<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/NCT04481971</url>
  </required_header>
  <id_info>
    <org_study_id>E-20-4818</org_study_id>
    <nct_id>NCT04481971</nct_id>
  </id_info>
  <brief_title>A Comparison of Two Different Single Doses of Prednisolone on Endodontic Inter-appointment Pain</brief_title>
  <official_title>Comparative Evaluation of the Effectiveness of Premedication With Two Different Single Doses of Prednisolone on Inter-appointment Pain in Symptomatic Patients With Irreversible Pulpitis: a Double-blind Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Saud University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Saud 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 purpose of this prospective randomized, double-blind, placebo-controlled study is to&#xD;
      compare the efficiency of 2 different single doses of pre-operative oral prednisolone (20 &amp;&#xD;
      40 mg) for the control of inter-appointment endodontic pain in patients diagnosed with&#xD;
      symptomatic irreversible pulpitis. The tested null hypothesis is that there is no difference&#xD;
      in pain relief between the two doses.&#xD;
&#xD;
      Seventy-two patients presented for treatment at Dental University Hospital will be selected.&#xD;
      The inclusion criteria are systemically healthy patients (ASA classification I or II), with&#xD;
      no contraindications to corticosteroids (osteoporosis, systemic fungal infections, poorly&#xD;
      controlled insulin-dependent diabetes mellitus, ocular herpes simplex, primary glaucoma,&#xD;
      allergy to corticosteroids, ulcerative colitis, a compromised immune status, and major&#xD;
      psychosis). Patients under 18 years, pregnant or breast-feeding, took an analgesic agent&#xD;
      within the last 6 hours, those with un-restorable teeth, teeth with periodontal disease will&#xD;
      be excluded. Patients having mandibular molars with symptomatic irreversible pulpitis with&#xD;
      normal periapical area and moderate-severe preoperative pain (i.e. ≥ 34 mm on a visual analog&#xD;
      scale (VAS)) will be included.&#xD;
&#xD;
      Subjects will be randomly divided into 3 groups, namely placebo (control), 20 mg prednisolone&#xD;
      and 40 mg prednisolone according to a computerized random numbers. Each participant will&#xD;
      receive a single oral dose of either formulation (drug or placebo) 30 minutes before starting&#xD;
      endodontic treatment. All medications will be placed in identical containers and will be&#xD;
      coded; thus, both the operator and the patients will be blinded to the type of medication.&#xD;
      Endodontic treatment will be performed and canals will be instrumented to a minimum of size&#xD;
      30, .04 taper following the standardized protocol. Postoperative pain will be assessed by&#xD;
      using a visual analogue scale at 4, 12, 24 and 48 hours after initiation of therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 9, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2020</primary_completion_date>
  <phase>Phase 2</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, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in post-operative pain</measure>
    <time_frame>Change from baseline pain and pain at 4, 12, 24, and 48 hours after initiation of therapy</time_frame>
    <description>Questionnaire (visual analogue scale)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Endodontics</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>40 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisolone</intervention_name>
    <description>Tablets</description>
    <arm_group_label>20 mg</arm_group_label>
    <arm_group_label>40 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lactose in capsules gelatin</intervention_name>
    <description>Tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Systemically healthy patients (ASA classification I or II), with no contraindications&#xD;
             to corticosteroids (osteoporosis, systemic fungal infections, poorly controlled&#xD;
             insulin- dependent diabetes mellitus, ocular herpes simplex, primary glaucoma, allergy&#xD;
             to corticosteroids, ulcerative colitis, a compromised immune status, and major&#xD;
             psychosis).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years, pregnant or breast-feeding, took an analgesic agent within&#xD;
             the last 6 hours, those with un-restorable teeth, teeth with periodontal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Saud University</investigator_affiliation>
    <investigator_full_name>Sara Alsubait</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisolone</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/NCT04481971
org study id: E-20-4818
nct id: NCT04481971
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this prospective randomized, double-blind, placebo-controlled study is to
      compare the efficiency of 2 different single doses of pre-operative oral prednisolone (20 &
      40 mg) for the control of inter-appointment endodontic pain in patients diagnosed with
      symptomatic irreversible pulpitis. The tested null hypothesis is that there is no difference
      in pain relief between the two doses.

      Seventy-two patients presented for treatment at Dental University Hospital will be selected.
      The inclusion criteria are systemically healthy patients (ASA classification I or II), with
      no contraindications to corticosteroids (osteoporosis, systemic fungal infections, poorly
      controlled insulin-dependent diabetes mellitus, ocular herpes simplex, primary glaucoma,
      allergy to corticosteroids, ulcerative colitis, a compromised immune status, and major
      psychosis). Patients under 18 years, pregnant or breast-feeding, took an analgesic agent
      within the last 6 hours, those with un-restorable teeth, teeth with periodontal disease will
      be excluded. Patients having mandibular molars with symptomatic irreversible pulpitis with
      normal periapical area and moderate-severe preoperative pain (i.e. ≥ 34 mm on a visual analog
      scale (VAS)) will be included.

      Subjects will be randomly divided into 3 groups, namely placebo (control), 20 mg prednisolone
      and 40 mg prednisolone according to a computerized random numbers. Each participant will
      receive a single oral dose of either formulation (drug or placebo) 30 minutes before starting
      endodontic treatment. All medications will be placed in identical containers and will be
      coded; thus, both the operator and the patients will be blinded to the type of medication.
      Endodontic treatment will be performed and canals will be instrumented to a minimum of size
      30, .04 taper following the standardized protocol. Postoperative pain will be assessed by
      using a visual analogue scale at 4, 12, 24 and 48 hours after initiation of therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Change in post-operative pain
time frame: Change from baseline pain and pain at 4, 12, 24, and 48 hours after initiation of therapy
description: Questionnaire (visual analogue scale)
arm group label: 40 mg
arm group type: Experimental
arm group label: 20 mg
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Prednisolone
description: Tablets
arm group label: 20 mg
arm group label: 40 mg
intervention type: Drug
intervention name: lactose in capsules gelatin
description: Tablets
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: King Saud University
investigator full name: Sara Alsubait
investigator title: Associate Professor
mesh term: Prednisolone