<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/NCT03795636</url>
  </required_header>
  <id_info>
    <org_study_id>307</org_study_id>
    <nct_id>NCT03795636</nct_id>
  </id_info>
  <brief_title>Allium Sativum Extract as an Irrigant</brief_title>
  <official_title>Allium Sativum Extract as an Irrigant in Pulpectomy of Primary Molars: 12 Month In-vivo Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minia University</source>
  <oversight_info>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Garlic extract as herbal compound has potent antibacterial properties and can be used safely&#xD;
      as an irrigant for pulpectomy procedure of primary molars root canals with high clinical and&#xD;
      radiographic outcomes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: This study indented to assess the clinical and radiographic assessment of garlic extract&#xD;
      as an intracanal irrigant for pulpectomy of primary molars.&#xD;
&#xD;
      Methodology: 91 child with 100 teeth submitted into this study were equally categorized into&#xD;
      the test group (group 1) which irrigated with garlic extract and control group (group 2) that&#xD;
      received sodium hypochlorite (NaOCl). Then, each group has been subjected to further&#xD;
      specification according to the tooth preoperative clinical and radiographic features into has&#xD;
      been into 2 subgroups. Clinical and radiographic success rates were checked at 3, 6 and 12&#xD;
      months. Fisher's exact test for binary variable was used for data analysis with p-value ≤&#xD;
      0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2016</start_date>
  <completion_date type="Actual">August 15, 2018</completion_date>
  <primary_completion_date type="Actual">August 13, 2018</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>oral examination</measure>
    <time_frame>12 months</time_frame>
    <description>Pain assessment using Visual Analog Score for pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>radiographic success or failure</measure>
    <time_frame>12 months</time_frame>
    <description>Radiographic assessment using periapical radiograph and score (0) applied for absence of radiolucency and score (1) for presence of radiolucency</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Types of failures</measure>
    <time_frame>12 months</time_frame>
    <description>detecting the percent of different failure types accompanied with pulpectomy procedures after using garlic as an irrigant solution.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Infected Root Canals of Primary Molars</condition>
  <arm_group>
    <arm_group_label>Garlic extracts root canal irrigation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group treated with garlic extract&#xD;
A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium hypochlorite root canal irrigation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group which treated conventionally using .5 ml of 5.25% NaOCl (COLTENE®ENDO, Switzerland)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Garlic extract</intervention_name>
    <description>A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water</description>
    <arm_group_label>Garlic extracts root canal irrigation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NaOCl (COLTENE®)</intervention_name>
    <description>Sodium hypochlorite</description>
    <arm_group_label>Sodium hypochlorite root canal irrigation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Class I or II according to American Society of Anesthesiologists (ASA)&#xD;
&#xD;
          2. Irreversible pulpititis recognised through; (1) profuse bleeding from root canal&#xD;
             orifices after complete debridement of coronal pulp tissue and cannot be dominated by&#xD;
             moist cotton pellet. (2) History of lingered thermal pain spontaneous nocturnal pain&#xD;
&#xD;
          3. Necrotic pulp tissues which may be asymptomatic or manifested with dull ache pain&#xD;
&#xD;
          4. Pathological tooth mobility&#xD;
&#xD;
          5. Percussion sensitivity&#xD;
&#xD;
          6. Swelling close to involved tooth accompanied with or without fistula Radiographic&#xD;
             characteristics of the root and supporting structures&#xD;
&#xD;
        1. Normal radiographic findings&#xD;
&#xD;
        2. Interruption of lamina dura&#xD;
&#xD;
        3. Furcation radiolucency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Specifications of exclusion&#xD;
&#xD;
               1. Uncooperativeness of child and/or parents or caregivers behavior&#xD;
&#xD;
               2. Unrestorable tooth&#xD;
&#xD;
               3. Presence of internal root resorption&#xD;
&#xD;
               4. Presence of calcific metamorphosis inside root canals&#xD;
&#xD;
               5. Presence of root resorption exceeding one third of its length&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>October 23, 2019</last_update_submitted>
  <last_update_submitted_qc>October 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Minia University</investigator_affiliation>
    <investigator_full_name>Ahmad Elheeny</investigator_full_name>
    <investigator_title>Lecturer of pediatric dentistry</investigator_title>
  </responsible_party>
  <keyword>Primary molars</keyword>
  <keyword>Garlic extract</keyword>
  <keyword>Sodium hypochlorite</keyword>
  <keyword>Pulpectomy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 11, 2020</submitted>
    <returned>February 26, 2020</returned>
  </pending_results>
  <!-- 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/NCT03795636
org study id: 307
nct id: NCT03795636
lead sponsor: 
is fda regulated device: No
Garlic extract as herbal compound has potent antibacterial properties and can be used safely
      as an irrigant for pulpectomy procedure of primary molars root canals with high clinical and
      radiographic outcomes
Aim: This study indented to assess the clinical and radiographic assessment of garlic extract
      as an intracanal irrigant for pulpectomy of primary molars.

      Methodology: 91 child with 100 teeth submitted into this study were equally categorized into
      the test group (group 1) which irrigated with garlic extract and control group (group 2) that
      received sodium hypochlorite (NaOCl). Then, each group has been subjected to further
      specification according to the tooth preoperative clinical and radiographic features into has
      been into 2 subgroups. Clinical and radiographic success rates were checked at 3, 6 and 12
      months. Fisher's exact test for binary variable was used for data analysis with p-value ≤
      0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: oral examination
time frame: 12 months
description: Pain assessment using Visual Analog Score for pain
measure: radiographic success or failure
time frame: 12 months
description: Radiographic assessment using periapical radiograph and score (0) applied for absence of radiolucency and score (1) for presence of radiolucency
measure: Types of failures
time frame: 12 months
description: detecting the percent of different failure types accompanied with pulpectomy procedures after using garlic as an irrigant solution.
arm group label: Garlic extracts root canal irrigation group
arm group type: Experimental
description: Experimental group treated with garlic extract
A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water
arm group label: Sodium hypochlorite root canal irrigation group
arm group type: Active Comparator
description: Control group which treated conventionally using .5 ml of 5.25% NaOCl (COLTENE®ENDO, Switzerland)
intervention type: Other
intervention name: Garlic extract
description: A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water
arm group label: Garlic extracts root canal irrigation group
intervention type: Other
intervention name: NaOCl (COLTENE®)
description: Sodium hypochlorite
arm group label: Sodium hypochlorite root canal irrigation group
criteria: 
gender: All
minimum age: 4 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Minia University
investigator full name: Ahmad Elheeny
investigator title: Lecturer of pediatric dentistry
sharing ipd: No
submitted: February 11, 2020
returned: February 26, 2020