<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/NCT03838094</url>
  </required_header>
  <id_info>
    <org_study_id>19119</org_study_id>
    <nct_id>NCT03838094</nct_id>
  </id_info>
  <brief_title>Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars</brief_title>
  <official_title>Clinical and Radiographic Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars: 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>No</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>
      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) of cariously&#xD;
      exposed vital immature mandibular first permanent molars.&#xD;
&#xD;
      Materials and Methods: sixty immature first mandibular permanent molars cariously exposed&#xD;
      with symptomatic /asymptomatic pulpitis were included in the study according to inclusion&#xD;
      criteria and were equally divided in two groups. Following split-mouth design molars were&#xD;
      randomly assigned to either a control group (MTA 30 molars) or a test group (Biodentine 30&#xD;
      molars). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine,&#xD;
      treated molars received permanent restorations. Blinded clinical and radiographic evaluations&#xD;
      were performed at different time intervals (base line immediate postoperative, 6, 12 and 18&#xD;
      months) according to clinical and radiographic criteria of success. Data were recorded and&#xD;
      analysed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diagnosis:&#xD;
&#xD;
        1. Full history data will be collected, including personal, medical and previous dental&#xD;
           data&#xD;
&#xD;
        2. Clinical examination using mirror and probe to assess the inclusion criteria.&#xD;
&#xD;
        3. Radiographic examination using preoperative digital periapical radiograph to assess the&#xD;
           inclusion criteria.&#xD;
&#xD;
        4. Preoperative photograph will be taken.&#xD;
&#xD;
      Operative procedure:&#xD;
&#xD;
      Experimental group:&#xD;
&#xD;
        1. Injection of local anesthesia and rubber dam isolation.&#xD;
&#xD;
        2. caries and roof of the pulp chamber will be removed by a fissure diamond bur (Diatech,&#xD;
           Heerbrug, Switzerland) and high-speed handpiece with coolant.&#xD;
&#xD;
        3. The pulps will be amputated to the orifice level using a long-shank diamond round bur.&#xD;
&#xD;
        4. Haemostasis will be achieved by gentle placement of a saline-moistened cotton pellet&#xD;
           over amputated pulps for 5-10 min.&#xD;
&#xD;
        5. Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des Fausse´s, France)&#xD;
           will be mixed according to the manufacturer's instructions, radicular pulp will be&#xD;
           covered by the material using a wet cotton pellet.&#xD;
&#xD;
        6. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) will be placed over the&#xD;
           pulpotomy agent as a final restoration.&#xD;
&#xD;
        7. Immediate post-operative radiograph and photograph will be taken.&#xD;
&#xD;
      Control group:&#xD;
&#xD;
      The same procedures will be carried out as the experimental group, but the pulp stumps will&#xD;
      be covered with fast-setting mineral trioxide aggregate (MTA) ENDOCEM MTA (Maruchi, Wonju,&#xD;
      Korea) and will be prepared according to the manufacturer's instructions. A 3-mm-thick layer&#xD;
      of MTA will be placed over the amputated pulps and will be gently adapted to the dentinal&#xD;
      walls using a wet cotton pellet. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan)&#xD;
      will be placed over the pulpotomy agent as a final restoration.&#xD;
&#xD;
      Postoperative care:&#xD;
&#xD;
      Instructions to avoid lip and cheek biting in addition to oral hygiene measures.&#xD;
&#xD;
      Follow up:&#xD;
&#xD;
      Assess the outcomes clinically and radiographically at (baseline, 6, 12 and 18 months).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain, sensitivity to percussion⁄ palpation</measure>
    <time_frame>18 months</time_frame>
    <description>by asking the patient( binary measure)Yes or No, where Yes indicates presence of pain that shows clinical failure</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 No indicates success of the treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>tooth mobility</measure>
    <time_frame>18 months</time_frame>
    <description>by back of the mirror( Binary measure) (Yes or No) where No mobility indicates success of the treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>root formation/development stage</measure>
