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/NCT06021301</url>
    </required_header>
    <id_info>
      <org_study_id>iPRF and Microneedling</org_study_id>
      <nct_id>NCT06021301</nct_id>
    </id_info>
    <brief_title>Injectable Platelet-Rich Fibrin and Microneedling For Interdental Papillae Reconstruction In Esthetic Zone</brief_title>
    <acronym>iPRFandMN</acronym>
    <official_title>Injectable Platelet-Rich Fibrin and Microneedling For Interdental Papillae Reconstruction In Esthetic Zone (A Case Series )</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo 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>
        The currently available non-surgical techniques for papillary reconstruction did not provide&#xD;
        long term maintenance of papillary regeneration, Surgical techniques are invasive and the&#xD;
        results are unpredictable . The study is based upon the positive effects of iPRF upon&#xD;
        enhancing wound healing in terms of new collagen formation, angiogenesis and increasing&#xD;
        keratinized tissue phenotype . iPRF exhibited comparable effects to subepithelial connective&#xD;
        tissue graft in papillary reconstruction . The effect of microneedling on the tissue responds&#xD;
        as if experiencing tissue trauma and the body's own collagen production is induced to&#xD;
        preserve tissue integrity . Growth factors are released immediately after injury, inducing&#xD;
        the proliferation of new cells, and fibroblasts are transformed into collagen and elastin&#xD;
        fibres from day 5 up to week 8 .&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The patients diagnosed with black triangles according to Norland classification system for&#xD;
        loss of papillary height will be selected. Each patient will receive a proper knowledge of&#xD;
        the study protocols along with full-mouth scaling and root planing (SRP) using ultrasonic and&#xD;
        hand instruments and will be given personalized oral hygiene instructions. After oral&#xD;
        prophylaxis and baseline measurements of insufficient interdental papilla the treatment will&#xD;
        be MN and iPRF. First, MN will be done in the required area with insulin syringe gauge 30,The&#xD;
        interdental papilla will vertically and horizontally measured in mm. By establishing a ratio&#xD;
        and proportion, the number of microchannels in the region to be treated will calculated to be&#xD;
        250 microchannels per square cm. Then, a venous blood sample will be taken for each patient&#xD;
        using a 10-ml injector into i-PRF tube containing no anticoagulant and centrifuged at room&#xD;
        temperature for 3 min at 700 rpm (60 g force). The 30-gauge dental injector needles will be&#xD;
        used for injection of i-PRF. The needle will be inserted at 45° angle, 2-3-mm apical to the&#xD;
        involved papilla and all surrounding areas will receive iPRF. Each involved papilla will be&#xD;
        injected with an amount till blanching is visible . This method will be repeated for 4 times&#xD;
        at 10 days intervals consecutively. The final clinical photographs and measurements will&#xD;
        recorded 3 and 6 months of last dose administered . After the intervention, patients will&#xD;
        receive oral hygiene instructions that include the roll technique when brushing without the&#xD;
        use of floss and toothpick during the study period to minimize trauma to the treated site .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Case Series</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Papillary height</measure>
      <time_frame>at 3,6 months</time_frame>
      <description>using UNC probe from papillary tip till incisal edge.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Injectable Platelet Rich Fibrin and Microneedling in Interdental Papilla Reconstruction</condition>
    <condition>Interdental Papillae Reconstruction</condition>
    <arm_group>
      <arm_group_label>iPRF and Microneedling</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>First, MN will be done in the required area with insulin syringe gauge 30,The interdental papilla will vertically and horizontally measured in mm. By establishing a ratio and proportion, the number of microchannels in the region to be treated will calculated to be 250 microchannels per square cm Then, a venous blood sample will be taken for each patient using a 10-ml injector into i-PRF tube containing no anticoagulant and centrifuged at room temperature for 3 min at 700 rpm (60 g force). The 30-gauge dental injector needles will be used for injection of i-PRF. The needle will be inserted at 45° angle, 2-3-mm apical to the involved papilla and all surrounding areas will receive iPRF. Each involved papilla will be injected with an amount till blanching is visible . This method will be repeated for 4 times at 10 days intervals consecutively.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Platelet-Rich Fibrin and Microneedling</intervention_name>
      <description>First, MN will be done in the required area with insulin syringe gauge 30,The interdental papilla will vertically and horizontally measured in mm. By establishing a ratio and proportion, the number of microchannels in the region to be treated will calculated to be 250 microchannels per square cm Then, a venous blood sample will be taken for each patient using a 10-ml injector into i-PRF tube containing no anticoagulant and centrifuged at room temperature for 3 min at 700 rpm (60 g force). The 30-gauge dental injector needles will be used for injection of i-PRF. The needle will be inserted at 45° angle, 2-3-mm apical to the involved papilla and all surrounding areas will receive iPRF. Each involved papilla will be injected with an amount till blanching is visible . This method will be repeated for 4 times at 10 days intervals consecutively.</description>
      <arm_group_label>iPRF and Microneedling</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Nonsmoking patients aged above 18 years.&#xD;
  &#xD;
            -  At least one site with interdental papilla recession in the anterior region of the&#xD;
               maxillary or mandibular jaws.&#xD;
  &#xD;
            -  The distance from the contact point to alveolar bone is crest &lt; 7 mm.&#xD;
  &#xD;
            -  Class I or Class II papillary recession, according to Nordland and Tarnow's&#xD;
               classification systems (Nordland et al., 1998).&#xD;
  &#xD;
            -  No active periodontal diseases and good oral hygiene.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients were excluded from the study if they have:&#xD;
