<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/NCT03269214</url>
  </required_header>
  <id_info>
    <org_study_id>1396D22</org_study_id>
    <nct_id>NCT03269214</nct_id>
  </id_info>
  <brief_title>Use of Topical Phenytoin in Bisphosphonate-related Osteonecrosis of the Mandible</brief_title>
  <official_title>Does Topical Phenytoin Enhance Healing Process in Bisphosphonate-related Osteonecrosis of the Mandible. A Uni-blind Clinical Trial Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shiraz University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shahid Beheshti University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shiraz University of Medical Sciences</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients who had bisphosphonate-related osteonecrosis of the jaw in stage II were allocated&#xD;
      in two groups randomly : In group1, 10 patients underwent debridement and primary closer of&#xD;
      the area,in group 2 , patients received Phenytoin + tetracycline topically in the debridement&#xD;
      area.Wound dehiscence , infection and pain were in 1,6 and 12 months after treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients undergo surgical necrotic bone debridement in combination with antibiotic&#xD;
      therapy (clindamycin 300 mg q8h) for 4 weeks . Patients who had BRON of the mandible randomly&#xD;
      allocated in 2 groups. Group 1 underwent debridement of necrotic bone and the involved area&#xD;
      closed primary and in group 2 ,patients received topical Phenytoin 5%+ Tetracycline. Patients&#xD;
      were evaluated after 1(time1) ,6(time2) and 12(time 3) months.&#xD;
&#xD;
      The size of bone lesion was measured by using come beam computer tomography (CBCT).&#xD;
&#xD;
      Wound dehiscence (Stage 0 :No dehiscence ,Stage 1: less than 10 mm dehiscence,stage 2 : more&#xD;
      than 10 mm dehiscence) Infection: Pus, sinus tract (Yes/NO) Pain according to visual analog&#xD;
      scale (VAS) 0-10.In the third follow up time ( 12 months) ,the number of patients who were a&#xD;
      time span of 3 months without clinical symptoms were documented in each group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2012</start_date>
  <completion_date type="Actual">March 30, 2017</completion_date>
  <primary_completion_date type="Actual">October 31, 2016</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients who had bisphosphonate-related osteonecrosis of the jaw of the mandible randomly allocated in 2 groups. Group 1 underwent debridement of necrotic bone and the involved area closed primary and in group 2 ,patients received topical Phenytoin 5%+ Tetracycline</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Neither patients nor investigators were unaware about treatment and control groups.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Soft tissue healing</measure>
    <time_frame>After one month</time_frame>
    <description>Appropriate soft tissue healing was defined when no dehiscence occurred</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Soft tissue healing</measure>
    <time_frame>Six months after treatment</time_frame>
    <description>Appropriate soft tissue healing was defined when no dehiscence occurred</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Soft tissue healing</measure>
    <time_frame>12 months after treatment</time_frame>
    <description>Appropriate soft tissue healing was defined when no dehiscence occurred</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>one month after treatment</time_frame>
    <description>Based on visual analogue scale 0-10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>Six months after treatment</time_frame>
    <description>Based on visual analogue scale 0-10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infection</measure>
    <time_frame>One month after treatment</time_frame>
    <description>Any sign of pus or fistula tract in treatment area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection</measure>
    <time_frame>Six months after treatment</time_frame>
    <description>Any sign of pus or fistula tract in treatment area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection</measure>
    <time_frame>12 months after treatment</time_frame>
    <description>Any sign of pus or fistula tract in treatment area</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Osteonecrosis Due to Drugs, Jaw</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients underwent debridement of necrotic bone and the involved area closed primary</description>
  </arm_group>
  <arm_group>
    <arm_group_label>treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received topical Phenytoin 5%+ Tetracycline after debridement before final closure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical Phenytoin 5%</intervention_name>
    <description>Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .</description>
    <arm_group_label>treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Criteria of bisphosphonate-related Osteonecrosis in stage II&#xD;
&#xD;
          -  need debridement and surgical intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Malignancy in the area&#xD;
&#xD;
          -  History of chemotherapy ,&#xD;
&#xD;
          -  diabetic mellitus&#xD;
&#xD;
          -  HIV&#xD;
&#xD;
          -  odontogenic infection or undergo dialysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shiraz University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Reza Tabrizi</investigator_full_name>
    <investigator_title>associate professor of oral and maxillofacial surgery</investigator_title>
  </responsible_party>
  <keyword>osteonecrosis</keyword>
  <keyword>mandible</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteonecrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenytoin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We realize final results without any information about individuals who attended in this study</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/NCT03269214
org study id: 1396D22
nct id: NCT03269214
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients who had bisphosphonate-related osteonecrosis of the jaw in stage II were allocated
      in two groups randomly : In group1, 10 patients underwent debridement and primary closer of
      the area,in group 2 , patients received Phenytoin + tetracycline topically in the debridement
      area.Wound dehiscence , infection and pain were in 1,6 and 12 months after treatment.
All patients undergo surgical necrotic bone debridement in combination with antibiotic
      therapy (clindamycin 300 mg q8h) for 4 weeks . Patients who had BRON of the mandible randomly
      allocated in 2 groups. Group 1 underwent debridement of necrotic bone and the involved area
      closed primary and in group 2 ,patients received topical Phenytoin 5%+ Tetracycline. Patients
      were evaluated after 1(time1) ,6(time2) and 12(time 3) months.

      The size of bone lesion was measured by using come beam computer tomography (CBCT).

      Wound dehiscence (Stage 0 :No dehiscence ,Stage 1: less than 10 mm dehiscence,stage 2 : more
      than 10 mm dehiscence) Infection: Pus, sinus tract (Yes/NO) Pain according to visual analog
      scale (VAS) 0-10.In the third follow up time ( 12 months) ,the number of patients who were a
      time span of 3 months without clinical symptoms were documented in each group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients who had bisphosphonate-related osteonecrosis of the jaw of the mandible randomly allocated in 2 groups. Group 1 underwent debridement of necrotic bone and the involved area closed primary and in group 2 ,patients received topical Phenytoin 5%+ Tetracycline
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Neither patients nor investigators were unaware about treatment and control groups.
measure: Soft tissue healing
time frame: After one month
description: Appropriate soft tissue healing was defined when no dehiscence occurred
measure: Soft tissue healing
time frame: Six months after treatment
description: Appropriate soft tissue healing was defined when no dehiscence occurred
measure: Soft tissue healing
time frame: 12 months after treatment
description: Appropriate soft tissue healing was defined when no dehiscence occurred
measure: Pain
time frame: one month after treatment
description: Based on visual analogue scale 0-10
measure: Pain
time frame: Six months after treatment
description: Based on visual analogue scale 0-10
measure: Infection
time frame: One month after treatment
description: Any sign of pus or fistula tract in treatment area
measure: Infection
time frame: Six months after treatment
description: Any sign of pus or fistula tract in treatment area
measure: Infection
time frame: 12 months after treatment
description: Any sign of pus or fistula tract in treatment area
arm group label: control group
arm group type: No Intervention
description: Patients underwent debridement of necrotic bone and the involved area closed primary
arm group label: treatment group
arm group type: Experimental
description: Patients received topical Phenytoin 5%+ Tetracycline after debridement before final closure.
intervention type: Drug
intervention name: Topical Phenytoin 5%
description: Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .
arm group label: treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Shiraz University of Medical Sciences
investigator full name: Reza Tabrizi
investigator title: associate professor of oral and maxillofacial surgery
mesh term: Osteonecrosis
mesh term: Phenytoin
sharing ipd: No
ipd description: We realize final results without any information about individuals who attended in this study