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/NCT06016894</url>
    </required_header>
    <id_info>
      <org_study_id>khafrelsheikh university</org_study_id>
      <nct_id>NCT06016894</nct_id>
    </id_info>
    <brief_title>Hydroxyapetite Nanoparticles, Tricalcium Phosphate Nanoparticles, and PRF for Treatment of Gingival Recession</brief_title>
    <official_title>Comparative Study Between Hydroxyapetite Nanoparticles and Tricalcium Phosphate Nanoparticles Loaded on Platelet Rich Fibrin Membranes for Treatment of Gingival Recession</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>October 6 University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>October 6 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 aim of the present study was to compare between nanocrystalline hydroxyapatite and&#xD;
        tricalcium phosphate carried on PRP membrane in treatment of Miller's class 1 gingival&#xD;
        recession in human.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        gingival recession (GR) is apical movement of the gingival margin beyond the cement-enamel&#xD;
        junction. The use of free gingival grafts, sliding pedicle grafts, subepithelial connective&#xD;
        tissue grafts, envelope or tunnelling techniques, the use of acellular dermal, connective&#xD;
        tissue allografts, guided tissue regeneration, Platelet rich fibrin (PRF), and coronally&#xD;
        advanced flap (CAF) are the surgical methods that have been developed to treat gingival&#xD;
        recession. For treatments of intrabony defects, a synthetic nanocrystalline hydroxyapatite&#xD;
        (NcHA) bone graft has been introduced. Osteoconductivity, bioresorbability, and close contact&#xD;
        are benefits of NcHA material. Critical size defects showed quick healing when the NcHA was&#xD;
        utilised as a bone graft alternative. NcHA binds to bone and increases osteoblast activity to&#xD;
        promote bone regeneration. A promising bone replacement material, tricalcium phosphate (TCP)&#xD;
        is known for its strong bioactivity and resorbable qualities. Tricalcium phosphate (TCP) is&#xD;
        one of the most popular and effective artificial bone substitutes. It is osteoinductive as&#xD;
        well as osteoconductive. These characteristics enable full bone defects regeneration together&#xD;
        with its cell-mediated resorption. In this study, we compared between nanocrystalline&#xD;
        hydroxyapatite and tricalcium phosphate carried on PRP membrane in treatment of Miller's&#xD;
        class 1 gingival recession in human.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2000</start_date>
    <completion_date type="Actual">April 22, 2023</completion_date>
    <primary_completion_date type="Actual">September 20, 2022</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 (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recession height</measure>
      <time_frame>6 months</time_frame>
      <description>measurement recession height</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recession width</measure>
      <time_frame>6 months</time_frame>
      <description>measurement of Recession width</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Height of the keratinized tissue</measure>
      <time_frame>6 months</time_frame>
      <description>measurement of Height of the keratinized tissue</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of root coverage</measure>
      <time_frame>6 months</time_frame>
      <description>It is calculated after 1, 3, 6 months as [RH preoperative - RH postoperative]/RH preoperative) x 100%.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Radiographic assessment</measure>
      <time_frame>6 months</time_frame>
      <description>measurement of buccal bone gain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Probing pocket depth</measure>
      <time_frame>6 months</time_frame>
      <description>measurement of Probing pocket depth</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical attachment level</measure>
      <time_frame>6 months</time_frame>
      <description>measurement of Clinical attachment level</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">20</enrollment>
    <condition>Periodontitis</condition>
    <arm_group>
      <arm_group_label>Nanocrystalline hydroxyapatite</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Nanocrystalline tricalcium phosphate (NcTCP)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>coronally advanced flap</intervention_name>
      <description>coronally advanced flap operation</description>
      <arm_group_label>Nanocrystalline hydroxyapatite</arm_group_label>
      <arm_group_label>Nanocrystalline tricalcium phosphate (NcTCP)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Nanocrystalline hydroxyapatite loaded in PRF</intervention_name>
      <description>Nanocrystalline hydroxyapatite loaded in PRF</description>
      <arm_group_label>Nanocrystalline hydroxyapatite</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Nanocrystalline tricalcium phosphate loaded in PRF</intervention_name>
      <description>Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF</description>
      <arm_group_label>Nanocrystalline tricalcium phosphate (NcTCP)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with good systemic health and no contraindication for periodontal surgery.&#xD;
  &#xD;
            -  Patients who are able to maintain good oral hygiene.&#xD;
  &#xD;
            -  Gingival thickness for the site selected should be ≥1mm.&#xD;
  &#xD;
            -  The height of keratinized gingiva (HKG) for the site selected should be ≥1 mm (HKG is&#xD;
               the distance between the most apical point of the gingival margin and the mucogingival&#xD;
               junction).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active infectious diseases (hepatitis, tuberculosis, HIV, etc….).&#xD;
  &#xD;
            -  Medically compromised patients.&#xD;
  &#xD;
            -  Patients taking medications known to cause gingival enlargement.&#xD;
  &#xD;
            -  Pregnant patients and smokers.&#xD;
  &#xD;
            -  Previous mucogingival surgery at the defect.&#xD;
  &#xD;
            -  Restorations or caries in the area to be treated and non vital tooth.&#xD;
  &#xD;
            -  Teeth which are tilted or rotated.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>October 6 University</investigator_affiliation>
      <investigator_full_name>Enas Elgendy</investigator_full_name>
      <investigator_title>Prof. of Oral Medicine and Periodontology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontitis</mesh_term>
      <mesh_term>Gingival Recession</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/NCT06016894
  org study id: khafrelsheikh university
  nct id: NCT06016894
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the present study was to compare between nanocrystalline hydroxyapatite and
        tricalcium phosphate carried on PRP membrane in treatment of Miller's class 1 gingival
        recession in human.
