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/NCT05971342</url>
    </required_header>
    <id_info>
      <org_study_id>Mao Xue Li</org_study_id>
      <nct_id>NCT05971342</nct_id>
    </id_info>
    <brief_title>The Safety and Efficacy of Alveolar Bone Defect Repair Induced by Gelatin Sponge-loaded Apoptotic Vesicle Complex</brief_title>
    <official_title>A Two-arm Clinical Study to Evaluate the Safety and Efficacy of Gelatin Sponge-loaded Apoptotic Vesicle Complex for Alveolar Bone Defect Repair After Mandibular Third Molar Extraction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fifth Affiliated Hospital of Guangzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fifth Affiliated Hospital of Guangzhou Medical 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>
        Distal bone loss of the second molar due to extraction of the third molar is one of the most&#xD;
        common pathological conditions that results in tooth loss of second molar. However,&#xD;
        regeneration of functional alveolar bone has proved difficult. Therefore, the investigators&#xD;
        conduct a two-arm study to evaluate the efficacy and safety of alveolar bone regeneration&#xD;
        induced by gelatin sponge-loaded apoptotic vesicle complex in patients with mandibular third&#xD;
        molar extraction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a single-center, prospective, two-arm study to evaluate the efficacy and safety&#xD;
        of alveolar bone regeneration induced by gelatin sponge-loaded apoptotic vesicle complex in&#xD;
        patients with mandibular third molar extraction. This study plans to include 30 subjects from&#xD;
        the Department of Stomatology of the Fifth Affiliated Hospital of Guangzhou Medical&#xD;
        University. One socket for each participant in this study will receive gelatin sponge-loaded&#xD;
        apoptotic vesicle complex after third molar extraction and socket debridement. The other side&#xD;
        of socket for each participant in this study will receive commercial gelatin sponge after the&#xD;
        same surgery. All participants will undergo screening and baseline visits. After surgery, the&#xD;
        participants will be followed up for 1 year.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Bone volume fraction of regenerated bone tissue in the extraction area at 3 months after operation</measure>
      <time_frame>3 months</time_frame>
      <description>CBCT is a cone-beam projection computerized reconstruction tomography device. Its principle is that the X-ray generator uses a low radiation dose to make a circular DR (digital projection) around the projection body. Then the data obtained in the &quot;intersection&quot; after digital projection around the projection body multiple times is &quot;reconstructed&quot; in the computer to obtain a three-dimensional image. CBCT can observe the three-dimensional level of bone regeneration, so as to calculate the bone volume fraction of the regenerated bone tissue.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hemostatic time after third molar extraction</measure>
      <time_frame>0 day</time_frame>
      <description>After the third molar was completely extracted, commercial gelatin sponge or gelatin sponge loaded with apoptotic vesicle complex were placed in the socket. The time to hemostasis in the extraction socket was observed and recorded at the same time.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Third Molar Extraction</condition>
    <arm_group>
      <arm_group_label>Gelatin sponge-loaded apoptotic vesicle complex</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>4 * 10^10 apoptotic vesicles derived from umbilical cord mesenchymal stem cells were loaded in a gelatin sponge（Kuaikang®）. A piece of gelatin sponge-loaded apoptotic vesicle complex was placed in an extraction socket after tooth extraction.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Gelatin sponge only</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>A piece of gelatin sponge（Kuaikang®）was placed in an extraction socket after tooth extraction.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®)</intervention_name>
      <description>The experimental group</description>
      <arm_group_label>Gelatin sponge-loaded apoptotic vesicle complex</arm_group_label>
      <other_name>Gelatin sponge （Kuaikang®）. Apoptotic vesicles are derived from umbilical cord mesenchymal stem cells</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gelatin sponge only （Kuaikang®)</intervention_name>
      <description>The positive control group</description>
      <arm_group_label>Gelatin sponge only</arm_group_label>
      <other_name>Gelatin sponge （Kuaikang®）</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients aged 18-45 (including the boundary value)&#xD;
  &#xD;
