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/NCT06027528</url>
    </required_header>
    <id_info>
      <org_study_id>22623</org_study_id>
      <nct_id>NCT06027528</nct_id>
    </id_info>
    <brief_title>Evaluation of Socket Preservation Using Autogenous Dentine Graft With Or Without Autologous Fibrin Glue</brief_title>
    <official_title>Evaluation of Socket Preservation Using Autogenous Dentine Graft With Or Without Autologous Fibrin Glue: A Randomized Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo 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 aim of this interventional study is to investigate the dimensional changes in&#xD;
             buccolingual alveolar ridge width in socket preservation using sticky dentin vs dentin&#xD;
             graft alone&#xD;
  &#xD;
          -  The main question: is dentin graft mixed with autologous fibrin glue has better&#xD;
             dimensional changes than using dentin graft alone ?&#xD;
  &#xD;
          -  outcomes: Change in buccolingual alveolar ridge width as well as apico-coronal alveolar&#xD;
             ridge height&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        -  Aim of the study: The aim of this study is to investigate the dimensional changes in&#xD;
             buccolingual alveolar ridge width. As well as the apico-coronal alveolar ridge height&#xD;
             following tooth extraction when using sticky grafts combined with demineralized dentin&#xD;
             grafts for socket preservation.&#xD;
  &#xD;
          -  Research Procedure in brief:&#xD;
  &#xD;
        This study will be carried out on patients enrolled from the Outpatient Clinic of Oral&#xD;
        Medicine and Periodontology department, Faculty of Dentistry, Cairo University. *operative&#xD;
        procedure: Before tooth extraction, probing depths (PD), gingival recession (GR), and&#xD;
        bleeding on probing (BOP) will be assessed at six sites (mid-facial, mesio-facial,&#xD;
        disto-facial, mid-palatal, mesio-palatal, and disto-palatal) around the tooth to be extracted&#xD;
        and on the adjacent teeth to verify their periodontal status. Local anesthesia will be&#xD;
        administered by infiltration to achieve the necessary anesthesia to allow extraction of the&#xD;
        indicated tooth. Flapless atraumatic extraction will be done. Extracted teeth will be cleaned&#xD;
        from periodontal ligaments, cementum, soft tissue attachment, caries or restorations (if&#xD;
        present), using a high-speed stone. The pulp chamber will be cleaned with sterile endodontic&#xD;
        files. Then, teeth will be grinded to fine particles.&#xD;
  &#xD;
        The particles prepared will be immersed tooth in alcohol for 10 min for disinfection, then&#xD;
        washed twice in saline and dried using sterile gauze.&#xD;
  &#xD;
        Then the dentine graft particles will be prepared by demineralization of tooth particles in&#xD;
        0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and&#xD;
        dried with sterile gauze&#xD;
  &#xD;
        Then the patient will be randomly assigned to one of the treatment groups:&#xD;
  &#xD;
        In group 1 (control group) Demineralized dentine graft will be placed in the socket.&#xD;
  &#xD;
        In group 2 (test group):&#xD;
  &#xD;
        Sticky graft preparation will be done as follows:&#xD;
  &#xD;
          1. Small amount of patient's venous blood (8-10cc) is drawn via venipuncture, and the blood&#xD;
             is placed into non-coated vacutainers to obtain autologous fibrin glue (AFG), which will&#xD;
             make sticky graft.&#xD;
  &#xD;
          2. The blood in the test tubes is centrifuged at 2700-3000 rpm for 2-3 mins.&#xD;
  &#xD;
          3. The upper autologous fibrin glue is obtained with syringe and mixed with particulate of&#xD;
             dentine graft and allows for 5-10 minutes for polymerization in order to produce sticky&#xD;
             graft.&#xD;
  &#xD;
          4. The prepared sticky dentin graft will then be inserted in the socket.&#xD;
  &#xD;
               -  Post operative radiograph:&#xD;
  &#xD;
        Cone beam CT will be taken post surgically to measure the buccolingual dimension in the same&#xD;
        day of the surgery.&#xD;
  &#xD;
        *Post-surgical procedure: (six months after socket preservation) Another Cone beam CT will be&#xD;
