<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/NCT03833401</url>
  </required_header>
  <id_info>
    <org_study_id>18-000077</org_study_id>
    <nct_id>NCT03833401</nct_id>
  </id_info>
  <brief_title>Dental Pulp Regeneration by Autologous Tissue Transplantation</brief_title>
  <official_title>Dental Pulp Regeneration for Root Canals by Autologous Tissue Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</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>
      The purpose of this study is to develop new improved therapy for teeth that require root&#xD;
      canals due to tooth infection or tooth inflammation. Investigators will recruit total of 50&#xD;
      participants from the age group 7 - 50 at the UCLA School of Dentistry Endodontic clinic. The&#xD;
      participants will be divided into two groups, one will receive traditional therapy, which may&#xD;
      include root canal or a procedure called &quot;revascularization,&quot; which is a procedure trying to&#xD;
      regrow the tissue inside the tooth. The other group of participants will receive the test&#xD;
      treatment, which will involve harvesting of pulp tissues from the same tooth or other teeth&#xD;
      that are planned for extraction. Investigators will prepare these tissues and place the&#xD;
      tissues back into the cleaned root canal space with induced bleeding to allow regrowth of the&#xD;
      tissue. For all participants, investigators will follow up after 6, 12, and 24 months in a&#xD;
      shorter appointment, which may involve taking x-ray and clinical exam.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the study is to test whether autologous pulpal mesenchymal stem cells (MSCs) is&#xD;
      capable of de novo regeneration of pulp-dentin complex and restoration of normal pulp&#xD;
      physiology in teeth with necrotic or inflamed pulp. This is a highly novel study that will&#xD;
      bring the regenerative endodontic approaches to the next level. Furthermore,&#xD;
      revascularization approaches, as delivered in today's endodontic offices, present several&#xD;
      challenges, including lack of de novo pulp-dentin regeneration, and frequent occurrence of&#xD;
      intracanal calcification. These findings attest to the limitation of revascularization as a&#xD;
      regenerative endodontic procedure (REP) and necessitates advent of novel approach for&#xD;
      functional restoration of dental pulp. The ultimate objective of the current study is to&#xD;
      develop a new REP that allows for de novo regeneration of functional dental pulp, which can&#xD;
      be readily performed in a chair-side manner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</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>
    <intervention_model_description>This study will involve two Arms; one serving as sham comparator, and the other arm serving as experimental (test) group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Randomized</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in radiographic assessment for periapical inflammation</measure>
    <time_frame>6 months, 12 months, and 24 months</time_frame>
    <description>This outcome will test the effect of treatment in either Arm on resolving periapical inflammation, which will be assessed by radiographic imaging and clinical examination. Healing of periapical inflammatory lesion will be measured by radiographic imaging to note changes in the size of pre-existing radiograph periapical lesions after the treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in pulpal sensibility to temperature and electric current</measure>
    <time_frame>6 months, 12 months, and 24 months</time_frame>
    <description>This outcome will test whether the treatment in either Arm will allow revitalization of pulp tissues, by means of thermal and electrical testing of pulp vitality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in root dentin thickness of root canals</measure>
    <time_frame>6 months, 12 months, and 24 months</time_frame>
    <description>This outcome will assess changes in root dentin thickness after treatment in either arm. We will also determine if the apical opening (foramen) will close in cases that initially present with open apices. This assessment will be based on radiographic imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in root length</measure>
    <time_frame>6 months, 12 months, and 24 months</time_frame>
    <description>This outcome will assess changes in root length after treatment in either arm. This assessment will be based on radiographic imaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of root canal calcification in teeth treated by revascularization with or without tissue transplantation</measure>
    <time_frame>6 months, 12 months, and 24 months</time_frame>
    <description>This outcome will assess the degree of root canal calcification in teeth treated in either Arm by radiographic imaging. Degree of calcification will be measured by means of different levels of radio-opacity in routine dental X rays.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Dental Pulp Regeneration</condition>
  <arm_group>
    <arm_group_label>Root canal revascularization</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Root canal disinfection and revascularization without tissue transplantation. This will serve as control group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Autologous tissue transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Root canal disinfection will be performed and revascularization will be induced with autologous tissue transplantation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Autologous tissue transplantation</intervention_name>
    <description>Root canal disinfection and revascularization with patient's own minced pulp tissues</description>
    <arm_group_label>Autologous tissue transplantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Root canal revascularization</intervention_name>
    <description>Root canal disinfection and revascularization without tissue transplantation</description>
    <arm_group_label>Root canal revascularization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female participants at ages of 7 - 50 y.o. presenting with a tooth&#xD;
             diagnosed with complete or partial necrosis of the pulp or irreversible pulpitis.&#xD;
&#xD;
          -  Participants presenting with donor pulp tissue, either from existing deciduous teeth&#xD;
             or from permanent teeth treatment planned for extraction, e.g., second premolars for&#xD;
             orthodontic extraction or third molars.&#xD;
&#xD;
          -  Participants presenting with irreversible pulpitis and partial necrosis, i.e., visible&#xD;
             pulpal tissues during access opening and canal debridement.&#xD;