    <time_frame>18 months</time_frame>
    <description>by radiographic parallel technique to measure the maturity scores used during the radiographic assessment of root development are F, G and H (where F is the worse and H is the best stage)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crown: Root ratio</measure>
    <time_frame>18 months</time_frame>
    <description>by radiographic parallel technique ( the ratio 2:1 or more than 2:1) the ratio more than 2:1 is the best</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apical closure</measure>
    <time_frame>18 months</time_frame>
    <description>by radiographic parallel technique( the apex is blunder apex ,partially open, or constricted) blunder apex is the worse and constricted apex is the best.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>presence of radiolucency</measure>
    <time_frame>18 month</time_frame>
    <description>by radiographic parallel technique( binary measure)( yes or No) if radiolucency is detected this indicates failure of the treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Carious Exposure of Pulp</condition>
  <arm_group>
    <arm_group_label>MTA Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>pulpotomy technique using fast-setting mineral trioxide aggregate (MTA) to be considered the control group for vital pulp therapy and was placed over the amputated pulps for 18 months. This group will be compared with the Biodentine group as the intervention group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biodentine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 mm- thick Biodentine covered radicular pulp to allow pulp regeneration</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Biodentine</intervention_name>
    <description>it is a dentin substitute, a new biologically active material facilitates its penetration through opened dentinal tubules to crystallize interlocking with dentin and provide mechanical properties.</description>
    <arm_group_label>Biodentine group</arm_group_label>
    <other_name>Calcium silicate-based biomaterial</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MTA</intervention_name>
    <description>MTA is a powder that consists of fine hydrophilic particles that set in the presence of moisture. MTA consists of tricalcium silicate, tricalcium aluminate, tricalcium oxide and silicate oxide. MTA was considered a remarkable biocompatible material with various clinical applications that include surgical and non-surgical applications such as pulp capping</description>
    <arm_group_label>MTA Group</arm_group_label>
    <other_name>mineral trioxide aggregate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bilaterally Symptomatic ⁄ asymptomatic vital immature mandibular first permanent&#xD;
             molars (with clinical carious exposure of the pulp and presence of bleeding upon&#xD;
             exposure)&#xD;
&#xD;
               -  Patients with an age range from 7-8 years.&#xD;
&#xD;
               -  Absence of sinus tract, soft tissue swelling.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Molars were excluded if non-restorable.&#xD;
&#xD;
               -  excessive mobility (more than 1 mm horizontally).&#xD;
&#xD;
               -  Radiographic evidence of peri- and ⁄or inter-radicular lesions, internal⁄&#xD;
                  external root resorption, pulp⁄ canal calcifications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gihan M Abuelniel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <verification_date>February 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>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 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>pulp exposure</keyword>
  <keyword>vital immature</keyword>
  <keyword>MTA</keyword>
  <keyword>Biodentine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>only final results</ipd_description>
  </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/94/NCT03838094/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>December 1, 2019</submitted>
    <submission_canceled>December 3, 2019</submission_canceled>
    <submitted>December 3, 2019</submitted>
    <returned>December 20, 2019</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/NCT03838094
org study id: 19119
nct id: NCT03838094
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide
      aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) of cariously
      exposed vital immature mandibular first permanent molars.

