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/NCT05971914</url>
    </required_header>
    <id_info>
      <org_study_id>Cleftgraft-Semmelweis</org_study_id>
      <nct_id>NCT05971914</nct_id>
    </id_info>
    <brief_title>Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft</brief_title>
    <official_title>Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Semmelweis University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Semmelweis 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 present study aims at clinical and radiographic evaluation of the safety and efficacy of&#xD;
        Bonmaker ATB powder combined with a novel split thickness papilla curtain flap in the&#xD;
        treatment of alveolar cleft defects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">October 12, 2021</start_date>
    <completion_date type="Anticipated">August 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">July 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>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Eight patients aged 8-12 years exhibiting uni- or bilateral alveolar cleft defects and oronasal fistulas underwent supra-, subgingival scaling and received individual oral hygiene instructions prior to surgery at the Department of Periodontology, Semmelweis University, Budapest, Hungary. Surgeries will be performed at the I. Department of Paediatrics, Semmelweis University, Budapest, Hungary between January 2021 and November 2021. The study was approved by the Semmelweis University Regional and Institutional Committee of Science and Research Ethics (Approval Number SE TUKEB x/2020). Patients is treated in accordance with the World Medical Association Declaration of Helsinki (version 2008). Surgical interventions are undertaken with the understanding and written consent of each subject's caregiver</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>no masking</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Radiological volumetric measurements</measure>
      <time_frame>6 months</time_frame>
      <description>Volumetric measurements will be conducted after the healing period. On prealigned pre- and postoperative CBCT cross-sections, linear measurements and volumetric measurements will be taken parallel to a reference base to determine the width of the surgical area.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>soft tissue healing</measure>
      <time_frame>during the 6 months postoperatively</time_frame>
      <description>Healing of soft tissues was recorded via photo documentation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>complications</measure>
      <time_frame>1, 14, 30 days and 3 and 6 months after surgeries.</time_frame>
      <description>Every complication will be reported</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">8</enrollment>
    <condition>Cleft Lip and Palate</condition>
    <arm_group>
      <arm_group_label>Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Extracted deciduous teeth were prepared immediately after removal according to the manufacturer's instructions with the Bonmaker® device. Ready to use autogenous tooth bone graft (ATB) was mixed with fibrin glue in 3D planned and printed plastic cuvettes to obtain a sticky graft closely matching the shape and extent of the bony defect. The preshaped sticky ATB graft was inserted and compacted in the cleft defect. Subsequently, the tension-free split thickness flap was repositioned by shifting all buccal surgical papillae mesially to the adjacent or the second adjacent interproximal space, depending on the horizontal extent of the cleft.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap</intervention_name>
      <description>Extracted deciduous teeth were prepared immediately after removal according to the manufacturer's instructions with the Bonmaker® device. Ready to use autogenous tooth bone graft (ATB) was mixed with fibrin glue in 3D planned and printed plastic cuvettes to obtain a sticky graft closely matching the shape and extent of the bony defect. The preshaped sticky ATB graft was inserted and compacted in the cleft defect. Subsequently, the tension-free split thickness flap was repositioned by shifting all buccal surgical papillae mesially to the adjacent or the second adjacent interproximal space, depending on the horizontal extent of the cleft.</description>
      <arm_group_label>Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  children with alveolar cleft&#xD;
  &#xD;
            -  patient presented at least three deciduous teeth scheduled for extraction.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  major relevant clinical diseases,&#xD;
  &#xD;
            -  systemic use of steroids,&#xD;
  &#xD;
            -  current or previous intravenous bisphosphonate treatment,&#xD;
  &#xD;
            -  acute infection at the operation site.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Semmelweis University Department of Periodontology</name>
        <address>
          <city>Budapest</city>
          <zip>1088</zip>
          <country>Hungary</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Hungary</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 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>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Semmelweis University</investigator_affiliation>
      <investigator_full_name>Dr. Nagy Krisztián</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>cleft lip and palate</keyword>
    <keyword>split thickness flap</keyword>
    <keyword>autogenous tooth bone graft</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cleft Lip</mesh_term>
    </condition_browse>
    <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/NCT05971914
  org study id: Cleftgraft-Semmelweis
  nct id: NCT05971914
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The present study aims at clinical and radiographic evaluation of the safety and efficacy of
        Bonmaker ATB powder combined with a novel split thickness papilla curtain flap in the
        treatment of alveolar cleft defects.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Eight patients aged 8-12 years exhibiting uni- or bilateral alveolar cleft defects and oronasal fistulas underwent supra-, subgingival scaling and received individual oral hygiene instructions prior to surgery at the Department of Periodontology, Semmelweis University, Budapest, Hungary. Surgeries will be performed at the I. Department of Paediatrics, Semmelweis University, Budapest, Hungary between January 2021 and November 2021. The study was approved by the Semmelweis University Regional and Institutional Committee of Science and Research Ethics (Approval Number SE TUKEB x/2020). Patients is treated in accordance with the World Medical Association Declaration of Helsinki (version 2008). Surgical interventions are undertaken with the understanding and written consent of each subject's caregiver
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: no masking
  measure: Radiological volumetric measurements
  time frame: 6 months
  description: Volumetric measurements will be conducted after the healing period. On prealigned pre- and postoperative CBCT cross-sections, linear measurements and volumetric measurements will be taken parallel to a reference base to determine the width of the surgical area.
  measure: soft tissue healing
  time frame: during the 6 months postoperatively
  description: Healing of soft tissues was recorded via photo documentation.
  measure: complications
  time frame: 1, 14, 30 days and 3 and 6 months after surgeries.
  description: Every complication will be reported
  arm group label: Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap
  arm group type: Experimental
  description: Extracted deciduous teeth were prepared immediately after removal according to the manufacturer's instructions with the Bonmaker® device. Ready to use autogenous tooth bone graft (ATB) was mixed with fibrin glue in 3D planned and printed plastic cuvettes to obtain a sticky graft closely matching the shape and extent of the bony defect. The preshaped sticky ATB graft was inserted and compacted in the cleft defect. Subsequently, the tension-free split thickness flap was repositioned by shifting all buccal surgical papillae mesially to the adjacent or the second adjacent interproximal space, depending on the horizontal extent of the cleft.
  intervention type: Procedure
  intervention name: Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap
  description: Extracted deciduous teeth were prepared immediately after removal according to the manufacturer's instructions with the Bonmaker® device. Ready to use autogenous tooth bone graft (ATB) was mixed with fibrin glue in 3D planned and printed plastic cuvettes to obtain a sticky graft closely matching the shape and extent of the bony defect. The preshaped sticky ATB graft was inserted and compacted in the cleft defect. Subsequently, the tension-free split thickness flap was repositioned by shifting all buccal surgical papillae mesially to the adjacent or the second adjacent interproximal space, depending on the horizontal extent of the cleft.
  arm group label: Autogenous tooth derived particulate graft and a novel split thickness papilla curtain flap
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 12 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Hungary
  responsible party type: Principal Investigator
  investigator affiliation: Semmelweis University
  investigator full name: Dr. Nagy Krisztián
  investigator title: Associate Professor
  mesh term: Cleft Lip
  sharing ipd: No