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/NCT06002646</url>
    </required_header>
    <id_info>
      <org_study_id>USaimani</org_study_id>
      <nct_id>NCT06002646</nct_id>
    </id_info>
    <brief_title>Lasers as an Alternative to Formocresol and Sodium Hypochlorite Medicaments in Pulpotomy Techniques</brief_title>
    <official_title>Clinical and Radiographic Evaluation of Diode and Er:Cr;YSGG Lasers as an Alternative to Formocresol and Sodium Hypochlorite for Pulpotomy Technique in Primary Molars - Randomized Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Sulaimani</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Sulaimani</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to evaluate the dental lasers as an alternative of&#xD;
        chemical medicaments used in the pulpotomy procedures. The main question it aims to answer&#xD;
        is:&#xD;
  &#xD;
        • Lasers pulpotomies are a viable alternative to the standard Formocresol and Sodium&#xD;
        Hypochlorite medicaments.&#xD;
  &#xD;
        All participants groups (Formocresol, Sodium Hypochlorite, Diode and Er:Cr;YSGG lasers) for&#xD;
        pulpotomy procedure will follow the same clinical protocol, except for the techniques that&#xD;
        will be used for hemostasis of the pulpotomies which either will be achieved by Formocresol&#xD;
        or Sodium Hypochlorite solutions or by Diode or Erbium lasers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All the selected treatment groups (Formocresol, Sodium Hypochlorite, Diode and Er:Cr;YSGG&#xD;
        lasers) will follow the same clinical protocol, except for the techniques that will be used&#xD;
        for hemostasis of the pulpotomies:&#xD;
  &#xD;
          1. Using 2 percent lidocaine with 1: 100,000 epinephrine as a local anesthetic.&#xD;
  &#xD;
          2. Isolation of the teeth with a rubber dam.&#xD;
  &#xD;
          3. Using a diamond round #440 bur in a high-speed hand piece with water cooling to&#xD;
             eliminate caries and expose pulp chambers.&#xD;
  &#xD;
          4. Using a spoon excavator to remove the coronal pulp.&#xD;
  &#xD;
          5. Achieving the hemostasis by:&#xD;
  &#xD;
        I. In first group (Group A): using a 1:5 dilution of Buckley's FC solution. A sterile cotton&#xD;
        pellet will be moistened with a 1:5 concentration formocresol and it will be placed on the&#xD;
        pulp stumps for 5 minutes for achieving hemostasis before being covered with MTA. If&#xD;
        hemostasis will not be achieved after 5 minutes, it will presume that the pulp tissue in the&#xD;
        canal was infected, and the tooth will be removed from the research.&#xD;
  &#xD;
        II. In the second group (Group B): using 3% NaOCl. A sterile cotton pellet will be moistened&#xD;
        with a 3% NaOCl and it will be placed on the pulp chamber for 5 minutes for achieving&#xD;
        hemostasis before being covered with MTA.&#xD;
  &#xD;
        III. In the third group (Group C): In this group hemostasis will be achieved by exposure to&#xD;
        diode laser of 940 nm. The laser energy will be introduced into the canal orifice through a&#xD;
        300 µm optical fiber at 2 W, in a contact mode with continuous mode CW (According to the user&#xD;
        manual) for 1 second at each orifice for three times to achieve complete hemostasis. During&#xD;
        laser application patients, operator and assistant will use protective eye shields according&#xD;
        to the safety measures of the device user manual.&#xD;
  &#xD;
        IV. In the fourth group (Group D): Irradiation of the floor of the pulp chamber with&#xD;
        Er,Cr:YSGG laser 2790 nm ) at a Power of 1.5 w, Frequency of 50 Hz, mode S (soft tissue mode)&#xD;
        , 20%air and no water with a gold handpiece and Tip type MZ6, for 10 sec.(According to the&#xD;
        manufacturer manual iPlus™ software copyright ©2016 BIOLASE, Inc.). In which a fixed char&#xD;
        layer should be formed over the pulpal tissue of the canals orifices. During laser&#xD;
        application patients, operator and assistant will use protective eye shields according to the&#xD;
        safety measures of the device user manual.&#xD;
  &#xD;
          1. Then covering the surface with a 2 mm layer of MTA&#xD;
  &#xD;
          2. The final restoration will be completed in all the four groups, stainless steel crown&#xD;
             will be placed as the final restorative material with a well-fitting marginal adaption&#xD;
             and glass ionomer cement(GC company).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 4, 2023</start_date>
    <completion_date type="Anticipated">January 4, 2024</completion_date>
    <primary_completion_date type="Actual">June 8, 2023</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>Factorial Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>This randomized double blinded clinical trial in which both the participants(patients) and the investigator don't know about which type of treatment groups will be applied.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluation of clinical and radiographical success rate of pulpotomy procedure of FC, and NaOCl techniques and two different types of lasers Diode and Erbium Cr,YSGG lasers</measure>
