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/NCT06006052</url>
    </required_header>
    <id_info>
      <org_study_id>AnishamsU ASU</org_study_id>
      <nct_id>NCT06006052</nct_id>
    </id_info>
    <brief_title>Regenerative Endodontic in Immature Permanent Teeth</brief_title>
    <official_title>Evaluation of Demineralized Dentin Matrix as a Scaffold for Revascularization in Immature Permanent Incisors: A Randomized Controlled Trial and an In -Vitro Study</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Compare the clinical and radiographic outcomes of demineralized dentin matrix scaffold to&#xD;
        blood clot scaffold in immature permanent incisors with non-vital pulps for one year (in&#xD;
        vivo).&#xD;
  &#xD;
        Investigate the effect of demineralized dentin matrix (DDM) on dental pulp stem cells (DPSCs)&#xD;
        (in vitro).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Necrosis of the immature pulp not only is one of the multiple factors affecting long-term&#xD;
        tooth endurance and preservation but also can act as a source of bacterial infection in the&#xD;
        periapical area and even the maxillofacial spaces&#xD;
  &#xD;
          -  The use of regenerative endodontic techniques (RET) have gained popularity in the past&#xD;
             decade with several endodontic and pediatric dentistry organization recognizing this&#xD;
             technique as a viable technique for immature permanent teeth with necrotic pulps&#xD;
             Regenerative endodontics are defined as biologically based techniques planned to&#xD;
             physiologically replace impaired tooth structure, including dentin and root&#xD;
             constructions, as well as cells of the pulp-dentin complex&#xD;
  &#xD;
          -  They offer the benefit of root lengthening, thickening, and subsequent apical closure&#xD;
             which is not achievable with conventional nonsurgical endodontic treatment (NSET). The&#xD;
             success rate of the blood clot (RET) in immature teeth has been reported to be 97.8%&#xD;
             .The American Association of Endodontists and the European Society of Endodontology&#xD;
             developed evidence-based protocols. To help reduce some of the differences in the RET&#xD;
             steps such as EDTA ethylene diamine tetra acetic acid and sodium hypochlorite use,&#xD;
             however, variations in terms of intracanal medicament, scaffold, and assessment tools&#xD;
             still exist due to the lack of high-quality evidence&#xD;
  &#xD;
        A fundamental component of the regenerative endodontic process is the presence of a scaffold&#xD;
        for stem cells from the apical papilla to adhere, multiply and differentiate. Based on the&#xD;
        results of many studies, the use of blood clot Regenerative procedure is not considered a&#xD;
        true scaffold system. But it is an essential part of any appropriately designed tissue&#xD;
        engineering regenerative endodontic strategy&#xD;
  &#xD;
        .&#xD;
  &#xD;
        Different treatment options and scaffolds have been tested in regenerative endodontics. Only&#xD;
  &#xD;
        some of them exhibited clinical relevance such as blood clot, platelet-rich plasma, and&#xD;
        platelet- rich fibrin as RET scaffolds. Therefore, the use of a suitable scaffold is an&#xD;
        essential part of tissue&#xD;
  &#xD;
        engineering regenerative endodontic strategy .&#xD;
  &#xD;
        Hence, developing a new dental material that retains the proteins or factors that can&#xD;
        stimulate regenerative processes close to the natural process seems promising .&#xD;
        Tissue-derived extracellular matrices have recently been known as naturally-derived scaffolds&#xD;
        for tissue regeneration in various applications and have been revealed to serve as a cultural&#xD;
        substrate on which cells tend to adhere to and proliferate well and can induce regeneration&#xD;
        specific to tissues and sites&#xD;
  &#xD;
        A new extracellular matrix material, demineralized dentin matrix (DDM) derived from extracted&#xD;
        teeth has been found to act as a biocompatible scaffold for the attachment, differentiation,&#xD;
        and proliferation of human DPSCs (dental pulp stem cell) into odontoblast-like cells . The&#xD;
        dentin matrix has proposed roles for directing mineralized tissue repair in dentine and bone;&#xD;
        however, the range of bioactive components in dentine and specific biological effects on&#xD;
        bone-derived mesenchymal stem cells (MSCs) in humans are less well understood&#xD;
  &#xD;
        .&#xD;
  &#xD;
        DDM is an autogenous tooth dentin that has osteoconductive and osteoinductive potential since&#xD;
        it contains extracellular collagen-1 and various growth factors. DDM as a solid blocky&#xD;
        material has less physical stability and sealing ability as a material for regenerative&#xD;
        endodontics.&#xD;
  &#xD;
        Therefore it has been further fabricated into the forms of DDM powder, gel, and sheets to&#xD;
        maintain bioactivity .&#xD;
  &#xD;
        DDM can be prepared with low risks of infection and rejection with noninvasive attainability;&#xD;
        thus, it should be considered a natural resource to be used to full advantage for other&#xD;
        applications&#xD;
  &#xD;
        indicated that DDM as a regenerative biomaterial has potential roles in tissue regeneration.&#xD;
        However, to confirm these trials, further well-designed analyses are needed, and an&#xD;
        evaluation of adverse events in observational studies is also needed. To our knowledge, DDM&#xD;
        has not been investigated as a scaffold in regenerative endodontics for permanent teeth.&#xD;
        Several studies evaluated the regenerative effect of DDM on the dentin-pulp complex through&#xD;
        the direct pulp capping technique, and it was found to possess the ability to activate the&#xD;
        odontogenic differentiation of stem cells resident in the pulp tissues and induce reparative&#xD;
        dentin formation. DDM is also considered for the alveolar ridge, maxillary sinus floor&#xD;
