<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/NCT03838068</url>
  </required_header>
  <id_info>
    <org_study_id>19118</org_study_id>
    <nct_id>NCT03838068</nct_id>
  </id_info>
  <brief_title>Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth</brief_title>
  <official_title>Clinical and Radiographic Evaluation of Pulpotomy Technique for Preserving Vitality of Traumatized Anterior Permanent Immature Teeth: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gihan M Abuelniel ,PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</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>
      Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide&#xD;
      aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) preserving the&#xD;
      vitality of traumatized immature anterior permanent teeth.&#xD;
&#xD;
      Materials and Methods: fifty vital traumatized immature anterior permanent teeth exposed with&#xD;
      symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria&#xD;
      and were equally divided in two groups. Included teeth were randomly assigned to either a&#xD;
      control group (MTA 25 teeth) or a test group (Biodentine 25 teeth). After conducting&#xD;
      pulpotomy and covering pulp stumps with the MTA and Biodentine, treated teeth received&#xD;
      permanent restorations. Blinded clinical and radiographic evaluations were performed at&#xD;
      different time intervals (base line immediate postoperative, 6, 12 and 18 months) according&#xD;
      to clinical and radiographic criteria of success. Data were recorded and analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Informed consent was obtained from all patients prior to treatment, and patients were offered&#xD;
      Root canal treatment in case of treatment failure.&#xD;
&#xD;
      Thirty-three patients who were referred to the postgraduate pediatric dentistry department&#xD;
      clinic for the management of their traumatized permanent incisors teeth were assessed. Only&#xD;
      Patients who had a traumatic incisor tooth with a vital pulp (detected by clinical&#xD;
      signs/symptoms) were included.&#xD;
&#xD;
      Incisors were assigned randomly in the two groups. The MTA group was considered the control&#xD;
      group while the biodentine was the test group.&#xD;
&#xD;
      All patients who were clinically eligible for enrollment in the study went through screening&#xD;
      pre-operative digital periapical radiographic examination to assess the degree of root&#xD;
      development/ formation and any dental infections or anomalies that could interfere with the&#xD;
      planned treatment.&#xD;
&#xD;
      The main investigator performed all pulpotomies. Local anesthesia was administrated followed&#xD;
      by rubber dam isolation, the coronal pulp tissue was excised to the level of the orifice&#xD;
      using a diamond bur with water cooling. Hemostasis was achieved by gentle placement of a&#xD;
      saline-moistened cotton pellet over amputated pulps for 5-10 min. Pulp stumps were covered&#xD;
      with:&#xD;
&#xD;
      In the first group (control group) white mineral trioxide aggregate (MTA) ProRoot® MTA&#xD;
      (Dentsply/ Johnson City,TN,USA) was used as the reference material for comparison and was&#xD;
      prepared according to the manufacturer's instructions. A 3-mm-thick layer of MTA was placed&#xD;
      over the amputated pulps and was gently adapted to the dentinal walls using a wet cotton&#xD;
      pellet deep onto the radicular pulp. A self-cure glass ionomer (GC; GC Corporation, Tokyo,&#xD;
      Japan) was placed over the pulpotomy agent before final restoration of composite resin&#xD;
      (ClearﬁlTM, Kuraray, New York, USA) was done.&#xD;
&#xD;
      In the second group Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des&#xD;
      Fausse´s, France) was mixed according to the manufacturer's instructions, pulpotomy was&#xD;
      performed, radicular pulp was covered, and teeth received self-cure glass ionomer prior to&#xD;
      final restoration with the same technique as in the first group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">August 15, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Access cavity in traumatized central incisors will be assigned into experimental or control group using simple randomization 1:1 by the help of the computer software(random.org).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Patients and their parents, the assessor and the statistician will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>presence of pain,sensitivity to percussion/ palpation</measure>
    <time_frame>18 months</time_frame>
    <description>by asking the patient( questionnaire) (Binary measure) ( Yes or No) where Yes indicates failure of the treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Swelling or sinus tract</measure>