      <time_frame>one year</time_frame>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Pulp Disease, Dental</condition>
    <condition>Pulp Mummification</condition>
    <arm_group>
      <arm_group_label>first group (Group A)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>using a 1:5 dilution of Buckley's FC (SSA, Produits Dentaires, Switzerland). A sterile cotton pellet will be moistened with a 1:5 concentration formocresol and it will be placed on the pulp stumps for 5 minutes for achieving hemostasis before being covered with MTA. If hemostasis will not be achieved after 5 minutes, it will presume that the pulp tissue in the canal was infected, and the tooth will be removed from the research</description>
    </arm_group>
    <arm_group>
      <arm_group_label>second group (Group B)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>using 3% NaOCl(Tahno-dent, Greece) A sterile cotton pellet will be moistened with a 3% NaOCl and it will be placed on the pulp chamber for 5 minutes for achieving hemostasis before being covered with MTA</description>
    </arm_group>
    <arm_group>
      <arm_group_label>third group (Group C)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this group hemostasis will be achieved by exposure to diode laser (Biolase, epic X) of 940 nm. The laser energy will be introduced into the canal orifice through a 300 µm optical fiber at 2 W, in a contact mode with continuous mode CW(According to the user manual('EpicX_CAN_UM.pdf', no date) for 1 second at each orifice for three times to achieve complete hemostasis. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>fourth group (Group D)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Irradiation of the floor of the pulp chamber with Er,Cr:YSGG laser 2790 nm (Waterlase MD, Biolase) at a Power of 1.5 w, Frequency of 50 Hz, mode S (soft tissue mode) , 20%air and no water with a gold handpiece and Tip type MZ6, for 10 sec.(According to the manufacturer manual iPlus™ software copyright ©2016 BIOLASE, Inc.)('WaterLase-iPlus-UM.pdf', no date). In which a fixed char layer should be formed over the pulpal tissue of the canals orifices. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Formocresol</intervention_name>
      <description>Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with Formocresol solution</description>
      <arm_group_label>first group (Group A)</arm_group_label>
      <other_name>Buckley's solution</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sodium Hypochlorite Solution</intervention_name>
      <description>Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 3% Sodium Hypochlorite Solution.</description>
      <arm_group_label>second group (Group B)</arm_group_label>
      <other_name>NaOCl</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Diode laser</intervention_name>
      <description>Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 940 nm diode laser.</description>
      <arm_group_label>third group (Group C)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Er,Cr:YSGG laser</intervention_name>
      <description>Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 2790nm Er,Cr:YSGG laser.</description>
      <arm_group_label>fourth group (Group D)</arm_group_label>
      <other_name>Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet laser</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Deep carious lesions present in primary molars.&#xD;
  &#xD;
            -  No history of spontaneous or persistent pain.&#xD;
  &#xD;
            -  Lack of clinical evidence of pulpal degeneration, such as pain on percussion, history&#xD;
               of swelling or sinus tracts.&#xD;
  &#xD;
            -  Restorable teeth following completion of the procedure.&#xD;
  &#xD;
            -  Absence of radiographic signs and symptoms of pulpal degeneration.&#xD;
  &#xD;
            -  Following pulpal amputation, hemostasis could be easily achievable.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Uncooperative children.&#xD;
  &#xD;
            -  Children with medically compromised disease.&#xD;
  &#xD;
            -  Presence of radiographical signs and symptoms of pulpal degeneration.&#xD;
  &#xD;
            -  Physiologic root resorption is more than one-third.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>8 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Wasan Adil Fadhil</name>
        <address>
          <city>Sulaymaniyah</city>
          <country>Iraq</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iraq</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Sulaimani</investigator_affiliation>
      <investigator_full_name>Wasan Adil</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Pulp Diseases</mesh_term>
      <mesh_term>Stomatognathic Diseases</mesh_term>
      <mesh_term>Dental Pulp Necrosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chromium</mesh_term>
      <mesh_term>Sodium Hypochlorite</mesh_term>
      <mesh_term>Eusol</mesh_term>
      <mesh_term>Pharmaceutical Solutions</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06002646
  org study id: USaimani
  nct id: NCT06002646
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to evaluate the dental lasers as an alternative of
        chemical medicaments used in the pulpotomy procedures. The main question it aims to answer
        is:
  
