<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/NCT04406883</url>
  </required_header>
  <id_info>
    <org_study_id>2093</org_study_id>
    <nct_id>NCT04406883</nct_id>
  </id_info>
  <brief_title>Effects of Simvastatin in the Prevention of Pain Experienced After Tooth Extraction</brief_title>
  <official_title>Effects of Simvastatin in the Prevention of Pain Experienced After Tooth Extraction. Double-blind Clinical Trials</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Islamic Azad University, Tehran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Islamic Azad University, Tehran</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atraumatic extraction of maxillary premolar teeth (on the Right, left side) was done;&#xD;
      Subsequently, the patients were randomly divided into two equal groups: A group (Extraction +&#xD;
      filled with a Simvastatin solution impregnated gelatin sponge) and B group (Extraction +&#xD;
      without Simvastatin solution impregnated gelatin sponge), were placed in one of the sockets;&#xD;
      the pain level is recorded according to the VAS scores at the intervals of before treatments,&#xD;
      also Postoperative analog pain scores were assessed in 30 minutes, 6 hours, 12 hours and 24&#xD;
      hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The method of procedure was performed by the same surgeon under local anesthesia (Lidocaine&#xD;
      2% with epinephrine 1:100,000, made by Darou Pakhsh Pharmaceutical Co; Tehran-Iran) to avoid&#xD;
      bias. All two first premolars were extracted carefully, have used periotome as a means of&#xD;
      atraumatic extraction that facilitated the removal of teeth with minimum damage to the&#xD;
      surrounding alveolar bone, teeth to be extracted should have minimum periapical changes&#xD;
      radiographically; with decreasing soft tissue reflection; the socket was tan gently irrigated&#xD;
      with normal saline and hemostasis was achieved. It must be noted that A group (Extraction +&#xD;
      Simvastatin filled with Simvastatin (Poursina Pharmaceutical Co. Tehran-Iran) solution&#xD;
      impregnated gelatin sponge (Maquira Industry Dental Products S.A. Brazil) and B group&#xD;
      (Extraction + without Simvastatin solution impregnated gelatin sponge), was placed in one of&#xD;
      the sockets.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2019</start_date>
  <completion_date type="Actual">February 29, 2020</completion_date>
  <primary_completion_date type="Actual">December 26, 2019</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>
    <intervention_model_description>This study is a Double-blind, Randomized, Parallel-group, split-mouth.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>This event was a double-blind study (neither the patients nor the clinicians were aware of the rinsing solution used). Consequently, all periods of treatment, clinical parameters were recorded by an examiner who was blinded to the kind of medication received by the subjects while another clinician gave treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain experienced by patients following the atraumatic tooth extraction, evaluated by using a visual analog pain scale within 24 hours.</measure>
    <time_frame>one day</time_frame>
    <description>The pain level is recorded according to the visual analogue scale (VAS) at the intervals of before treatments, also Postoperative analog pain scores were assessed in 30 minutes to 24 hours later.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>A (Simavastatin 10 mg with gelatin sponge graft)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A group: After atraumatic extraction, filled the tooth socket with Simvastatin10 mg solution impregnated gelatin sponge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B(Gelatin sponge graft )</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>B group: Following atraumatic extraction, put in the tooth socket with gelatin sponge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Extraction + filled with Simvastatin solution impregnated gelatin sponge</intervention_name>
    <description>All two first premolars were extracted carefully, have used periotome as a means of atraumatic extraction that facilitated the removal of teeth with minimum damage to the surrounding alveolar bone, teeth to be extracted should have minimum periapical changes radiographically; with decreasing soft tissue reflection; the socket was tan gently irrigated with normal saline and hemostasis was achieved. It must be noted that A group (Extraction + filled with Simvastatin (Poursina Pharmaceutical Co. Tehran-Iran) solution impregnated gelatin sponge (Maquira Industry Dental Products S.A. Brazil) and B group (Extraction + without Simvastatin solution impregnated gelatin sponge), was placed in one of the sockets.</description>
    <arm_group_label>A (Simavastatin 10 mg with gelatin sponge graft)</arm_group_label>
    <arm_group_label>B(Gelatin sponge graft )</arm_group_label>
    <other_name>Extraction + filled gelatin sponge</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy patients Age group 18-35 years Sulcular probing not more than 3 mm and no redness&#xD;
        The determination for extraction of teeth (two maxillary first premolars)for orthodontic&#xD;
        treatment A tooth requiring an atraumatic extraction technique.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Systemic diseases Smoking habits; pregnancy or breastfeeding Periodontitis; Teeth having&#xD;
