<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/NCT03033472</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2017-01-09</org_study_id>
    <nct_id>NCT03033472</nct_id>
  </id_info>
  <brief_title>Effect of Preoperative Clindamycin on Postoperative Endodontic Pain</brief_title>
  <official_title>Effect of Preoperative Single-dose Clindamycin 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>
  <brief_summary>
    <textblock>
      The aim of this prospective, randomized, placebo controlled study is to evaluate the effect&#xD;
      of clindamycin on post-operative pain and swelling in adult patient with symptomatic apical&#xD;
      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;
      Before root canal treatment, eligible participants will be randomly assigned to one of the&#xD;
      following groups: experimental group (taking 600 mg of clindamycin orally) or control group&#xD;
      (taking placebo ) 30 minutes before the start of the treatment. Single-visit root canal&#xD;
      treatment will be performed.&#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>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <masking_description>Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment</masking_description>
  </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">72</enrollment>
  <condition>Symptomatic Periapical Periodontitis</condition>
  <arm_group>
    <arm_group_label>Clindamycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>600 mg of Clindamycin 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 Orally before treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>600 mg Clindamycin orally</intervention_name>
    <description>600 mg Clindamycin orally 30 minutes before treatment</description>
    <arm_group_label>Clindamycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral Placebo</intervention_name>
    <description>Oral Placebo 30 minutes before treatment</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with symptomatic apical periodontitis and do not have evidence of spreading&#xD;
             infection or systemic involvement.&#xD;
&#xD;
          2. Mandibular posterior teeth.&#xD;
&#xD;
          3. Patients in good health.&#xD;
&#xD;
          4. Patients who can understand pain scales (NRS).&#xD;
&#xD;
          5. Patients able to sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have draining sinus tract.&#xD;
&#xD;
          2. Retreatment cases&#xD;
&#xD;
          3. Patients with weeping canals.&#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 SA El Sedawy, Post Graduate</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Suzan AW Wanees, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo Univertsity</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shaimaa Gawdat, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nermeen SA El Sedawy, Post Graduate</last_name>
    <phone>01002463414</phone>
    <email>nermeen.elsedaway@hotmail.com</email>
  </overall_contact>
  <results_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>
  </results_reference>
  <results_reference>
    <citation>Lindeboom JA, Frenken JW, Valkenburg P, van den Akker HP. The role of preoperative prophylactic antibiotic administration in periapical endodontic surgery: a randomized, prospective double-blind placebo-controlled study. Int Endod J. 2005 Dec;38(12):877-81. doi: 10.1111/j.1365-2591.2005.01030.x.</citation>
    <PMID>16343114</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nermeen Saeed Abdel Ghany El Sedawy</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>Clindamycin</mesh_term>
    <mesh_term>Clindamycin palmitate</mesh_term>
    <mesh_term>Clindamycin phosphate</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/NCT03033472
org study id: CEBC-CU-2017-01-09
nct id: NCT03033472
lead sponsor: 
The aim of this prospective, randomized, placebo controlled study is to evaluate the effect
      of clindamycin 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.

      Before root canal treatment, eligible participants will be randomly assigned to one of the
      following groups: experimental group (taking 600 mg of clindamycin orally) or control group
      (taking placebo ) 30 minutes before the start of the treatment. Single-visit root canal
      treatment will be performed.

      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)
masking description: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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: Clindamycin
arm group type: Experimental
description: 600 mg of Clindamycin orally 30 minutes before root canal treatment
arm group label: Placebo
arm group type: Placebo Comparator
description: placebo 30 minutes Orally before treatment
intervention type: Drug
intervention name: 600 mg Clindamycin orally
description: 600 mg Clindamycin orally 30 minutes before treatment
arm group label: Clindamycin
intervention type: Drug
intervention name: Oral Placebo
description: Oral Placebo 30 minutes before treatment
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Nermeen SA El Sedawy, Post Graduate
role: Principal Investigator
affiliation: Cairo University
last name: Suzan AW Wanees, PhD
role: Study Chair
affiliation: Cairo Univertsity
last name: Shaimaa Gawdat, PhD
role: Study Director
affiliation: Cairo University
last name: Nermeen SA El Sedawy, Post Graduate
phone: 01002463414
email: nermeen.elsedaway@hotmail.com
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: Lindeboom JA, Frenken JW, Valkenburg P, van den Akker HP. The role of preoperative prophylactic antibiotic administration in periapical endodontic surgery: a randomized, prospective double-blind placebo-controlled study. Int Endod J. 2005 Dec;38(12):877-81. doi: 10.1111/j.1365-2591.2005.01030.x.
PMID: 16343114
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Nermeen Saeed Abdel Ghany El Sedawy
investigator title: principal Investigator
mesh term: Periodontitis
mesh term: Periapical Periodontitis
mesh term: Clindamycin
mesh term: Clindamycin palmitate
mesh term: Clindamycin phosphate