        • Lasers pulpotomies are a viable alternative to the standard Formocresol and Sodium
        Hypochlorite medicaments.
  
        All participants groups (Formocresol, Sodium Hypochlorite, Diode and Er:Cr;YSGG lasers) for
        pulpotomy procedure will follow the same clinical protocol, except for the techniques that
        will be used for hemostasis of the pulpotomies which either will be achieved by Formocresol
        or Sodium Hypochlorite solutions or by Diode or Erbium lasers.
  All the selected treatment groups (Formocresol, Sodium Hypochlorite, Diode and Er:Cr;YSGG
        lasers) will follow the same clinical protocol, except for the techniques that will be used
        for hemostasis of the pulpotomies:
  
          1. Using 2 percent lidocaine with 1: 100,000 epinephrine as a local anesthetic.
  
          2. Isolation of the teeth with a rubber dam.
  
          3. Using a diamond round #440 bur in a high-speed hand piece with water cooling to
             eliminate caries and expose pulp chambers.
  
          4. Using a spoon excavator to remove the coronal pulp.
  
          5. Achieving the hemostasis by:
  
        I. In first group (Group A): using a 1:5 dilution of Buckley's FC solution. A sterile cotton
        pellet will be moistened with a 1:5 concentration formocresol and it will be placed on the
        pulp stumps for 5 minutes for achieving hemostasis before being covered with MTA. If
        hemostasis will not be achieved after 5 minutes, it will presume that the pulp tissue in the
        canal was infected, and the tooth will be removed from the research.
  
        II. In the second group (Group B): using 3% NaOCl. A sterile cotton pellet will be moistened
        with a 3% NaOCl and it will be placed on the pulp chamber for 5 minutes for achieving
        hemostasis before being covered with MTA.
  
        III. In the third group (Group C): In this group hemostasis will be achieved by exposure to
        diode laser of 940 nm. The laser energy will be introduced into the canal orifice through a
        300 µm optical fiber at 2 W, in a contact mode with continuous mode CW (According to the user
        manual) for 1 second at each orifice for three times to achieve complete hemostasis. During
        laser application patients, operator and assistant will use protective eye shields according
        to the safety measures of the device user manual.
  
        IV. In the fourth group (Group D): Irradiation of the floor of the pulp chamber with
        Er,Cr:YSGG laser 2790 nm ) at a Power of 1.5 w, Frequency of 50 Hz, mode S (soft tissue mode)
        , 20%air and no water with a gold handpiece and Tip type MZ6, for 10 sec.(According to the
        manufacturer manual iPlus™ software copyright ©2016 BIOLASE, Inc.). In which a fixed char
        layer should be formed over the pulpal tissue of the canals orifices. During laser
        application patients, operator and assistant will use protective eye shields according to the
        safety measures of the device user manual.
  