        radiographically obvious large periapical Lesion(abscess/granuloma/cyst) T the history of&#xD;
        Chemotherapy Radiation therapy Periodontal and the use of any medicine (antibiotics;&#xD;
        steroids; non-steroidal anti-inflammatory drugs Allergy to Simvastatin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Amirhossein Farahmand</name>
      <address>
        <city>Tehran</city>
        <zip>19</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>March 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 24, 2020</last_update_submitted>
  <last_update_submitted_qc>May 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Islamic Azad University, Tehran</investigator_affiliation>
    <investigator_full_name>Amirhossein Farahmand</investigator_full_name>
    <investigator_title>director,clinical research</investigator_title>
  </responsible_party>
  <keyword>Pain Measurement;Tooth Extraction;Simvastatin.</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Simvastatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>will published</ipd_description>
  </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/NCT04406883
org study id: 2093
nct id: NCT04406883
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Atraumatic extraction of maxillary premolar teeth (on the Right, left side) was done;
      Subsequently, the patients were randomly divided into two equal groups: A group (Extraction +
      filled with a Simvastatin solution impregnated gelatin sponge) and B group (Extraction +
      without Simvastatin solution impregnated gelatin sponge), were placed in one of the sockets;
      the pain level is recorded according to the VAS scores at the intervals of before treatments,
      also Postoperative analog pain scores were assessed in 30 minutes, 6 hours, 12 hours and 24
      hours.
The method of procedure was performed by the same surgeon under local anesthesia (Lidocaine
      2% with epinephrine 1:100,000, made by Darou Pakhsh Pharmaceutical Co; Tehran-Iran) to avoid
      bias. All two first premolars were extracted carefully, have used periotome as a means of
      atraumatic extraction that facilitated the removal of teeth with minimum damage to the
      surrounding alveolar bone, teeth to be extracted should have minimum periapical changes
      radiographically; with decreasing soft tissue reflection; the socket was tan gently irrigated
      with normal saline and hemostasis was achieved. It must be noted that A group (Extraction +
      Simvastatin filled with Simvastatin (Poursina Pharmaceutical Co. Tehran-Iran) solution
      impregnated gelatin sponge (Maquira Industry Dental Products S.A. Brazil) and B group
      (Extraction + without Simvastatin solution impregnated gelatin sponge), was placed in one of
      the sockets.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is a Double-blind, Randomized, Parallel-group, split-mouth.
primary purpose: Treatment
masking: Single (Participant)
masking description: This event was a double-blind study (neither the patients nor the clinicians were aware of the rinsing solution used). Consequently, all periods of treatment, clinical parameters were recorded by an examiner who was blinded to the kind of medication received by the subjects while another clinician gave treatment.
measure: Pain experienced by patients following the atraumatic tooth extraction, evaluated by using a visual analog pain scale within 24 hours.
time frame: one day
description: The pain level is recorded according to the visual analogue scale (VAS) at the intervals of before treatments, also Postoperative analog pain scores were assessed in 30 minutes to 24 hours later.
arm group label: A (Simavastatin 10 mg with gelatin sponge graft)
arm group type: Active Comparator
description: A group: After atraumatic extraction, filled the tooth socket with Simvastatin10 mg solution impregnated gelatin sponge.
arm group label: B(Gelatin sponge graft )
arm group type: Active Comparator
description: B group: Following atraumatic extraction, put in the tooth socket with gelatin sponge.
intervention type: Drug
intervention name: Extraction + filled with Simvastatin solution impregnated gelatin sponge
description: All two first premolars were extracted carefully, have used periotome as a means of atraumatic extraction that facilitated the removal of teeth with minimum damage to the surrounding alveolar bone, teeth to be extracted should have minimum periapical changes radiographically; with decreasing soft tissue reflection; the socket was tan gently irrigated with normal saline and hemostasis was achieved. It must be noted that A group (Extraction + filled with Simvastatin (Poursina Pharmaceutical Co. Tehran-Iran) solution impregnated gelatin sponge (Maquira Industry Dental Products S.A. Brazil) and B group (Extraction + without Simvastatin solution impregnated gelatin sponge), was placed in one of the sockets.
arm group label: A (Simavastatin 10 mg with gelatin sponge graft)
arm group label: B(Gelatin sponge graft )
other name: Extraction + filled gelatin sponge
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Islamic Azad University, Tehran
investigator full name: Amirhossein Farahmand
investigator title: director,clinical research
mesh term: Simvastatin
sharing ipd: No
ipd description: will published