&#xD;
          -  Participants with immature root apices, including those with partially closed apex,&#xD;
             that require root canal procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with any systemic conditions preventing routine dental procedures or&#xD;
             requiring medication that interfere with healing or induce bleeding.&#xD;
&#xD;
          -  Participants with avulsed, replanted teeth with resultant pulp necrosis.&#xD;
&#xD;
          -  Participants with vertical root fracture/cracks.&#xD;
&#xD;
          -  Participants with teeth that are not restorable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mo Kang, DDS,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mo Kang, DDS,PhD</last_name>
    <phone>310-825-8048</phone>
    <email>mkang@dentistry.ucla.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yangpei Cao, DDS, MS</last_name>
    <phone>310-825-7165</phone>
    <email>ycao@dentistry.ucla.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UCLA School of Dentistry</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa Gotori-Koga</last_name>
      <phone>310-825-7141</phone>
      <email>lgotori@dentistry.ucla.edu</email>
    </contact>
    <investigator>
      <last_name>Yangpei Cao, DDS,MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Mo K. Kang, DDS, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03833401
org study id: 18-000077
nct id: NCT03833401
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to develop new improved therapy for teeth that require root
      canals due to tooth infection or tooth inflammation. Investigators will recruit total of 50
      participants from the age group 7 - 50 at the UCLA School of Dentistry Endodontic clinic. The
      participants will be divided into two groups, one will receive traditional therapy, which may
      include root canal or a procedure called "revascularization," which is a procedure trying to
      regrow the tissue inside the tooth. The other group of participants will receive the test
      treatment, which will involve harvesting of pulp tissues from the same tooth or other teeth
      that are planned for extraction. Investigators will prepare these tissues and place the
      tissues back into the cleaned root canal space with induced bleeding to allow regrowth of the
      tissue. For all participants, investigators will follow up after 6, 12, and 24 months in a
      shorter appointment, which may involve taking x-ray and clinical exam.
The goal of the study is to test whether autologous pulpal mesenchymal stem cells (MSCs) is
      capable of de novo regeneration of pulp-dentin complex and restoration of normal pulp
      physiology in teeth with necrotic or inflamed pulp. This is a highly novel study that will
      bring the regenerative endodontic approaches to the next level. Furthermore,
      revascularization approaches, as delivered in today's endodontic offices, present several
      challenges, including lack of de novo pulp-dentin regeneration, and frequent occurrence of
      intracanal calcification. These findings attest to the limitation of revascularization as a
      regenerative endodontic procedure (REP) and necessitates advent of novel approach for
      functional restoration of dental pulp. The ultimate objective of the current study is to
      develop a new REP that allows for de novo regeneration of functional dental pulp, which can
      be readily performed in a chair-side manner.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study will involve two Arms; one serving as sham comparator, and the other arm serving as experimental (test) group.
primary purpose: Treatment
masking: Single (Participant)
masking description: Randomized
measure: Changes in radiographic assessment for periapical inflammation
time frame: 6 months, 12 months, and 24 months
description: This outcome will test the effect of treatment in either Arm on resolving periapical inflammation, which will be assessed by radiographic imaging and clinical examination. Healing of periapical inflammatory lesion will be measured by radiographic imaging to note changes in the size of pre-existing radiograph periapical lesions after the treatment.
measure: Changes in pulpal sensibility to temperature and electric current
time frame: 6 months, 12 months, and 24 months
description: This outcome will test whether the treatment in either Arm will allow revitalization of pulp tissues, by means of thermal and electrical testing of pulp vitality.
measure: Changes in root dentin thickness of root canals
time frame: 6 months, 12 months, and 24 months
description: This outcome will assess changes in root dentin thickness after treatment in either arm. We will also determine if the apical opening (foramen) will close in cases that initially present with open apices. This assessment will be based on radiographic imaging.
measure: Changes in root length
time frame: 6 months, 12 months, and 24 months
description: This outcome will assess changes in root length after treatment in either arm. This assessment will be based on radiographic imaging.
measure: Changes of root canal calcification in teeth treated by revascularization with or without tissue transplantation
time frame: 6 months, 12 months, and 24 months
description: This outcome will assess the degree of root canal calcification in teeth treated in either Arm by radiographic imaging. Degree of calcification will be measured by means of different levels of radio-opacity in routine dental X rays.
arm group label: Root canal revascularization
arm group type: Sham Comparator
description: Root canal disinfection and revascularization without tissue transplantation. This will serve as control group.
arm group label: Autologous tissue transplantation
arm group type: Experimental
description: Root canal disinfection will be performed and revascularization will be induced with autologous tissue transplantation.
intervention type: Procedure
intervention name: Autologous tissue transplantation
description: Root canal disinfection and revascularization with patient's own minced pulp tissues
arm group label: Autologous tissue transplantation
intervention type: Procedure
intervention name: Root canal revascularization
description: Root canal disinfection and revascularization without tissue transplantation
arm group label: Root canal revascularization
criteria: 
gender: All
minimum age: 7 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mo Kang, DDS,PhD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Mo Kang, DDS,PhD
phone: 310-825-8048
email: mkang@dentistry.ucla.edu
last name: Yangpei Cao, DDS, MS
phone: 310-825-7165
email: ycao@dentistry.ucla.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Mo K. Kang, DDS, PhD
investigator title: Professor
sharing ipd: No