      Materials and Methods: sixty immature first mandibular permanent molars cariously exposed
      with symptomatic /asymptomatic pulpitis were included in the study according to inclusion
      criteria and were equally divided in two groups. Following split-mouth design molars were
      randomly assigned to either a control group (MTA 30 molars) or a test group (Biodentine 30
      molars). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine,
      treated molars 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
      analysed.
Diagnosis:

        1. Full history data will be collected, including personal, medical and previous dental
           data

        2. Clinical examination using mirror and probe to assess the inclusion criteria.

        3. Radiographic examination using preoperative digital periapical radiograph to assess the
           inclusion criteria.

        4. Preoperative photograph will be taken.

      Operative procedure:

      Experimental group:

        1. Injection of local anesthesia and rubber dam isolation.

        2. caries and roof of the pulp chamber will be removed by a fissure diamond bur (Diatech,
           Heerbrug, Switzerland) and high-speed handpiece with coolant.

        3. The pulps will be amputated to the orifice level using a long-shank diamond round bur.

        4. Haemostasis will be achieved by gentle placement of a saline-moistened cotton pellet
           over amputated pulps for 5-10 min.

        5. Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des Fausse´s, France)
           will be mixed according to the manufacturer's instructions, radicular pulp will be
           covered by the material using a wet cotton pellet.

        6. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) will be placed over the
           pulpotomy agent as a final restoration.

        7. Immediate post-operative radiograph and photograph will be taken.

      Control group:

      The same procedures will be carried out as the experimental group, but the pulp stumps will
      be covered with fast-setting mineral trioxide aggregate (MTA) ENDOCEM MTA (Maruchi, Wonju,
      Korea) and will be prepared according to the manufacturer's instructions. A 3-mm-thick layer
      of MTA will be placed over the amputated pulps and will be gently adapted to the dentinal
      walls using a wet cotton pellet. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan)
      will be placed over the pulpotomy agent as a final restoration.

      Postoperative care:

      Instructions to avoid lip and cheek biting in addition to oral hygiene measures.

      Follow up:

      Assess the outcomes clinically and radiographically at (baseline, 6, 12 and 18 months).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: pain, sensitivity to percussion⁄ palpation
time frame: 18 months
description: by asking the patient( binary measure)Yes or No, where Yes indicates presence of pain that shows clinical failure
measure: Swelling or sinus tract
time frame: 18 months
description: by visual examination( Binary measure) (Yes or No) where No indicates success of the treatment
measure: tooth mobility
time frame: 18 months
description: by back of the mirror( Binary measure) (Yes or No) where No mobility indicates success of the treatment
measure: root formation/development stage
time frame: 18 months
description: by radiographic parallel technique to measure the maturity scores used during the radiographic assessment of root development are F, G and H (where F is the worse and H is the best stage)
measure: Crown: Root ratio
time frame: 18 months
description: by radiographic parallel technique ( the ratio 2:1 or more than 2:1) the ratio more than 2:1 is the best
measure: Apical closure
time frame: 18 months
description: by radiographic parallel technique( the apex is blunder apex ,partially open, or constricted) blunder apex is the worse and constricted apex is the best.
measure: presence of radiolucency
time frame: 18 month
description: by radiographic parallel technique( binary measure)( yes or No) if radiolucency is detected this indicates failure of the treatment
arm group label: MTA Group
arm group type: Active Comparator
description: pulpotomy technique using fast-setting mineral trioxide aggregate (MTA) to be considered the control group for vital pulp therapy and was placed over the amputated pulps for 18 months. This group will be compared with the Biodentine group as the intervention group
arm group label: Biodentine group
arm group type: Experimental
description: 3 mm- thick Biodentine covered radicular pulp to allow pulp regeneration
intervention type: Biological
intervention name: Biodentine
description: it is a dentin substitute, a new biologically active material facilitates its penetration through opened dentinal tubules to crystallize interlocking with dentin and provide mechanical properties.
arm group label: Biodentine group
other name: Calcium silicate-based biomaterial
intervention type: Biological
intervention name: MTA
description: MTA is a powder that consists of fine hydrophilic particles that set in the presence of moisture. MTA consists of tricalcium silicate, tricalcium aluminate, tricalcium oxide and silicate oxide. MTA was considered a remarkable biocompatible material with various clinical applications that include surgical and non-surgical applications such as pulp capping
arm group label: MTA Group
other name: mineral trioxide aggregate
criteria: 
gender: All
minimum age: 7 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gihan M Abuelniel, PhD
role: Principal Investigator
affiliation: Cairo University
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: Calcium
sharing ipd: No
ipd description: only final results
provided document: 
submitted: December 1, 2019
submission canceled: December 3, 2019
submitted: December 3, 2019
returned: December 20, 2019