported by participant as a
      secondary outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Post-operative pain.
time frame: Up to 7 days after endodontic treatment
description: Post-operative pain will be measured by a numerical rating scale (NRS).
measure: Swelling
time frame: 7 days
description: The occurrence of Swelling will be measured by a questionnaire.
arm group label: Experimental group
arm group type: Experimental
description: Oral tablet 1000 mg of Amoxicillin/ clavulanic acid combination every 12 hours for five days.
arm group label: control group
arm group type: Placebo Comparator
description: Oral tablet placebo every 12 hours for five days.
intervention type: Drug
intervention name: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet
arm group label: Experimental group
intervention type: Drug
intervention name: Placebo
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ahmed Gomaa, Postgraduate
role: Principal Investigator
affiliation: Cairo University
last name: khaled Ezzat, Professor
role: Study Chair
affiliation: Cairo University
last name: Suzan AW Amin, PhD
role: Study Director
affiliation: Cairo University
last name: Ahmed Gomaa, Postgraduate
phone: 01006610083
email: ahmed.eltoukhy@dentistry.cu.edu.eg
citation: Henry M, Reader A, Beck M. Effect of penicillin on postoperative endodontic pain and swelling in symptomatic necrotic teeth. J Endod. 2001 Feb;27(2):117-23. doi: 10.1097/00004770-200102000-00016.
PMID: 11491635
citation: Fouad AF, Rivera EM, Walton RE. Penicillin as a supplement in resolving the localized acute apical abscess. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 May;81(5):590-5. doi: 10.1016/s1079-2104(96)80054-0.
PMID: 8734709
citation: Cope A, Francis N, Wood F, Mann MK, Chestnutt IG. Systemic antibiotics for symptomatic apical periodontitis and acute apical abscess in adults. Cochrane Database Syst Rev. 2014 Jun 26;(6):CD010136. doi: 10.1002/14651858.CD010136.pub2.
PMID: 24967571
citation: Arteagoitia MI, Barbier L, Santamaria J, Santamaria G, Ramos E. Efficacy of amoxicillin and amoxicillin/clavulanic acid in the prevention of infection and dry socket after third molar extraction. A systematic review and meta-analysis. Med Oral Patol Oral Cir Bucal. 2016 Jul 1;21(4):e494-504. doi: 10.4317/medoral.21139.
PMID: 26946211
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Gomaa
investigator title: Post-graduate candidate
mesh term: Periodontitis
mesh term: Periapical Periodontitis
mesh term: Amoxicillin
mesh term: Clavulanic Acid
mesh term: Clavulanic Acids
mesh term: Amoxicillin-Potassium Clavulanate Combination
sharing ipd: No