xml: <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/NCT06031168</url>
    </required_header>
    <id_info>
      <org_study_id>Implants_2023</org_study_id>
      <nct_id>NCT06031168</nct_id>
    </id_info>
    <brief_title>1% Metformin Gel-coated Implants and Osteointegration and Crestal Marginal Bone Loss</brief_title>
    <official_title>Evaluation the Effect of Topically Coated Dental Implants With 1% Metformin Gel on Osteointegration and Crestal Marginal Bone Loss (a Randomized Controlled Clinical Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hams Hamed Abdelrahman</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Achieving and maintaining a long term osseointegrated dental implant is a golden goal of&#xD;
        success in field of dentistry. Osteointegration depends on surface treatment of dental&#xD;
        implants. various techniques of implant coating have been introduced to enhance and&#xD;
        accelerate osteointegration. The purpose of present study is to clinically and&#xD;
        radiographically evaluate the osseointegration around hydrophilic dental implants coated with&#xD;
        1% Metformin gel Materials and Methods: We executed a randomized controlled clinical trial.&#xD;
        The sample will include patients demanding dental implant treatment. Patients will be&#xD;
        randomly allocated into the two groups of the study. The group A will be treated with 1%&#xD;
        concentrated metformin gel coated hydrophilic dental implant. Group B will be treated with&#xD;
        uncoated hydrophilic dental implant. The primary outcome variable will be implant&#xD;
        osteointegration and crestal marginal bone loss around implants. It will be measured at time&#xD;
        of implant placement and reevaluated after 4, 6-months with periapical x-ray and&#xD;
        3-dimensional imaging.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in implant stability</measure>
      <time_frame>Baseline and 4 months</time_frame>
      <description>stability will be assessed by using ostell device</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>change in marginal bone loss</measure>
      <time_frame>Baseline and 4 months</time_frame>
      <description>To evaluate the amount of bone loss around osseointegrated implants all patient will be subjected to periapical x-ray.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">26</enrollment>
    <condition>Osteointegration</condition>
    <arm_group>
      <arm_group_label>Test group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Metformin gel coated implants</intervention_name>
      <description>Patients will be treated with 1% concentrated metformin gel coated hydrophilic dental implant.</description>
      <arm_group_label>Test group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>uncoated hydrophilic dental implants</intervention_name>
      <description>Patients treated by uncoated implants</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Good general periodontal health and maintenance.&#xD;
  &#xD;
            -  Adequate amount of bone volume at implant site, allowing to perform the dental implant&#xD;
               surgery procedure without bone grafting techniques&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
            -  Heavy smokers who smoke more than ten cigarettes per day&#xD;
  &#xD;
            -  Diabetic patients who have received metformin as antidiabetic drug&#xD;
  &#xD;
            -  local or systemic conditions that will interfere with routine implant placement&#xD;
               (uncontrolled diabetes mellitus or human immune deficiency virus infections, resonance&#xD;
               therapy), bone disorders (hyperparathyroidism, osteoporosis, or Paget's disease&#xD;
  &#xD;
            -  Patients who had subjected to intravenous and/or oral bisphosphonate therapy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mohamed Adel, BDS</last_name>
      <phone>01142212300</phone>
      <email>adelo.free81@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Alexandria Faculty of Dentistry</name>
        <address>
          <city>Alexandria</city>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Mohamed Adel, BDS</last_name>
        <phone>01142212300</phone>
        <email>adelo.free81@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Mohamed Adel, BDS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Alexandria University</investigator_affiliation>
      <investigator_full_name>Hams Hamed Abdelrahman</investigator_full_name>
      <investigator_title>Assistant lecturer of DPH and Clinical statistician</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Metformin</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031168
  org study id: Implants_2023
  nct id: NCT06031168
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Achieving and maintaining a long term osseointegrated dental implant is a golden goal of
        success in field of dentistry. Osteointegration depends on surface treatment of dental
        implants. various techniques of implant coating have been introduced to enhance and
        accelerate osteointegration. The purpose of present study is to clinically and
        radiographically evaluate the osseointegration around hydrophilic dental implants coated with
        1% Metformin gel Materials and Methods: We executed a randomized controlled clinical trial.
        The sample will include patients demanding dental implant treatment. Patients will be
        randomly allocated into the two groups of the study. The group A will be treated with 1%
        concentrated metformin gel coated hydrophilic dental implant. Group B will be treated with
        uncoated hydrophilic dental implant. The primary outcome variable will be implant
        osteointegration and crestal marginal bone loss around implants. It will be measured at time
        of implant placement and reevaluated after 4, 6-months with periapical x-ray and
        3-dimensional imaging.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Change in implant stability
  time frame: Baseline and 4 months
  description: stability will be assessed by using ostell device
  measure: change in marginal bone loss
  time frame: Baseline and 4 months
  description: To evaluate the amount of bone loss around osseointegrated implants all patient will be subjected to periapical x-ray.
  arm group label: Test group
  arm group type: Experimental
  arm group label: Control group
  arm group type: Active Comparator
  intervention type: Other
  intervention name: Metformin gel coated implants
  description: Patients will be treated with 1% concentrated metformin gel coated hydrophilic dental implant.
  arm group label: Test group
  intervention type: Other
  intervention name: uncoated hydrophilic dental implants
  description: Patients treated by uncoated implants
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Mohamed Adel, BDS
  phone: 01142212300
  email: adelo.free81@gmail.com
  facility: 
  contact: 
  investigator: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Alexandria University
  investigator full name: Hams Hamed Abdelrahman
  investigator title: Assistant lecturer of DPH and Clinical statistician
  mesh term: Metformin