        augmentations, socket preservation, furcation perforation repair, guided bone, and bio root&#xD;
        regenerations as well as bone and cartilage healing&#xD;
  &#xD;
        .&#xD;
  &#xD;
        Hence, this study will be designed to evaluate the regenerative effect of Demineralized&#xD;
        Dentin Matrix as a scaffold in comparison to a conventional blood clot in immature permanent&#xD;
        teeth.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 1, 2022</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 1, 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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the elimination of symptoms at base line at 0,3 and 6 and 9and 12 month</measure>
      <time_frame>at 0,3 and 6 and 9and 12 month</time_frame>
      <description>no history of pain, using Visual Analog Score for pain, measure quality of life.&#xD;
  soft tissue swelling or sinus tract by visual examination , Sensitivity to percussion, Tooth mobility by clinical assessment by operator</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>change root wall thickness and root length in radiographic measurement in millimeter at 0,3,6,9,12 month</measure>
      <time_frame>at 0, 3 and 6 and 9and 12 month</time_frame>
      <description>change root length and width measured in mml by digital radiography using parallel technique</description>
    </secondary_outcome>
    <other_outcome>
      <measure>change root wall thickness and root length using CBCT millimeter at base line and after 12 month</measure>
      <time_frame>at base line and after 12 month</time_frame>
      <description>cone beam computed tomography using OnDemand soft wear and measure the 3d tooth root wall thickness and root length</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Dental Trauma</condition>
    <arm_group>
      <arm_group_label>study group DDM</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group I: 10 teeth will be treated with demineralized dentin matrix attached to collagen membrane as a scaffold in the regenerative endodontic procedure.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group II: 10 teeth will be treated with the conventional regenerative endodontic procedure (blood clot scaffold).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>positive control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group III: 10 teeth will be treated with collage membrane as a scaffold in the regenerative endodontic procedure</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>regeneration technique</intervention_name>
      <description>clinical procedure of regenerative endodontic as AAE mentioned using different material in each group</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>positive control</arm_group_label>
      <arm_group_label>study group DDM</arm_group_label>
      <other_name>regenerative endodontic</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria : patients clinical examination Must be include the following&#xD;
  &#xD;
            -  Patients aged 7-13years at the time of enrolment.&#xD;
  &#xD;
            -  Provision of informed consent by one parent or legal guardian.&#xD;
  &#xD;
            -  At least the patents have one immature permanent anterior tooth diagnosed with&#xD;
               irreversible pulpitis or pulp necrosis with or without periapical lesions.&#xD;
  &#xD;
            -  Restorable teeth ,clinical crown should be enough to use rapper dam Compliant&#xD;
               patient/parent.&#xD;
  &#xD;
            -  Patients are not allergic to medicaments and antibiotics necessary to complete the&#xD;
               procedure (ASA 1 or 2).&#xD;
  &#xD;
            -  Radiologic evidence of open apices (Teeth are considered immature when a minimum of&#xD;
               0.8 mm apical foramen width is evident)&#xD;
  &#xD;
            -  Exclusion Criteria:&#xD;
  &#xD;
            -  the patients will excluded if one of the following criteria is present in the patients&#xD;
  &#xD;
            -  Teeth with root fractures.&#xD;
  &#xD;
            -  Presence of internal or external root resorptions.&#xD;
  &#xD;
            -  Developmental anomalies of the root.&#xD;
  &#xD;
            -  Presence of periapical radiolucency more than 10 mm.&#xD;
  &#xD;
            -  Tooth with class III mobility.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>13 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>nagwa khattab, professor</last_name>
      <role>Study Director</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marwa Abozed</last_name>
      <phone>00201142621411</phone>
      <email>marwaabozed@dent.asu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>mariem wassel</last_name>
      <phone>00201064871416</phone>
      <email>mariem.wassel@dent.asu.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ain shams university</name>
        <address>
          <city>Cairo</city>
          <state>Alabbassia</state>
          <zip>11566</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>marwa abozed</last_name>
        <phone>00201142621411</phone>
        <email>marwaabozed@dent.asu.edu.eg</email>
      </contact>
      <contact_backup>
        <last_name>mariem wassel</last_name>
        <phone>00201064871416</phone>
        <email>mariem.wassel@dent.asu.edu.eg</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <link>
      <url>https://doi.org/10.1016/j.joen.2020.05.016</url>
      <description>Regeneration of Tooth with Allogenous, Autoclaved Treated Dentin Matrix with Dental Pulpal Stem Cells: An In Vivo Study</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Marwa Ahmed Abozed mahmoud</investigator_full_name>
      <investigator_title>Assistant Lecturer</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>regeneration immature teeth</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 4, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/52/NCT06006052/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06006052
  org study id: AnishamsU ASU
  nct id: NCT06006052
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  Compare the clinical and radiographic outcomes of demineralized dentin matrix scaffold to
        blood clot scaffold in immature permanent incisors with non-vital pulps for one year (in
        vivo).
  
