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/NCT06037070</url>
    </required_header>
    <id_info>
      <org_study_id>MUOSU-202104</org_study_id>
      <nct_id>NCT06037070</nct_id>
    </id_info>
    <brief_title>Impact of Biological Factors on Dental Implant</brief_title>
    <official_title>Impact of Biological Factors on Dental Implant Osseointegration</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Mustansiriyah University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Al-Mustansiriyah University</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this randomized controlled trial is to compare the response of different bone&#xD;
        densities to treatment with Platelet Rich Fibrin (PRF) in patients who need treatment with&#xD;
        dental implant.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  To investigate if bone reaction to PRF differ with different bone densities.&#xD;
  &#xD;
          -  To study the effect of PRF on dental implant healing and to assess its effectiveness in&#xD;
             accelerating osseointegration.&#xD;
  &#xD;
        Participants who need treatment with dental implant will be planned to include in this study&#xD;
        and will be asked if they are willing to participate in this study voluntarily.&#xD;
  &#xD;
        All the participants will be given an information sheet and a consent form which provides&#xD;
        simple description about the present study and its importance to insure voluntary&#xD;
        participation. The patients will be aware that they are completely free to withdraw from the&#xD;
        research any time during the research time.&#xD;
  &#xD;
        Platelet Rich Fibrin will be injected inside the hole that prepared to place dental implant&#xD;
        in. Bone density will be evaluated, degree of osseointegration will be monitored.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Materials and methods:&#xD;
  &#xD;
        Two implants will be implanted at the same time, one will have PRF that will be injected&#xD;
        inside the hole that prepared to place dental implant in [PRF is obtained from a blood sample&#xD;
        is taken from the patient at the time of surgery in 10-mL tubes, the blood-containing tube is&#xD;
        placed in a centrifuge at specially controlled rotations, temperature and time]. The other&#xD;
        implant will not receive any treatment (the control one).&#xD;
  &#xD;
        Evaluation of the results&#xD;
  &#xD;
          -  Evaluation of bone density in implant site will be determined using CBCT [ the same CBCT&#xD;
             that have been used for planning dental implant treatment].&#xD;
  &#xD;
             ***[In dental implant treatment it is mandatory to perform CBCT for each patient, to&#xD;
             ensure the accuracy of dental implant size and position, and to ensure there will be no&#xD;
             damage to any vital structure during surgery (e.g. inferior dental nerve, maxillary&#xD;
             sinus, …etc)].&#xD;
  &#xD;
          -  Evaluation of the degree of osseointegration will be performed using Osstell devise.&#xD;
             [Osstell is a tool uses Resonance Frequency Analysis (RFA) that measures the frequency&#xD;
             with which a device vibrates]. Measurement will be conducted at implant placement for a&#xD;
             baseline reading and after 2weeks, 4weeks, 8 weeks, 10 weeks, 12 weeks.&#xD;
  &#xD;
          -  Evaluate pain by visual analogue score (VAS).&#xD;
  &#xD;
          -  Estimate of the complete blood picture, vit D, Ca and K will obtained from laboratory&#xD;
             results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2024</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>Split-mouth trials</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>osseointegration</measure>
      <time_frame>Immediately after surgery, after two weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks</time_frame>
      <description>Evaluation of the changes in the degree of osseointegration will be performed using Osstell devise.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bone density</measure>
      <time_frame>before surgery, with the treatment plan preparation</time_frame>
      <description>Determined using CBCT</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Dental Implant</condition>
    <arm_group>
      <arm_group_label>group with PRF</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>PRF placed inside the hole that prepared to place dental implant</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>with out and additive</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Platelet Rich Fibrin</intervention_name>
      <description>PRF will be injected inside the hole that prepared to place dental implant</description>
      <arm_group_label>group with PRF</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
            -  Non- smoker.&#xD;
  &#xD;
            -  No medical history of any systemic diseases that affect the bone metabolism.&#xD;
  &#xD;
            -  Did not receive any systemic drugs.&#xD;
  &#xD;
            -  Has edentulous area that needs at least two successive implants.&#xD;
  &#xD;
          The exclusion criteria were as follows:&#xD;
  &#xD;
            -  Systemic disease or medication compromising bone and soft tissue healing.&#xD;
  &#xD;
            -  Pathology in the edentulous region.&#xD;
  &#xD;
            -  Bruxism.&#xD;
  &#xD;
            -  Disease of the oral mucosa.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Afya SD Al-radha, Ph. D</last_name>
      <role>Principal Investigator</role>
      <affiliation>College of Dentistry / Mustansiriyah University, P.O. Box: 14022,Baghdad, Iraq</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Assis. Prof. Dr. Afya SD Al-Radha, Ph.D</last_name>
      <phone>07816883387</phone>
      <phone_ext>00964</phone_ext>
      <email>drafya_diab@uomustansiriyah.edu.iq</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Afya SD Al-radha, Ph.D</last_name>
      <phone>07816883387</phone>
      <phone_ext>00964</phone_ext>
      <email>drafya_diab@uomustansiriyah.edu.iq</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kadhimiya Teaching HospitalKadhimiya Educational Hospital</name>
        <address>
          <city>Baghdad</city>
          <state>Alkadhmiya City</state>
          <zip>60 St</zip>
          <country>Iraq</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iraq</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>November 22, 2022</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Al-Mustansiriyah University</investigator_affiliation>
      <investigator_full_name>Afya Sahib Diab Al-radha</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Dental implants</keyword>
    <keyword>PRF</keyword>
    <keyword>CBCT</keyword>
    <keyword>osseointegration</keyword>
    <keyword>bone density</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>all IPD that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>after publication of the research, No end date.</ipd_time_frame>
      <ipd_access_criteria>Anyone who wishes to access the data.</ipd_access_criteria>
      <ipd_url>http://myaccount.google.com/?utm_source=OGB&amp;utm_medium=app&amp;pli=1</ipd_url>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>September 6, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT06037070/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06037070
  org study id: MUOSU-202104
  nct id: NCT06037070
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized controlled trial is to compare the response of different bone
        densities to treatment with Platelet Rich Fibrin (PRF) in patients who need treatment with
        dental implant.
  