    <time_frame>18 months</time_frame>
    <description>by visual examination (binary measure)( Yes or No) where Yes indicates clinical failure of the treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>presence of mobility</measure>
    <time_frame>18 months</time_frame>
    <description>by the back of the mirror( Binary measure) (Yes or No) where Yes indicates clinical failure of the treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stage of root development</measure>
    <time_frame>18 months</time_frame>
    <description>by radiographic parallel technique ( four root development stages are assessed E, F,G and H) where E is the worse and H is the best stage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of radiolucency</measure>
    <time_frame>18 months</time_frame>
    <description>by radiographic parallel technique (Binary measure) (Yes or No) where Yes indicates radiographic failure of the treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Pulp Exposure, Dental</condition>
  <arm_group>
    <arm_group_label>Mineral trioxide aggegate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>white mineral trioxide aggregate (MTA) calcium silicate-based cement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biodentine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>calcium silicate-based cement that consists of tricalcium silicate, dicalcium silicate, calcium carbonate, calcium oxide, zirconium oxide, and CH.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Biodentine</intervention_name>
    <description>Biodentine is considered a calcium silicate cement</description>
    <arm_group_label>Biodentine</arm_group_label>
    <other_name>Calcium silicate-based</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>mineral trioxide aggregate</intervention_name>
    <description>calcium based silicate cement</description>
    <arm_group_label>Mineral trioxide aggegate</arm_group_label>
    <other_name>MTA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cervical pulpotomy</intervention_name>
    <description>coronal pulp tissue was removed till the orifice</description>
    <arm_group_label>Biodentine</arm_group_label>
    <arm_group_label>Mineral trioxide aggegate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Local Anesthetics Procaine</intervention_name>
    <description>40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance</description>
    <arm_group_label>Biodentine</arm_group_label>
    <arm_group_label>Mineral trioxide aggegate</arm_group_label>
    <other_name>artinibsa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient age range 7.5-9 years.&#xD;
&#xD;
          -  Noncontributory medical history&#xD;
&#xD;
          -  Unilateral/ and or bilateral central incisors tooth with complicated trauma (exposure&#xD;
             size ≥ 1mm)&#xD;
&#xD;
          -  The tooth should give positive response to cold testing&#xD;
&#xD;
          -  Clinical diagnosis of reversible pulpitis without periapical rarefaction&#xD;
&#xD;
          -  The tooth is restorable, mobility was within normal limits&#xD;
&#xD;
          -  No signs of pulpal necrosis including sinus tract or swelling&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Teeth with mature roots&#xD;
&#xD;
          -  Signs and symptoms of irreversible pulpitis&#xD;
&#xD;
          -  Non-restorable teeth&#xD;
&#xD;
          -  Negative response to cold testing, the presence of sinus tract or swelling&#xD;
&#xD;
          -  No pulp exposure&#xD;
&#xD;
          -  Bleeding could not be controlled after full pulpotomy in 6 minutes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gihan M Abuelniel</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gihan Abuelniel</name>
      <address>
        <city>Giza</city>
        <zip>12566</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>December 23, 2019</last_update_submitted>
  <last_update_submitted_qc>December 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Gihan M Abuelniel ,PhD</investigator_full_name>
    <investigator_title>Associate Professor of Pediatric Dentistry</investigator_title>
  </responsible_party>
  <keyword>trauma</keyword>
  <keyword>vital immature</keyword>
  <keyword>MTA</keyword>
  <keyword>Biodentine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Pulp Exposure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Procaine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03838068/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03838068
org study id: 19118
nct id: NCT03838068
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide
      aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) preserving the
      vitality of traumatized immature anterior permanent teeth.

