<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/NCT02981693</url>
  </required_header>
  <id_info>
    <org_study_id>DHZhejiangU</org_study_id>
    <nct_id>NCT02981693</nct_id>
  </id_info>
  <brief_title>Evaluation of iRoot SP as Root Canal Sealer: A Clinical Study</brief_title>
  <official_title>1-year Evaluation of iRoot SP as a Root Canal Sealer Compare to AH Plus Sealer: A Prospective Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hui Chen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Dental Hospital of Zhejiang University School of Medicine</source>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP&#xD;
      as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients&#xD;
      needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus&#xD;
      arm randomly. After root canal shaping and cleaning, the teeth were obturated according to&#xD;
      their arms. Assessment of postoperative pain was done 1 week after root canal obturation&#xD;
      using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations were&#xD;
      carried out. Statistical analysis at P &lt; 0.05 was conducted to measure difference between the&#xD;
      arms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Radiographical assessments</measure>
    <time_frame>1 year after root canal therapy</time_frame>
    <description>The periapical status was assessed in the radiographs.Teeth with complete restitution of the periodontal contours were judged as &quot;healed&quot;. Teeth with a clearly decreased size of the periapical radiolucency were judged as &quot;healing&quot;. Teeth with unchanged, increased, or new periapical radiolucency were judged as &quot;failed&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical assessments</measure>
    <time_frame>1 year after root canal therapy</time_frame>
    <description>The root filled tooth was considered clinically successful if there was absence of clinical sign or symptom such as spontaneous pain, sensitivity to percussion or palpation, abnormal mobility, signs of pathology like abscess or sinus tract.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Pain Evaluation</measure>
    <time_frame>1 week after root canal therapy</time_frame>
    <description>Pain was evaluated by using a visual analogue scale (VAS) made of a 10 cm line, where 0 = no pain and 10 = unbearable pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">283</enrollment>
  <condition>Irreversible Pulpitis</condition>
  <condition>Apical Periodontitis</condition>
  <arm_group>
    <arm_group_label>iRoot SP sealer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>iRoot SP sealer was used as root canal sealer in root canal obturation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AH Plus sealer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>AH Plus sealer was used as a gold standard to be compared with iRoot SP sealer in root canal obturation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Root canal sealer</intervention_name>
    <description>Patients who required root canal therapy were enrolled and allotted into either iRoot SP arm or AH Plus arm randomly.For Test Arm: iRoot SP was used as a sealer. Obturation was performed with Gutta-percha cones and root canal sealer by continuous-wave condensation technique. For Control Arm: AH Plus was used as root canal sealer. The same steps were followed for obturation as in Test Arm.</description>
    <arm_group_label>AH Plus sealer</arm_group_label>
    <arm_group_label>iRoot SP sealer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects were required to:&#xD;
&#xD;
          1. have a mature tooth with closed apices;&#xD;
&#xD;
          2. have one single or multi-rooted tooth with irreversible pulpitis, pulp necrosis or&#xD;
             apical periodontitis;&#xD;
&#xD;
          3. be prepared to appear for follow-up and&#xD;
&#xD;
          4. sign informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects with:&#xD;
&#xD;
          1. moderate or severe marginal periodontitis;&#xD;
&#xD;
          2. internal or external root resorption in periapical radiograph;&#xD;
&#xD;
          3. active systemic disease;&#xD;
&#xD;
          4. physical or mental disability,&#xD;
&#xD;
          5. pregnant or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hui Chen</last_name>
    <role>Study Chair</role>
    <affiliation>Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Dental Hospital of Zhejiang University School of Medicine</investigator_affiliation>
    <investigator_full_name>Hui Chen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Pulpitis</mesh_term>
    <mesh_term>Periapical Periodontitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02981693
org study id: DHZhejiangU
nct id: NCT02981693
lead sponsor: 
The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP
      as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients
      needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus
      arm randomly. After root canal shaping and cleaning, the teeth were obturated according to
      their arms. Assessment of postoperative pain was done 1 week after root canal obturation
      using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations were
      carried out. Statistical analysis at P < 0.05 was conducted to measure difference between the
      arms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Radiographical assessments
time frame: 1 year after root canal therapy
description: The periapical status was assessed in the radiographs.Teeth with complete restitution of the periodontal contours were judged as "healed". Teeth with a clearly decreased size of the periapical radiolucency were judged as "healing". Teeth with unchanged, increased, or new periapical radiolucency were judged as "failed".
measure: Clinical assessments
time frame: 1 year after root canal therapy
description: The root filled tooth was considered clinically successful if there was absence of clinical sign or symptom such as spontaneous pain, sensitivity to percussion or palpation, abnormal mobility, signs of pathology like abscess or sinus tract.
measure: Postoperative Pain Evaluation
time frame: 1 week after root canal therapy
description: Pain was evaluated by using a visual analogue scale (VAS) made of a 10 cm line, where 0 = no pain and 10 = unbearable pain.
arm group label: iRoot SP sealer
arm group type: Experimental
description: iRoot SP sealer was used as root canal sealer in root canal obturation.
arm group label: AH Plus sealer
arm group type: Active Comparator
description: AH Plus sealer was used as a gold standard to be compared with iRoot SP sealer in root canal obturation.
intervention type: Procedure
intervention name: Root canal sealer
description: Patients who required root canal therapy were enrolled and allotted into either iRoot SP arm or AH Plus arm randomly.For Test Arm: iRoot SP was used as a sealer. Obturation was performed with Gutta-percha cones and root canal sealer by continuous-wave condensation technique. For Control Arm: AH Plus was used as root canal sealer. The same steps were followed for obturation as in Test Arm.
arm group label: AH Plus sealer
arm group label: iRoot SP sealer
criteria: 
gender: All
minimum age: 12 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hui Chen
role: Study Chair
affiliation: Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University
responsible party type: Sponsor-Investigator
investigator affiliation: The Dental Hospital of Zhejiang University School of Medicine
investigator full name: Hui Chen
investigator title: Professor
mesh term: Periodontitis
mesh term: Pulpitis
mesh term: Periapical Periodontitis