<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/NCT03033147</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2016-12-163</org_study_id>
    <nct_id>NCT03033147</nct_id>
  </id_info>
  <brief_title>Effect of Preoperative Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain</brief_title>
  <official_title>Effect of Preoperative, Single-dose Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Double-Blind 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this prospective, randomized, placebo controlled study is to evaluate the effect&#xD;
      of a single preoperative dose of amoxicillin/clavulanic acid combination on post-operative&#xD;
      pain and swelling in adult 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;
      Prior to initiation of root canal treatment, eligible participants will be randomly assigned&#xD;
      to one of the following groups: experimental group (receiving 2 gm of amoxicillin/ clavulanic&#xD;
      acid orally 30 minutes before the treatment) or control group (receiving a placebo 30 minutes&#xD;
      before treatment).&#xD;
&#xD;
      Root canal treatment will then be carried out in a single visit.&#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>Completed</overall_status>
  <start_date type="Actual">October 18, 2019</start_date>
  <completion_date type="Actual">March 15, 2020</completion_date>
  <primary_completion_date type="Actual">March 15, 2020</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>Postoperative pain</measure>
    <time_frame>Up to 7 days after endodontic treatment</time_frame>
    <description>Postoperative pain will be measured by a numerical rating scale (NRS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Swelling</measure>
    <time_frame>Up to 7 days after endodontic treatment</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="Actual">72</enrollment>
  <condition>Symptomatic Periapical Periodontitis</condition>
  <arm_group>
    <arm_group_label>Amoxicillin/Clavulanate Potassium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Amoxicillin/Clavulanate Potassium 875 mg-125 mg orally 30 minutes before root canal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo 30 minutes before root canal treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet</intervention_name>
    <description>2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment</description>
    <arm_group_label>Amoxicillin/Clavulanate Potassium</arm_group_label>
    <other_name>Augmentin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral placebo</intervention_name>
    <description>placebo 30 minutes before root canal treatment</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with symptomatic apical periodontitis who do not have evidence of spreading&#xD;
             infection or systemic involvement.&#xD;
&#xD;
          -  Mandibular posterior teeth.&#xD;
&#xD;
          -  Patients with non-contributory systemic condition.&#xD;
&#xD;
          -  Patients who can understand pain scales and able to sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients allergic to penicillin.&#xD;
&#xD;
          -  Patients who have a draining sinus tract.&#xD;
&#xD;
          -  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>Nermeen NT Moushtaha, Postgraduate</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Suzan AW Amin, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shaimaa Gawdat, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University Faculty of Dentistry</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <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>Akbar I. Efficacy of Prophylactic use of Antibiotics to Avoid Flare up During Root Canal Treatment of Nonvital Teeth: A Randomized Clinical Trial. J Clin Diagn Res. 2015 Mar;9(3):ZC08-11. doi: 10.7860/JCDR/2015/12046.5620. Epub 2015 Mar 1.</citation>
    <PMID>25954695</PMID>
  </reference>
  <reference>
    <citation>Contardo L, Meneguzzi E, Cadenaro M, Di Lenarda R. Clinical evaluation of antibiotic prophylaxis before endodontic treatment of necrotic teeth. Minerva Stomatol. 2005 Mar;54(3):153-60. English, Italian.</citation>
    <PMID>15920447</PMID>
  </reference>
  <reference>
    <citation>Pickenpaugh L, Reader A, Beck M, Meyers WJ, Peterson LJ. Effect of prophylactic amoxicillin on endodontic flare-up in asymptomatic, necrotic teeth. J Endod. 2001 Jan;27(1):53-6. doi: 10.1097/00004770-200101000-00019.</citation>
    <PMID>11487166</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>June 15, 2021</last_update_submitted>
  <last_update_submitted_qc>June 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nermeen Naser Taleb Moushtaha</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Periapical Periodontitis</mesh_term>
  </condition_browse>
  <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>
  <!-- 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/NCT03033147
org study id: CEBC-CU-2016-12-163
nct id: NCT03033147
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of this prospective, randomized, placebo controlled study is to evaluate the effect
      of a single preoperative dose 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.

      Prior to initiation of root canal treatment, eligible participants will be randomly assigned
      to one of the following groups: experimental group (receiving 2 gm of amoxicillin/ clavulanic
      acid orally 30 minutes before the treatment) or control group (receiving a placebo 30 minutes
      before treatment).

      Root canal treatment will then be carried out in a single visit.

      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: Postoperative pain
time frame: Up to 7 days after endodontic treatment
description: Postoperative pain will be measured by a numerical rating scale (NRS).
measure: Swelling
time frame: Up to 7 days after endodontic treatment
description: The occurrence of Swelling will be measured by a questionnaire.
arm group label: Amoxicillin/Clavulanate Potassium
arm group type: Experimental
description: Amoxicillin/Clavulanate Potassium 875 mg-125 mg orally 30 minutes before root canal treatment
arm group label: Placebo
arm group type: Placebo Comparator
description: placebo 30 minutes before root canal treatment
intervention type: Drug
intervention name: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet
description: 2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment
arm group label: Amoxicillin/Clavulanate Potassium
other name: Augmentin
intervention type: Drug
intervention name: Oral placebo
description: placebo 30 minutes before root canal treatment
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Nermeen NT Moushtaha, Postgraduate
role: Principal Investigator
affiliation: Cairo University
last name: Suzan AW Amin, PhD
role: Study Chair
affiliation: Cairo University
last name: Shaimaa Gawdat, PhD
role: Study Director
affiliation: Cairo University
facility: 
country: Egypt
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: Akbar I. Efficacy of Prophylactic use of Antibiotics to Avoid Flare up During Root Canal Treatment of Nonvital Teeth: A Randomized Clinical Trial. J Clin Diagn Res. 2015 Mar;9(3):ZC08-11. doi: 10.7860/JCDR/2015/12046.5620. Epub 2015 Mar 1.
PMID: 25954695
citation: Contardo L, Meneguzzi E, Cadenaro M, Di Lenarda R. Clinical evaluation of antibiotic prophylaxis before endodontic treatment of necrotic teeth. Minerva Stomatol. 2005 Mar;54(3):153-60. English, Italian.
PMID: 15920447
citation: Pickenpaugh L, Reader A, Beck M, Meyers WJ, Peterson LJ. Effect of prophylactic amoxicillin on endodontic flare-up in asymptomatic, necrotic teeth. J Endod. 2001 Jan;27(1):53-6. doi: 10.1097/00004770-200101000-00019.
PMID: 11487166
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Nermeen Naser Taleb Moushtaha
investigator title: Principal Investigator
mesh term: Periodontitis
mesh term: Periapical Periodontitis
mesh term: Amoxicillin
mesh term: Clavulanic Acid
mesh term: Clavulanic Acids
mesh term: Amoxicillin-Potassium Clavulanate Combination