      Materials and Methods: fifty vital traumatized immature anterior permanent teeth exposed with
      symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria
      and were equally divided in two groups. Included teeth were randomly assigned to either a
      control group (MTA 25 teeth) or a test group (Biodentine 25 teeth). After conducting
      pulpotomy and covering pulp stumps with the MTA and Biodentine, treated teeth received
      permanent restorations. Blinded clinical and radiographic evaluations were performed at
      different time intervals (base line immediate postoperative, 6, 12 and 18 months) according
      to clinical and radiographic criteria of success. Data were recorded and analyzed.
Informed consent was obtained from all patients prior to treatment, and patients were offered
      Root canal treatment in case of treatment failure.

      Thirty-three patients who were referred to the postgraduate pediatric dentistry department
      clinic for the management of their traumatized permanent incisors teeth were assessed. Only
      Patients who had a traumatic incisor tooth with a vital pulp (detected by clinical
      signs/symptoms) were included.

      Incisors were assigned randomly in the two groups. The MTA group was considered the control
      group while the biodentine was the test group.

      All patients who were clinically eligible for enrollment in the study went through screening
      pre-operative digital periapical radiographic examination to assess the degree of root
      development/ formation and any dental infections or anomalies that could interfere with the
      planned treatment.

      The main investigator performed all pulpotomies. Local anesthesia was administrated followed
      by rubber dam isolation, the coronal pulp tissue was excised to the level of the orifice
      using a diamond bur with water cooling. Hemostasis was achieved by gentle placement of a
      saline-moistened cotton pellet over amputated pulps for 5-10 min. Pulp stumps were covered
      with:

      In the first group (control group) white mineral trioxide aggregate (MTA) ProRoot® MTA
      (Dentsply/ Johnson City,TN,USA) was used as the reference material for comparison and was
      prepared according to the manufacturer's instructions. A 3-mm-thick layer of MTA was placed
      over the amputated pulps and was gently adapted to the dentinal walls using a wet cotton
      pellet deep onto the radicular pulp. A self-cure glass ionomer (GC; GC Corporation, Tokyo,
      Japan) was placed over the pulpotomy agent before final restoration of composite resin
      (ClearﬁlTM, Kuraray, New York, USA) was done.

      In the second group Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des
      Fausse´s, France) was mixed according to the manufacturer's instructions, pulpotomy was
      performed, radicular pulp was covered, and teeth received self-cure glass ionomer prior to
      final restoration with the same technique as in the first group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Access cavity in traumatized central incisors will be assigned into experimental or control group using simple randomization 1:1 by the help of the computer software(random.org).
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Patients and their parents, the assessor and the statistician will be blinded.
measure: presence of pain,sensitivity to percussion/ palpation
time frame: 18 months
description: by asking the patient( questionnaire) (Binary measure) ( Yes or No) where Yes indicates failure of the treatment
measure: Swelling or sinus tract
time frame: 18 months
description: by visual examination (binary measure)( Yes or No) where Yes indicates clinical failure of the treatment
measure: presence of mobility
time frame: 18 months
description: by the back of the mirror( Binary measure) (Yes or No) where Yes indicates clinical failure of the treatment.
measure: Stage of root development
time frame: 18 months
description: by radiographic parallel technique ( four root development stages are assessed E, F,G and H) where E is the worse and H is the best stage.
measure: Presence of radiolucency
time frame: 18 months
description: by radiographic parallel technique (Binary measure) (Yes or No) where Yes indicates radiographic failure of the treatment.
arm group label: Mineral trioxide aggegate
arm group type: Active Comparator
description: white mineral trioxide aggregate (MTA) calcium silicate-based cement
arm group label: Biodentine
arm group type: Experimental
description: calcium silicate-based cement that consists of tricalcium silicate, dicalcium silicate, calcium carbonate, calcium oxide, zirconium oxide, and CH.
intervention type: Biological
intervention name: Biodentine
description: Biodentine is considered a calcium silicate cement
arm group label: Biodentine
other name: Calcium silicate-based
intervention type: Biological
intervention name: mineral trioxide aggregate
description: calcium based silicate cement
arm group label: Mineral trioxide aggegate
other name: MTA
intervention type: Procedure
intervention name: cervical pulpotomy
description: coronal pulp tissue was removed till the orifice
arm group label: Biodentine
arm group label: Mineral trioxide aggegate
intervention type: Drug
intervention name: Local Anesthetics Procaine
description: 40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance
arm group label: Biodentine
arm group label: Mineral trioxide aggegate
other name: artinibsa
criteria: 
gender: All
minimum age: 7 Years
maximum age: 9 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gihan M Abuelniel
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Gihan M Abuelniel ,PhD
investigator title: Associate Professor of Pediatric Dentistry
mesh term: Dental Pulp Exposure
mesh term: Anesthetics
mesh term: Procaine
mesh term: Anesthetics, Local
sharing ipd: No
provided document: 