<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/NCT03005522</url>
  </required_header>
  <id_info>
    <org_study_id>1611005004</org_study_id>
    <nct_id>NCT03005522</nct_id>
  </id_info>
  <brief_title>The Effects of Dexamethasone on the Time to Pain Resolution in Dental Periapical Abscess</brief_title>
  <official_title>The Effects of Dexamethasone on the Time to Pain Resolution in Dental Periapical Abscess</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An individual's quality of life can be seriously affected by the severity of dental pain. The&#xD;
      emergency department is a common place to find those seeking relief from their dental pain-&#xD;
      often times seeking removal of the affected tooth, dental anesthetic injections or oral pain&#xD;
      medications. There are a number of dental infections that cause this type of debilitating&#xD;
      pain. One such dental infection is termed periapical abscess. This infection involves the&#xD;
      tooth pulp. These infections can arise in three ways: introduction through a defect in the&#xD;
      enamel and dentin; from a periodontal pocket or an adjacent tooth; or hematogenous seeding of&#xD;
      the pulp from mechanical irritation. As this disease process continues there are a number of&#xD;
      complications including chronic pain and, more seriously, the spread of infection into deep&#xD;
      spaces which can be a life threatening condition.&#xD;
&#xD;
      The Emergency Department treatment of this infection includes pain control, antibiotics and&#xD;
      dental referral for ultimate management of the infection.&#xD;
&#xD;
      The purpose of our study is to investigate whether the addition of oral steroids will alter&#xD;
      the time until patient experiences improvement in their dental pain. Steroids are a commonly&#xD;
      used anti-inflammatory that is used in the Emergency Departmentfor the purpose of pain relief&#xD;
      from throat pain. As the pain from periapical infection is thought to be largely from the&#xD;
      pressure we speculate that the anti-inflammatory effects of steroids may decrease the&#xD;
      inflammation thus the pressure and may ultimately lead to a decrease in time until the&#xD;
      patient experiences some relief from their pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease Time of Oral Pain</measure>
    <time_frame>72 hours</time_frame>
    <description>The purpose of this study is to investigate whether the addition of oral steroids will alter the time until patient experiences improvement in their dental pain from an acute dental periapical abscess. The patients will be randomized to receive either dexamethasone or placebo. The patients will be contacted over a period 72 hours to assess their level of pain resolution.&#xD;
Pain was reported using a verbal numeric scale in which 10=maximum pain and 0=no pain</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Dental Research</condition>
  <condition>Pharmaceutical Preparations, Dental</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>dosed with placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10mg oral dexamethasone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral dexamethasone</intervention_name>
    <description>Patient will be dosed with either placebo or with the study drug, 10mg oral dexamethasone, to be administered by mouth one time in the ED</description>
    <arm_group_label>intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <description>dosed with placebo</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients included if they had clinical diagnosis of pulpitis/dental apical abscess and&#xD;
        physical exam revealed pain with percussion of the affected tooth/teeth plus or minus&#xD;
        evidence of periapical abscess (gingival erythema, swelling, draining pus). Written&#xD;
        informed consent was obtained from each patient prior to enrollment in the study.-&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Younger than 18 years old&#xD;
&#xD;
          2. Immunosuppression : HIV patient, transplant patient, chemotherapy&#xD;
&#xD;
          3. History of diabetes&#xD;
&#xD;
          4. Recent (&lt;1 month) or chronic steroid use&#xD;
&#xD;
          5. Hospitalization required due to intractable vomiting/pain&#xD;
&#xD;
          6. Pregnancy, self report&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noah Tolby, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner University Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <results_first_submitted>November 5, 2022</results_first_submitted>
  <results_first_submitted_qc>November 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 28, 2022</results_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Arizona</investigator_affiliation>
    <investigator_full_name>Noah Tolby</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periapical Abscess</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03005522/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>dosed with placebo&#xD;
Placebo Oral Capsule: dosed with placebo</description>
        </group>
        <group group_id="P2">
          <title>Intervention</title>
          <description>10mg oral dexamethasone&#xD;
oral dexamethasone: Patient will be dosed with either placebo or with the study drug, 10mg oral dexamethasone, to be administered by mouth one time in the ED</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>dosed with placebo&#xD;
Placebo Oral Capsule: dosed with placebo</description>
        </group>
        <group group_id="B2">
          <title>Intervention</title>
          <description>10mg oral dexamethasone&#xD;
oral dexamethasone: Patient will be dosed with either placebo or with the study drug, 10mg oral dexamethasone, to be administered by mouth one time in the ED</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="52"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.1" spread="10.8"/>
                    <measurement group_id="B2" value="33.9" spread="9.44"/>
                    <measurement group_id="B3" value="34.4" spread="10.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>data not collected on race or ethnicity</description>
          <population>data on race and ethnicity were not collected</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="25"/>
                    <count group_id="B2" value="27"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Decrease Time of Oral Pain</title>
