<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/NCT01680042</url>
  </required_header>
  <id_info>
    <org_study_id>Merck-023</org_study_id>
    <nct_id>NCT01680042</nct_id>
  </id_info>
  <brief_title>Clinical Effect of Phenytoin Mucoadhesive Paste on Wound Healing After Oral Biopsy</brief_title>
  <official_title>Phase 1 Study of Phenytoin Mucoadhesive Paste for Wound Healing After Oral Biopsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shahid Beheshti University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shahid Beheshti University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      several studies have investigated healing effect of phenytoin.In this study we investigate&#xD;
      healing effect of phenytoin mucoadhesive paste comparing to the usual mucoadhesive paste&#xD;
      after oral biopsy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Anticipated">March 2013</primary_completion_date>
  <phase>Phase 1</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>healing biopsy wound</measure>
    <time_frame>7 days</time_frame>
    <description>patient recieves phenytoin mucoadhesive paste after oral biopsy and the diameter of inflammatory halo is determined in 1,3,5and the 7th days.pain measurment is also assesed by VAS score</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Wound Healing</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>phenytoin paste</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>this group receives phenytoin paste after oral biopsy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual mucoadhesive paste</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>this group receives the usual mucoadhesive paste without phenytoin after oral biopsy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phenytoin paste</intervention_name>
    <arm_group_label>phenytoin paste</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>usual mucoadhesive paste</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergone oral biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>somayeh alirezaei, DDS</last_name>
    <phone>09123705943</phone>
    <email>dr.somayehalirezaei@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shaheed Beheshti University</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>somayeh alirezaei, resident</last_name>
      <phone>09190129151</phone>
      <email>somayeh_alirezaei_dentist@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>somayeh alirezaei, resident</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shahid Beheshti Medical University</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>somayeh alirezaei, DDS</last_name>
      <phone>09123705943</phone>
      <email>dr.somayehalirezaei@gmail.com</email>
    </contact>
    <investigator>
      <last_name>somayeh alirezaei, DDS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>October 1, 2012</last_update_submitted>
  <last_update_submitted_qc>October 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Beheshti University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>somayeh alirezaei</investigator_full_name>
    <investigator_title>resident</investigator_title>
  </responsible_party>
  <keyword>inflammatory halo</keyword>
  <keyword>VAS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenytoin</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/NCT01680042
org study id: Merck-023
nct id: NCT01680042
lead sponsor: 
has dmc: Yes
several studies have investigated healing effect of phenytoin.In this study we investigate
      healing effect of phenytoin mucoadhesive paste comparing to the usual mucoadhesive paste
      after oral biopsy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: healing biopsy wound
time frame: 7 days
description: patient recieves phenytoin mucoadhesive paste after oral biopsy and the diameter of inflammatory halo is determined in 1,3,5and the 7th days.pain measurment is also assesed by VAS score
arm group label: phenytoin paste
arm group type: Active Comparator
description: this group receives phenytoin paste after oral biopsy
arm group label: usual mucoadhesive paste
arm group type: Placebo Comparator
description: this group receives the usual mucoadhesive paste without phenytoin after oral biopsy
intervention type: Drug
intervention name: Phenytoin paste
arm group label: phenytoin paste
intervention type: Drug
intervention name: Placebo
arm group label: usual mucoadhesive paste
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: somayeh alirezaei, DDS
phone: 09123705943
email: dr.somayehalirezaei@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Shahid Beheshti University of Medical Sciences
investigator full name: somayeh alirezaei
investigator title: resident
mesh term: Wounds and Injuries
mesh term: Phenytoin