  gingival recession (GR) is apical movement of the gingival margin beyond the cement-enamel
        junction. The use of free gingival grafts, sliding pedicle grafts, subepithelial connective
        tissue grafts, envelope or tunnelling techniques, the use of acellular dermal, connective
        tissue allografts, guided tissue regeneration, Platelet rich fibrin (PRF), and coronally
        advanced flap (CAF) are the surgical methods that have been developed to treat gingival
        recession. For treatments of intrabony defects, a synthetic nanocrystalline hydroxyapatite
        (NcHA) bone graft has been introduced. Osteoconductivity, bioresorbability, and close contact
        are benefits of NcHA material. Critical size defects showed quick healing when the NcHA was
        utilised as a bone graft alternative. NcHA binds to bone and increases osteoblast activity to
        promote bone regeneration. A promising bone replacement material, tricalcium phosphate (TCP)
        is known for its strong bioactivity and resorbable qualities. Tricalcium phosphate (TCP) is
        one of the most popular and effective artificial bone substitutes. It is osteoinductive as
        well as osteoconductive. These characteristics enable full bone defects regeneration together
        with its cell-mediated resorption. In this study, we compared between nanocrystalline
        hydroxyapatite and tricalcium phosphate carried on PRP membrane in treatment of Miller's
        class 1 gingival recession in human.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Recession height
  time frame: 6 months
  description: measurement recession height
  measure: Recession width
  time frame: 6 months
  description: measurement of Recession width
  measure: Height of the keratinized tissue
  time frame: 6 months
  description: measurement of Height of the keratinized tissue
  measure: Percentage of root coverage
  time frame: 6 months
  description: It is calculated after 1, 3, 6 months as [RH preoperative - RH postoperative]/RH preoperative) x 100%.
  measure: Radiographic assessment
  time frame: 6 months
  description: measurement of buccal bone gain
  measure: Probing pocket depth
  time frame: 6 months
  description: measurement of Probing pocket depth
  measure: Clinical attachment level
  time frame: 6 months
  description: measurement of Clinical attachment level
  arm group label: Nanocrystalline hydroxyapatite
  arm group type: Active Comparator
  description: Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap
  arm group label: Nanocrystalline tricalcium phosphate (NcTCP)
  arm group type: Active Comparator
  description: Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap
  intervention type: Procedure
  intervention name: coronally advanced flap
  description: coronally advanced flap operation
  arm group label: Nanocrystalline hydroxyapatite
  arm group label: Nanocrystalline tricalcium phosphate (NcTCP)
  intervention type: Other
  intervention name: Nanocrystalline hydroxyapatite loaded in PRF
  description: Nanocrystalline hydroxyapatite loaded in PRF
  arm group label: Nanocrystalline hydroxyapatite
  intervention type: Other
  intervention name: Nanocrystalline tricalcium phosphate loaded in PRF
  description: Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF
  arm group label: Nanocrystalline tricalcium phosphate (NcTCP)
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: October 6 University
  investigator full name: Enas Elgendy
  investigator title: Prof. of Oral Medicine and Periodontology
  mesh term: Periodontitis
  mesh term: Gingival Recession
  sharing ipd: No