        The main questions it aims to answer are:
  
          -  To investigate if bone reaction to PRF differ with different bone densities.
  
          -  To study the effect of PRF on dental implant healing and to assess its effectiveness in
             accelerating osseointegration.
  
        Participants who need treatment with dental implant will be planned to include in this study
        and will be asked if they are willing to participate in this study voluntarily.
  
        All the participants will be given an information sheet and a consent form which provides
        simple description about the present study and its importance to insure voluntary
        participation. The patients will be aware that they are completely free to withdraw from the
        research any time during the research time.
  
        Platelet Rich Fibrin will be injected inside the hole that prepared to place dental implant
        in. Bone density will be evaluated, degree of osseointegration will be monitored.
  Materials and methods:
  
        Two implants will be implanted at the same time, one will have PRF that will be injected
        inside the hole that prepared to place dental implant in [PRF is obtained from a blood sample
        is taken from the patient at the time of surgery in 10-mL tubes, the blood-containing tube is
        placed in a centrifuge at specially controlled rotations, temperature and time]. The other
        implant will not receive any treatment (the control one).
  
        Evaluation of the results
  
          -  Evaluation of bone density in implant site will be determined using CBCT [ the same CBCT
             that have been used for planning dental implant treatment].
  
             ***[In dental implant treatment it is mandatory to perform CBCT for each patient, to
             ensure the accuracy of dental implant size and position, and to ensure there will be no
             damage to any vital structure during surgery (e.g. inferior dental nerve, maxillary
             sinus, …etc)].
  
          -  Evaluation of the degree of osseointegration will be performed using Osstell devise.
             [Osstell is a tool uses Resonance Frequency Analysis (RFA) that measures the frequency
             with which a device vibrates]. Measurement will be conducted at implant placement for a
             baseline reading and after 2weeks, 4weeks, 8 weeks, 10 weeks, 12 weeks.
  
          -  Evaluate pain by visual analogue score (VAS).
  
          -  Estimate of the complete blood picture, vit D, Ca and K will obtained from laboratory
             results.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Split-mouth trials
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: osseointegration
  time frame: Immediately after surgery, after two weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks
  description: Evaluation of the changes in the degree of osseointegration will be performed using Osstell devise.
  measure: Bone density
  time frame: before surgery, with the treatment plan preparation
  description: Determined using CBCT
  arm group label: group with PRF
  arm group type: Experimental
  description: PRF placed inside the hole that prepared to place dental implant
  arm group label: control group
  arm group type: No Intervention
  description: with out and additive
  intervention type: Biological
  intervention name: Platelet Rich Fibrin
  description: PRF will be injected inside the hole that prepared to place dental implant
  arm group label: group with PRF
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Afya SD Al-radha, Ph. D
  role: Principal Investigator
  affiliation: College of Dentistry / Mustansiriyah University, P.O. Box: 14022,Baghdad, Iraq
  last name: Assis. Prof. Dr. Afya SD Al-Radha, Ph.D
  phone: 07816883387
  phone ext: 00964
  email: drafya_diab@uomustansiriyah.edu.iq
  last name: Afya SD Al-radha, Ph.D
  phone: 07816883387
  phone ext: 00964
  email: drafya_diab@uomustansiriyah.edu.iq
  facility: 
  country: Iraq
  responsible party type: Principal Investigator
  investigator affiliation: Al-Mustansiriyah University
  investigator full name: Afya Sahib Diab Al-radha
  investigator title: Assistant Professor
  sharing ipd: Yes
  ipd description: all IPD that underlie results in a publication
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: after publication of the research, No end date.
  ipd access criteria: Anyone who wishes to access the data.
  ipd url: http://myaccount.google.com/?utm_source=OGB&utm_medium=app&pli=1
  provided document: 