            2. Patients who need to extract the bilateral mandible third molars&#xD;
  &#xD;
            3. Patients who voluntarily sign the informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The adjacent second molars in the patient's oral cavity are affected by pulp injury or&#xD;
               insufficient endodontic treatment, or show tooth fracture, or have a degree of motion&#xD;
               of 3 degrees&#xD;
  &#xD;
            2. The adjacent second molars have metal crowns or large amalgam restorations&#xD;
  &#xD;
            3. There is an uncontrollable pathological process in the patient's oral cavity&#xD;
  &#xD;
            4. Malnutrition (serum albumin concentration &lt;2 g/dl)&#xD;
  &#xD;
            5. Other systemic, infectious diseases and hereditary diseases, or patients in the acute&#xD;
               inflammatory phase and acute exacerbation phase of chronic diseases&#xD;
  &#xD;
            6. Patients who are pregnant, lactating, or planning to become pregnant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Third Molar Extraction</keyword>
    <keyword>Alveolar Bone Regeneration</keyword>
    <!-- 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/NCT05971342
  org study id: Mao Xue Li
  nct id: NCT05971342
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Distal bone loss of the second molar due to extraction of the third molar is one of the most
        common pathological conditions that results in tooth loss of second molar. However,
        regeneration of functional alveolar bone has proved difficult. Therefore, the investigators
        conduct a two-arm study to evaluate the efficacy and safety of alveolar bone regeneration
        induced by gelatin sponge-loaded apoptotic vesicle complex in patients with mandibular third
        molar extraction.
  This study is a single-center, prospective, two-arm study to evaluate the efficacy and safety
        of alveolar bone regeneration induced by gelatin sponge-loaded apoptotic vesicle complex in
        patients with mandibular third molar extraction. This study plans to include 30 subjects from
        the Department of Stomatology of the Fifth Affiliated Hospital of Guangzhou Medical
        University. One socket for each participant in this study will receive gelatin sponge-loaded
        apoptotic vesicle complex after third molar extraction and socket debridement. The other side
        of socket for each participant in this study will receive commercial gelatin sponge after the
        same surgery. All participants will undergo screening and baseline visits. After surgery, the
        participants will be followed up for 1 year.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Bone volume fraction of regenerated bone tissue in the extraction area at 3 months after operation
  time frame: 3 months
  description: CBCT is a cone-beam projection computerized reconstruction tomography device. Its principle is that the X-ray generator uses a low radiation dose to make a circular DR (digital projection) around the projection body. Then the data obtained in the "intersection" after digital projection around the projection body multiple times is "reconstructed" in the computer to obtain a three-dimensional image. CBCT can observe the three-dimensional level of bone regeneration, so as to calculate the bone volume fraction of the regenerated bone tissue.
  measure: Hemostatic time after third molar extraction
  time frame: 0 day
  description: After the third molar was completely extracted, commercial gelatin sponge or gelatin sponge loaded with apoptotic vesicle complex were placed in the socket. The time to hemostasis in the extraction socket was observed and recorded at the same time.
  arm group label: Gelatin sponge-loaded apoptotic vesicle complex
  arm group type: Experimental
  description: 4 * 10^10 apoptotic vesicles derived from umbilical cord mesenchymal stem cells were loaded in a gelatin sponge（Kuaikang®）. A piece of gelatin sponge-loaded apoptotic vesicle complex was placed in an extraction socket after tooth extraction.
  arm group label: Gelatin sponge only
  arm group type: Active Comparator
  description: A piece of gelatin sponge（Kuaikang®）was placed in an extraction socket after tooth extraction.
  intervention type: Drug
  intervention name: Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®)
  description: The experimental group
  arm group label: Gelatin sponge-loaded apoptotic vesicle complex
  other name: Gelatin sponge （Kuaikang®）. Apoptotic vesicles are derived from umbilical cord mesenchymal stem cells
  intervention type: Drug
  intervention name: Gelatin sponge only （Kuaikang®)
  description: The positive control group
  arm group label: Gelatin sponge only
  other name: Gelatin sponge （Kuaikang®）
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor