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/NCT06031298</url>
    </required_header>
    <id_info>
      <org_study_id>FDASU-REC 1254</org_study_id>
      <nct_id>NCT06031298</nct_id>
    </id_info>
    <brief_title>Influence of Various Healing Intervals on Alveolar Ridge Preservation Using Demineralized Dentin Graft: A Randomized Clinical Trial</brief_title>
    <official_title>Influence of Various Healing Intervals on Alveolar Ridge Preservation Using Demineralized Dentin Graft: A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Statement of the problem:&#xD;
  &#xD;
        The alveolar ridge undergoes various remodeling processes following tooth extraction, but the&#xD;
        ridge resorption continues over time, resulting in hard and soft tissue loss which&#xD;
        complicates prosthodontic rehabilitation whether by dental implants or tooth supported&#xD;
        prosthesis.&#xD;
  &#xD;
        Aim of the study:&#xD;
  &#xD;
        The aim of the study is to assess the influence of the different time intervals on the&#xD;
        healing of the demineralized dentin graft in alveolar ridge preservation (ARP) procedures.&#xD;
  &#xD;
        Materials and methods:&#xD;
  &#xD;
        30 patients with hopeless teeth requiring extraction in maxillary non molar areas and&#xD;
        requiring replacement with dental implants, will be enrolled and recruited from the&#xD;
        outpatient clinic, faculty of dentistry, ain shams university according to the inclusion&#xD;
        criteria. They will be randomly allocated into three equal groups. Group A (n=10) alveolar&#xD;
        ridge preservation will be done with demineralized dentin graft and re-entry at 12 weeks,&#xD;
        group B (n=10) alveolar ridge preservation will be done with demineralized dentin graft and&#xD;
        re-entry at 18 weeks and group C (n=10) alveolar ridge preservation will be done with&#xD;
        demineralized dentin graft and re-entry at 24 weeks. Radiographic assessment will be done&#xD;
        using CBCT to the arch of interest and another cone beam will be done prior to the implant&#xD;
        placement at 11, 17 and 23 weeks based on the study group and a volumetric assessment will be&#xD;
        done with digital subtraction. At the respective times core biopsy will be taken for the&#xD;
        histological assessment, and the implant placement will be done with the implant primary&#xD;
        stability recorded using Ostell. Postoperative medication will be prescribed to the patient&#xD;
        and postoperative instructions will be explained in detail. Follow-up will be performed. Data&#xD;
        collected will be tabulated and statistically analyzed.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2024</primary_completion_date>
    <phase>Phase 4</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Radiographic Assessment</measure>
      <time_frame>Baseline, 12, 18 &amp; 24 months</time_frame>
      <description>Radiographic dimensional changes of the alveolar ridge following ARP using CBCT</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Implant primary stability</measure>
      <time_frame>Time of implant placement at each group</time_frame>
      <description>Implant primary stability using Ostell device</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Histological Assessment</measure>
      <time_frame>Core biopsy obtained at 12, 18 and 24 weeks for the different groups.</time_frame>
      <description>Histomorphometric analysis.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Dentin Graft, Alveolar Ridge Preservation</condition>
    <arm_group>
      <arm_group_label>Alveolar ridge preservation using demineralized dentin graft at 12 weeks.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Alveolar ridge preservation using demineralized dentin graft at 18 weeks</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Alveolar ridge preservation using demineralized dentin graft at 24 weeks</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Dentin Graft</intervention_name>
      <description>Dentin graft is a grafting technique of autogenous origin that uses the teeth extracted from the patient for the graft material preparation.</description>
      <arm_group_label>Alveolar ridge preservation using demineralized dentin graft at 12 weeks.</arm_group_label>
      <arm_group_label>Alveolar ridge preservation using demineralized dentin graft at 18 weeks</arm_group_label>
      <arm_group_label>Alveolar ridge preservation using demineralized dentin graft at 24 weeks</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Systemically free patients (American Society of Anesthesiologists I; ASA I)&#xD;
  &#xD;
            -  Age range 20 - 50.&#xD;
  &#xD;
            -  Non-molar maxillary teeth indicated for extraction.&#xD;
  &#xD;
            -  Patients with extraction sockets having intact bony walls, or no more than one bony&#xD;
               wall dehiscence not extending more than 50% of the total bone height&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Teeth to be extracted or adjacent teeth associated with acute infections.&#xD;
  &#xD;
            -  Smokers.&#xD;
  &#xD;
            -  Patients with other conditions that may affect the treatment [uncontrolled diabetes&#xD;
               mellitus (HbA1c &gt;7.0), liver or kidney failure, any active oral or systemic acute&#xD;
               infections, currently receiving chemo-or radiotherapy or a history of radiotherapy in&#xD;
               the head and neck area, severe hematologic disorders].&#xD;
  &#xD;
            -  Pregnant and lactating females.&#xD;
  &#xD;
            -  Patients with history of lack of compliance to dental visits and unwillingness or&#xD;
               inability to sign the informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mohamed A Mohamed</last_name>
      <phone>+201224005098</phone>
      <email>mohamed.mostafa@miuegypt.edu.eg</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 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>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Mohamed Ahmed Mohamed</investigator_full_name>
      <investigator_title>Assistant Lecturer</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06031298
  org study id: FDASU-REC 1254
  nct id: NCT06031298
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Statement of the problem:
  