          1. Then covering the surface with a 2 mm layer of MTA
  
          2. The final restoration will be completed in all the four groups, stainless steel crown
             will be placed as the final restorative material with a well-fitting marginal adaption
             and glass ionomer cement(GC company).
  allocation: Randomized
  intervention model: Factorial Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: This randomized double blinded clinical trial in which both the participants(patients) and the investigator don't know about which type of treatment groups will be applied.
  measure: Evaluation of clinical and radiographical success rate of pulpotomy procedure of FC, and NaOCl techniques and two different types of lasers Diode and Erbium Cr,YSGG lasers
  time frame: one year
  arm group label: first group (Group A)
  arm group type: Active Comparator
  description: using a 1:5 dilution of Buckley's FC (SSA, Produits Dentaires, Switzerland). A sterile cotton pellet will be moistened with a 1:5 concentration formocresol and it will be placed on the pulp stumps for 5 minutes for achieving hemostasis before being covered with MTA. If hemostasis will not be achieved after 5 minutes, it will presume that the pulp tissue in the canal was infected, and the tooth will be removed from the research
  arm group label: second group (Group B)
  arm group type: Experimental
  description: using 3% NaOCl(Tahno-dent, Greece) A sterile cotton pellet will be moistened with a 3% NaOCl and it will be placed on the pulp chamber for 5 minutes for achieving hemostasis before being covered with MTA
  arm group label: third group (Group C)
  arm group type: Experimental
  description: In this group hemostasis will be achieved by exposure to diode laser (Biolase, epic X) of 940 nm. The laser energy will be introduced into the canal orifice through a 300 µm optical fiber at 2 W, in a contact mode with continuous mode CW(According to the user manual('EpicX_CAN_UM.pdf', no date) for 1 second at each orifice for three times to achieve complete hemostasis. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual.
  arm group label: fourth group (Group D)
  arm group type: Experimental
  description: Irradiation of the floor of the pulp chamber with Er,Cr:YSGG laser 2790 nm (Waterlase MD, Biolase) at a Power of 1.5 w, Frequency of 50 Hz, mode S (soft tissue mode) , 20%air and no water with a gold handpiece and Tip type MZ6, for 10 sec.(According to the manufacturer manual iPlus™ software copyright ©2016 BIOLASE, Inc.)('WaterLase-iPlus-UM.pdf', no date). In which a fixed char layer should be formed over the pulpal tissue of the canals orifices. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual.
  intervention type: Drug
  intervention name: Formocresol
  description: Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with Formocresol solution
  arm group label: first group (Group A)
  other name: Buckley's solution
  intervention type: Drug
  intervention name: Sodium Hypochlorite Solution
  description: Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 3% Sodium Hypochlorite Solution.
  arm group label: second group (Group B)
  other name: NaOCl
  intervention type: Device
  intervention name: Diode laser
  description: Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 940 nm diode laser.
  arm group label: third group (Group C)
  intervention type: Device
  intervention name: Er,Cr:YSGG laser
  description: Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 2790nm Er,Cr:YSGG laser.
  arm group label: fourth group (Group D)
  other name: Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet laser
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 8 Years
  healthy volunteers: No
  facility: 
  country: Iraq
  responsible party type: Principal Investigator
  investigator affiliation: University of Sulaimani
  investigator full name: Wasan Adil
  investigator title: Principal investigator
  mesh term: Dental Pulp Diseases
  mesh term: Stomatognathic Diseases
  mesh term: Dental Pulp Necrosis
  mesh term: Chromium
  mesh term: Sodium Hypochlorite
  mesh term: Eusol
  mesh term: Pharmaceutical Solutions