  &#xD;
            -  Spacing or crowding between the teeth to be treated&#xD;
  &#xD;
            -  Abnormal tooth shape&#xD;
  &#xD;
            -  Systemic diseases such as diabetes mellitus, hypertension or conditions that alter the&#xD;
               outcome of periodontal therapy.&#xD;
  &#xD;
            -  In addition, patients will be excluded if they are Pregnant and lactating women.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>yasmeen tolba, Resident</last_name>
      <role>Principal Investigator</role>
      <affiliation>department of periodontology ,cairo university</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>yasmeen tolba, Resident</last_name>
      <phone>01027453609</phone>
      <email>yasmeen.tolba@dentistry.cu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of Dentistry ,Cairo University</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>yasmeen saleh, Resident</last_name>
        <phone>01027453609</phone>
        <email>yasmeen.tolba@dentistry.cu.edu.egyas</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Yasmeen Saleh Tolba</investigator_full_name>
      <investigator_title>Resident at Faculty of Oral and Dental medicine, Cairo University.</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06021301
  org study id: iPRF and Microneedling
  nct id: NCT06021301
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The currently available non-surgical techniques for papillary reconstruction did not provide
        long term maintenance of papillary regeneration, Surgical techniques are invasive and the
        results are unpredictable . The study is based upon the positive effects of iPRF upon
        enhancing wound healing in terms of new collagen formation, angiogenesis and increasing
        keratinized tissue phenotype . iPRF exhibited comparable effects to subepithelial connective
        tissue graft in papillary reconstruction . The effect of microneedling on the tissue responds
        as if experiencing tissue trauma and the body's own collagen production is induced to
        preserve tissue integrity . Growth factors are released immediately after injury, inducing
        the proliferation of new cells, and fibroblasts are transformed into collagen and elastin
        fibres from day 5 up to week 8 .
  The patients diagnosed with black triangles according to Norland classification system for
        loss of papillary height will be selected. Each patient will receive a proper knowledge of
        the study protocols along with full-mouth scaling and root planing (SRP) using ultrasonic and
        hand instruments and will be given personalized oral hygiene instructions. After oral
        prophylaxis and baseline measurements of insufficient interdental papilla the treatment will
        be MN and iPRF. First, MN will be done in the required area with insulin syringe gauge 30,The
        interdental papilla will vertically and horizontally measured in mm. By establishing a ratio
        and proportion, the number of microchannels in the region to be treated will calculated to be
        250 microchannels per square cm. Then, a venous blood sample will be taken for each patient
        using a 10-ml injector into i-PRF tube containing no anticoagulant and centrifuged at room
        temperature for 3 min at 700 rpm (60 g force). The 30-gauge dental injector needles will be
        used for injection of i-PRF. The needle will be inserted at 45° angle, 2-3-mm apical to the
        involved papilla and all surrounding areas will receive iPRF. Each involved papilla will be
        injected with an amount till blanching is visible . This method will be repeated for 4 times
        at 10 days intervals consecutively. The final clinical photographs and measurements will
        recorded 3 and 6 months of last dose administered . After the intervention, patients will
        receive oral hygiene instructions that include the roll technique when brushing without the
        use of floss and toothpick during the study period to minimize trauma to the treated site .
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Case Series
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Papillary height
  time frame: at 3,6 months
  description: using UNC probe from papillary tip till incisal edge.
  arm group label: iPRF and Microneedling
  arm group type: Experimental
  description: First, MN will be done in the required area with insulin syringe gauge 30,The interdental papilla will vertically and horizontally measured in mm. By establishing a ratio and proportion, the number of microchannels in the region to be treated will calculated to be 250 microchannels per square cm Then, a venous blood sample will be taken for each patient using a 10-ml injector into i-PRF tube containing no anticoagulant and centrifuged at room temperature for 3 min at 700 rpm (60 g force). The 30-gauge dental injector needles will be used for injection of i-PRF. The needle will be inserted at 45° angle, 2-3-mm apical to the involved papilla and all surrounding areas will receive iPRF. Each involved papilla will be injected with an amount till blanching is visible . This method will be repeated for 4 times at 10 days intervals consecutively.
  intervention type: Other
  intervention name: Platelet-Rich Fibrin and Microneedling
  description: First, MN will be done in the required area with insulin syringe gauge 30,The interdental papilla will vertically and horizontally measured in mm. By establishing a ratio and proportion, the number of microchannels in the region to be treated will calculated to be 250 microchannels per square cm Then, a venous blood sample will be taken for each patient using a 10-ml injector into i-PRF tube containing no anticoagulant and centrifuged at room temperature for 3 min at 700 rpm (60 g force). The 30-gauge dental injector needles will be used for injection of i-PRF. The needle will be inserted at 45° angle, 2-3-mm apical to the involved papilla and all surrounding areas will receive iPRF. Each involved papilla will be injected with an amount till blanching is visible . This method will be repeated for 4 times at 10 days intervals consecutively.
  arm group label: iPRF and Microneedling
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: yasmeen tolba, Resident
  role: Principal Investigator
  affiliation: department of periodontology ,cairo university
  last name: yasmeen tolba, Resident
  phone: 01027453609
  email: yasmeen.tolba@dentistry.cu.edu.eg
  facility: 
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Yasmeen Saleh Tolba
  investigator title: Resident at Faculty of Oral and Dental medicine, Cairo University.
  sharing ipd: No