        Investigate the effect of demineralized dentin matrix (DDM) on dental pulp stem cells (DPSCs)
        (in vitro).
  Necrosis of the immature pulp not only is one of the multiple factors affecting long-term
        tooth endurance and preservation but also can act as a source of bacterial infection in the
        periapical area and even the maxillofacial spaces
  
          -  The use of regenerative endodontic techniques (RET) have gained popularity in the past
             decade with several endodontic and pediatric dentistry organization recognizing this
             technique as a viable technique for immature permanent teeth with necrotic pulps
             Regenerative endodontics are defined as biologically based techniques planned to
             physiologically replace impaired tooth structure, including dentin and root
             constructions, as well as cells of the pulp-dentin complex
  
          -  They offer the benefit of root lengthening, thickening, and subsequent apical closure
             which is not achievable with conventional nonsurgical endodontic treatment (NSET). The
             success rate of the blood clot (RET) in immature teeth has been reported to be 97.8%
             .The American Association of Endodontists and the European Society of Endodontology
             developed evidence-based protocols. To help reduce some of the differences in the RET
             steps such as EDTA ethylene diamine tetra acetic acid and sodium hypochlorite use,
             however, variations in terms of intracanal medicament, scaffold, and assessment tools
             still exist due to the lack of high-quality evidence
  
        A fundamental component of the regenerative endodontic process is the presence of a scaffold
        for stem cells from the apical papilla to adhere, multiply and differentiate. Based on the
        results of many studies, the use of blood clot Regenerative procedure is not considered a
        true scaffold system. But it is an essential part of any appropriately designed tissue
        engineering regenerative endodontic strategy
  
        .
  
        Different treatment options and scaffolds have been tested in regenerative endodontics. Only
  
        some of them exhibited clinical relevance such as blood clot, platelet-rich plasma, and
        platelet- rich fibrin as RET scaffolds. Therefore, the use of a suitable scaffold is an
        essential part of tissue
  
        engineering regenerative endodontic strategy .
  