        taken to measure the outcomes by superimposition of the 2 CBCT&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in buccolingual alveolar ridge width dimensions immediately after tooth extraction (baseline) and ≥ 6 months after (follow-up).</measure>
      <time_frame>6 month</time_frame>
      <description>superimposition of the 2 CBCT and using Scans which will be exported as DICOM format to 3D viewer software</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>changes in apico-coronal alveolar ridge height immediately after tooth extraction and 6 months after</measure>
      <time_frame>6 months</time_frame>
      <description>superimposition of the 2 CBCT and using Scans which will be exported as DICOM format to 3D viewer software</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Unrestorable Dentition</condition>
    <arm_group>
      <arm_group_label>dentin graft mixed with autologous fibrin glue</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>extracted tooth will be grinded into small particles to form dentin graft that will be mixed with autologous fibrin glue to be grafted in the extracted socket</description>
    </arm_group>
    <arm_group>
      <arm_group_label>dentin graft</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>extracted tooth will be grafted in the extracted socket</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>dentin graft mixed with autologous fibrin glue</intervention_name>
      <description>extracted tooth will be grinded into small particles to form dentin graft that will be mixed with autologous fibrin glue to be grafted in the extracted socket using centrifuge</description>
      <arm_group_label>dentin graft mixed with autologous fibrin glue</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>dentin graft</intervention_name>
      <description>extracted tooth will be grafted in the socket</description>
      <arm_group_label>dentin graft</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Systemically healthy patients ≥18 years old&#xD;
  &#xD;
            -  Nonsmoker&#xD;
  &#xD;
            -  Teeth with root fracture, teeth with failed endodontic therapy or advanced caries&#xD;
  &#xD;
            -  Intact extraction socket with no dehiscence or fenestration.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with systemic diseases.&#xD;
  &#xD;
            -  Patients with dehiscence or fenestrations&#xD;
  &#xD;
            -  Patients with presence or history of osteonecrosis of the jaws, with use of&#xD;
               bisphosphonates, exposure to head and neck radiation, chemotherapy.&#xD;
  &#xD;
            -  Patients with large distinct pre-apical pathology&#xD;
  &#xD;
            -  Smokers of more than 10 cigarettes a day or equivalent to cigarettes&#xD;
  &#xD;
            -  Breastfeeding or pregnant women&#xD;
  &#xD;
            -  Patients without availability to attend follow-up visits or patients rejecting to sign&#xD;
               the informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amr Zahran, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Islam Farag, Bachelor</last_name>
      <phone>01064444052</phone>
      <email>islam.sherif@dentistry.cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Omar Ashour, Ass Lecturer</last_name>
      <email>omar.ashour@dentistry.cu.edu.eg</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 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 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Islam Mohamed Sherif</investigator_full_name>
      <investigator_title>Teaching assistant in periodontology department</investigator_title>
    </responsible_party>
    <keyword>socket preservation</keyword>
    <keyword>alveolar ridge preservation</keyword>
    <keyword>dentin graft</keyword>
    <keyword>autologous fibrin glue</keyword>
    <keyword>sticky dentin</keyword>
    <keyword>sticky graft</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fibrin Tissue Adhesive</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/NCT06027528
  org study id: 22623
  nct id: NCT06027528
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  -  The aim of this interventional study is to investigate the dimensional changes in
             buccolingual alveolar ridge width in socket preservation using sticky dentin vs dentin
             graft alone
  