        The alveolar ridge undergoes various remodeling processes following tooth extraction, but the
        ridge resorption continues over time, resulting in hard and soft tissue loss which
        complicates prosthodontic rehabilitation whether by dental implants or tooth supported
        prosthesis.
  
        Aim of the study:
  
        The aim of the study is to assess the influence of the different time intervals on the
        healing of the demineralized dentin graft in alveolar ridge preservation (ARP) procedures.
  
        Materials and methods:
  
        30 patients with hopeless teeth requiring extraction in maxillary non molar areas and
        requiring replacement with dental implants, will be enrolled and recruited from the
        outpatient clinic, faculty of dentistry, ain shams university according to the inclusion
        criteria. They will be randomly allocated into three equal groups. Group A (n=10) alveolar
        ridge preservation will be done with demineralized dentin graft and re-entry at 12 weeks,
        group B (n=10) alveolar ridge preservation will be done with demineralized dentin graft and
        re-entry at 18 weeks and group C (n=10) alveolar ridge preservation will be done with
        demineralized dentin graft and re-entry at 24 weeks. Radiographic assessment will be done
        using CBCT to the arch of interest and another cone beam will be done prior to the implant
        placement at 11, 17 and 23 weeks based on the study group and a volumetric assessment will be
        done with digital subtraction. At the respective times core biopsy will be taken for the
        histological assessment, and the implant placement will be done with the implant primary
        stability recorded using Ostell. Postoperative medication will be prescribed to the patient
        and postoperative instructions will be explained in detail. Follow-up will be performed. Data
        collected will be tabulated and statistically analyzed.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Radiographic Assessment
  time frame: Baseline, 12, 18 & 24 months
  description: Radiographic dimensional changes of the alveolar ridge following ARP using CBCT
  measure: Implant primary stability
  time frame: Time of implant placement at each group
  description: Implant primary stability using Ostell device
  measure: Histological Assessment
  time frame: Core biopsy obtained at 12, 18 and 24 weeks for the different groups.
  description: Histomorphometric analysis.
  arm group label: Alveolar ridge preservation using demineralized dentin graft at 12 weeks.
  arm group type: Experimental
  arm group label: Alveolar ridge preservation using demineralized dentin graft at 18 weeks
  arm group type: Active Comparator
  arm group label: Alveolar ridge preservation using demineralized dentin graft at 24 weeks
  arm group type: Active Comparator
  intervention type: Biological
  intervention name: Dentin Graft
  description: Dentin graft is a grafting technique of autogenous origin that uses the teeth extracted from the patient for the graft material preparation.
  arm group label: Alveolar ridge preservation using demineralized dentin graft at 12 weeks.
  arm group label: Alveolar ridge preservation using demineralized dentin graft at 18 weeks
  arm group label: Alveolar ridge preservation using demineralized dentin graft at 24 weeks
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mohamed A Mohamed
  phone: +201224005098
  email: mohamed.mostafa@miuegypt.edu.eg
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Mohamed Ahmed Mohamed
  investigator title: Assistant Lecturer
  sharing ipd: Undecided