        Hence, developing a new dental material that retains the proteins or factors that can
        stimulate regenerative processes close to the natural process seems promising .
        Tissue-derived extracellular matrices have recently been known as naturally-derived scaffolds
        for tissue regeneration in various applications and have been revealed to serve as a cultural
        substrate on which cells tend to adhere to and proliferate well and can induce regeneration
        specific to tissues and sites
  
        A new extracellular matrix material, demineralized dentin matrix (DDM) derived from extracted
        teeth has been found to act as a biocompatible scaffold for the attachment, differentiation,
        and proliferation of human DPSCs (dental pulp stem cell) into odontoblast-like cells . The
        dentin matrix has proposed roles for directing mineralized tissue repair in dentine and bone;
        however, the range of bioactive components in dentine and specific biological effects on
        bone-derived mesenchymal stem cells (MSCs) in humans are less well understood
  
        .
  
        DDM is an autogenous tooth dentin that has osteoconductive and osteoinductive potential since
        it contains extracellular collagen-1 and various growth factors. DDM as a solid blocky
        material has less physical stability and sealing ability as a material for regenerative
        endodontics.
  
        Therefore it has been further fabricated into the forms of DDM powder, gel, and sheets to
        maintain bioactivity .
  
        DDM can be prepared with low risks of infection and rejection with noninvasive attainability;
        thus, it should be considered a natural resource to be used to full advantage for other
        applications
  
        indicated that DDM as a regenerative biomaterial has potential roles in tissue regeneration.
        However, to confirm these trials, further well-designed analyses are needed, and an
        evaluation of adverse events in observational studies is also needed. To our knowledge, DDM
        has not been investigated as a scaffold in regenerative endodontics for permanent teeth.
        Several studies evaluated the regenerative effect of DDM on the dentin-pulp complex through
        the direct pulp capping technique, and it was found to possess the ability to activate the
        odontogenic differentiation of stem cells resident in the pulp tissues and induce reparative
        dentin formation. DDM is also considered for the alveolar ridge, maxillary sinus floor
        augmentations, socket preservation, furcation perforation repair, guided bone, and bio root
        regenerations as well as bone and cartilage healing
  
        .
  
        Hence, this study will be designed to evaluate the regenerative effect of Demineralized
        Dentin Matrix as a scaffold in comparison to a conventional blood clot in immature permanent
        teeth.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: the elimination of symptoms at base line at 0,3 and 6 and 9and 12 month
  time frame: at 0,3 and 6 and 9and 12 month
  description: no history of pain, using Visual Analog Score for pain, measure quality of life.
  soft tissue swelling or sinus tract by visual examination , Sensitivity to percussion, Tooth mobility by clinical assessment by operator
  measure: change root wall thickness and root length in radiographic measurement in millimeter at 0,3,6,9,12 month
  time frame: at 0, 3 and 6 and 9and 12 month
  description: change root length and width measured in mml by digital radiography using parallel technique
  measure: change root wall thickness and root length using CBCT millimeter at base line and after 12 month
  time frame: at base line and after 12 month
  description: cone beam computed tomography using OnDemand soft wear and measure the 3d tooth root wall thickness and root length
  arm group label: study group DDM
  arm group type: Experimental
  description: Group I: 10 teeth will be treated with demineralized dentin matrix attached to collagen membrane as a scaffold in the regenerative endodontic procedure.
  arm group label: Control group
  arm group type: Active Comparator
  description: Group II: 10 teeth will be treated with the conventional regenerative endodontic procedure (blood clot scaffold).
  arm group label: positive control
  arm group type: Active Comparator
  description: Group III: 10 teeth will be treated with collage membrane as a scaffold in the regenerative endodontic procedure
  intervention type: Combination Product
  intervention name: regeneration technique
  description: clinical procedure of regenerative endodontic as AAE mentioned using different material in each group
  arm group label: Control group
  arm group label: positive control
  arm group label: study group DDM
  other name: regenerative endodontic
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 13 Years
  healthy volunteers: No
  last name: nagwa khattab, professor
  role: Study Director
  affiliation: Ain Shams University
  last name: Marwa Abozed
  phone: 00201142621411
  email: marwaabozed@dent.asu.edu.eg
  last name: mariem wassel
  phone: 00201064871416
  email: mariem.wassel@dent.asu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  url: https://doi.org/10.1016/j.joen.2020.05.016
  description: Regeneration of Tooth with Allogenous, Autoclaved Treated Dentin Matrix with Dental Pulpal Stem Cells: An In Vivo Study
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Marwa Ahmed Abozed mahmoud
  investigator title: Assistant Lecturer
  sharing ipd: No
  ipd description: regeneration immature teeth
  provided document: 