          -  The main question: is dentin graft mixed with autologous fibrin glue has better
             dimensional changes than using dentin graft alone ?
  
          -  outcomes: Change in buccolingual alveolar ridge width as well as apico-coronal alveolar
             ridge height
  -  Aim of the study: The aim of this study is to investigate the dimensional changes in
             buccolingual alveolar ridge width. As well as the apico-coronal alveolar ridge height
             following tooth extraction when using sticky grafts combined with demineralized dentin
             grafts for socket preservation.
  
          -  Research Procedure in brief:
  
        This study will be carried out on patients enrolled from the Outpatient Clinic of Oral
        Medicine and Periodontology department, Faculty of Dentistry, Cairo University. *operative
        procedure: Before tooth extraction, probing depths (PD), gingival recession (GR), and
        bleeding on probing (BOP) will be assessed at six sites (mid-facial, mesio-facial,
        disto-facial, mid-palatal, mesio-palatal, and disto-palatal) around the tooth to be extracted
        and on the adjacent teeth to verify their periodontal status. Local anesthesia will be
        administered by infiltration to achieve the necessary anesthesia to allow extraction of the
        indicated tooth. Flapless atraumatic extraction will be done. Extracted teeth will be cleaned
        from periodontal ligaments, cementum, soft tissue attachment, caries or restorations (if
        present), using a high-speed stone. The pulp chamber will be cleaned with sterile endodontic
        files. Then, teeth will be grinded to fine particles.
  
        The particles prepared will be immersed tooth in alcohol for 10 min for disinfection, then
        washed twice in saline and dried using sterile gauze.
  
        Then the dentine graft particles will be prepared by demineralization of tooth particles in
        0.6N hydrochloric acid for 30 min to achieve demineralization then washed twice in saline and
        dried with sterile gauze
  
        Then the patient will be randomly assigned to one of the treatment groups:
  
        In group 1 (control group) Demineralized dentine graft will be placed in the socket.
  
        In group 2 (test group):
  
        Sticky graft preparation will be done as follows:
  
          1. Small amount of patient's venous blood (8-10cc) is drawn via venipuncture, and the blood
             is placed into non-coated vacutainers to obtain autologous fibrin glue (AFG), which will
             make sticky graft.
  
          2. The blood in the test tubes is centrifuged at 2700-3000 rpm for 2-3 mins.
  
          3. The upper autologous fibrin glue is obtained with syringe and mixed with particulate of
             dentine graft and allows for 5-10 minutes for polymerization in order to produce sticky
             graft.
  
          4. The prepared sticky dentin graft will then be inserted in the socket.
  
               -  Post operative radiograph:
  
        Cone beam CT will be taken post surgically to measure the buccolingual dimension in the same
        day of the surgery.
  
        *Post-surgical procedure: (six months after socket preservation) Another Cone beam CT will be
        taken to measure the outcomes by superimposition of the 2 CBCT
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Change in buccolingual alveolar ridge width dimensions immediately after tooth extraction (baseline) and ≥ 6 months after (follow-up).
  time frame: 6 month
  description: superimposition of the 2 CBCT and using Scans which will be exported as DICOM format to 3D viewer software
  measure: changes in apico-coronal alveolar ridge height immediately after tooth extraction and 6 months after
  time frame: 6 months
  description: superimposition of the 2 CBCT and using Scans which will be exported as DICOM format to 3D viewer software
  arm group label: dentin graft mixed with autologous fibrin glue
  arm group type: Experimental
  description: extracted tooth will be grinded into small particles to form dentin graft that will be mixed with autologous fibrin glue to be grafted in the extracted socket
  arm group label: dentin graft
  arm group type: Active Comparator
  description: extracted tooth will be grafted in the extracted socket
  intervention type: Procedure
  intervention name: dentin graft mixed with autologous fibrin glue
  description: extracted tooth will be grinded into small particles to form dentin graft that will be mixed with autologous fibrin glue to be grafted in the extracted socket using centrifuge
  arm group label: dentin graft mixed with autologous fibrin glue
  intervention type: Procedure
  intervention name: dentin graft
  description: extracted tooth will be grafted in the socket
  arm group label: dentin graft
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Amr Zahran, Professor
  role: Study Director
  affiliation: Cairo University
  last name: Islam Farag, Bachelor
  phone: 01064444052
  email: islam.sherif@dentistry.cu.edu.eg
  last name: Omar Ashour, Ass Lecturer
  email: omar.ashour@dentistry.cu.edu.eg
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Islam Mohamed Sherif
  investigator title: Teaching assistant in periodontology department
  mesh term: Fibrin Tissue Adhesive