        <description>The purpose of this study is to investigate whether the addition of oral steroids will alter the time until patient experiences improvement in their dental pain from an acute dental periapical abscess. The patients will be randomized to receive either dexamethasone or placebo. The patients will be contacted over a period 72 hours to assess their level of pain resolution.&#xD;
Pain was reported using a verbal numeric scale in which 10=maximum pain and 0=no pain</description>
        <time_frame>72 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>dosed with placebo&#xD;
Placebo Oral Capsule: dosed with placebo</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>10mg oral dexamethasone&#xD;
oral dexamethasone: Patient will be dosed with either placebo or with the study drug, 10mg oral dexamethasone, to be administered by mouth one time in the ED</description>
          </group>
        </group_list>
        <measure>
          <title>Decrease Time of Oral Pain</title>
          <description>The purpose of this study is to investigate whether the addition of oral steroids will alter the time until patient experiences improvement in their dental pain from an acute dental periapical abscess. The patients will be randomized to receive either dexamethasone or placebo. The patients will be contacted over a period 72 hours to assess their level of pain resolution.&#xD;
Pain was reported using a verbal numeric scale in which 10=maximum pain and 0=no pain</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At presentation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="8" upper_limit="10"/>
                    <measurement group_id="O2" value="9" lower_limit="8" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="2" upper_limit="7"/>
                    <measurement group_id="O2" value="4" lower_limit="2" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 12 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="3" upper_limit="8"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 24 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="7"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 48 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="0" upper_limit="7"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 72 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="7"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>72 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>dosed with placebo&#xD;
Placebo Oral Capsule: dosed with placebo</description>
        </group>
        <group group_id="E2">
          <title>Intervention</title>
          <description>10mg oral dexamethasone&#xD;
oral dexamethasone: Patient will be dosed with either placebo or with the study drug, 10mg oral dexamethasone, to be administered by mouth one time in the ED</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Noah Tolby</name_or_title>
      <organization>Banner University Medical Center</organization>
      <phone>520-694-8888</phone>
      <email>ntolby@aemrc.arizona.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03005522
org study id: 1611005004
nct id: NCT03005522
lead sponsor: 
has dmc: No
An individual's quality of life can be seriously affected by the severity of dental pain. The
      emergency department is a common place to find those seeking relief from their dental pain-
      often times seeking removal of the affected tooth, dental anesthetic injections or oral pain
      medications. There are a number of dental infections that cause this type of debilitating
      pain. One such dental infection is termed periapical abscess. This infection involves the
      tooth pulp. These infections can arise in three ways: introduction through a defect in the
      enamel and dentin; from a periodontal pocket or an adjacent tooth; or hematogenous seeding of
      the pulp from mechanical irritation. As this disease process continues there are a number of
      complications including chronic pain and, more seriously, the spread of infection into deep
      spaces which can be a life threatening condition.

      The Emergency Department treatment of this infection includes pain control, antibiotics and
      dental referral for ultimate management of the infection.

      The purpose of our study is to investigate whether the addition of oral steroids will alter
      the time until patient experiences improvement in their dental pain. Steroids are a commonly
      used anti-inflammatory that is used in the Emergency Departmentfor the purpose of pain relief
      from throat pain. As the pain from periapical infection is thought to be largely from the
      pressure we speculate that the anti-inflammatory effects of steroids may decrease the
      inflammation thus the pressure and may ultimately lead to a decrease in time until the
      patient experiences some relief from their pain.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Decrease Time of Oral Pain
time frame: 72 hours
description: The purpose of this study is to investigate whether the addition of oral steroids will alter the time until patient experiences improvement in their dental pain from an acute dental periapical abscess. The patients will be randomized to receive either dexamethasone or placebo. The patients will be contacted over a period 72 hours to assess their level of pain resolution.
Pain was reported using a verbal numeric scale in which 10=maximum pain and 0=no pain
arm group label: placebo
arm group type: Placebo Comparator
description: dosed with placebo
arm group label: intervention
arm group type: Active Comparator
description: 10mg oral dexamethasone
intervention type: Drug
intervention name: oral dexamethasone
description: Patient will be dosed with either placebo or with the study drug, 10mg oral dexamethasone, to be administered by mouth one time in the ED
arm group label: intervention
intervention type: Drug
intervention name: Placebo Oral Capsule
description: dosed with placebo
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Noah Tolby, MD
role: Principal Investigator
affiliation: University of Arizona
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Arizona
investigator full name: Noah Tolby
investigator title: Principle Investigator
mesh term: Periapical Abscess
mesh term: Dexamethasone
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 