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/NCT05984940</url>
    </required_header>
    <id_info>
      <org_study_id>2023/00168</org_study_id>
      <nct_id>NCT05984940</nct_id>
    </id_info>
    <brief_title>Treatment Outcome of Ortho MTA (BioMTA®) Cement vs AH Plus® Bioceramic Sealer (Dentsply).</brief_title>
    <official_title>Clinical Outcome of Root Canal Treatment With Ortho MTA (BioMTA®) Cement and AH Plus® Bioceramic Sealer (Dentsply). A Randomized Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National University Hospital, Singapore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National University Hospital, Singapore</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The use of bioceramics materials as root canal fillings in endodontics is gaining traction&#xD;
        due to their excellent biocompatibility, antibacterial and sealing abilities. They are&#xD;
        dispensed in the form of sealers and cements to be used with gutta-percha or mixed with&#xD;
        liquids to form a paste. Recently, Ortho MTA (BioMTA®) cement is clinically available as a&#xD;
        root filling material, without the need for gutta-percha. The purpose of this randomized&#xD;
        controlled clinical trial is to compare clinical outcome between the novel Ortho MTA&#xD;
        (BioMTA®) and the conventional gutta-percha with bioceramic sealer, when used as obturating&#xD;
        materials in root canal treatment. This research aims to compare the healing outcome of&#xD;
        infected teeth treated by root canal treatment and root-filled using MTA cement (Ortho MTA,&#xD;
        BioMTA® Seoul Korea) or bioceramic sealer (AH Plus® Bioceramic Sealer (Dentsply).&#xD;
  &#xD;
        The sealer can be used alone or in combination with gutta-percha obturating cones, injected&#xD;
        gutta-percha material or core-carriers master cones. In vitro studies have demonstrated the&#xD;
        capability of MTA to generate hydroxyapatite precipitates that penetrate into dentinal&#xD;
        tubules.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The use of bioceramics materials as root canal fillings in endodontics is gaining traction&#xD;
        due to their excellent biocompatibility, antibacterial and sealing abilities. They are&#xD;
        dispensed in the form of sealers and cements to be used with gutta-percha or mixed with&#xD;
        liquids to form a paste.&#xD;
  &#xD;
        In the sealer form, comparisons have been made between bioceramic and conventional&#xD;
        resin-based sealers to study post-operative pain, cytocompatibility and bioactivity potential&#xD;
        and treatment outcomes. In the cement form (MTA and Biodentine), they are largely used in&#xD;
        apexification, regeneration endodontics, perforation repairs and apical surgeries. Recently,&#xD;
        Ortho MTA (BioMTA®) cement is clinically available as a root filling material, without the&#xD;
        need for gutta-percha. There are currently no systematic evaluations of this material&#xD;
        therefore the purpose of this randomized controlled clinical trial is to compare clinical&#xD;
        outcome between the novel Ortho MTA (BioMTA®) and the conventional gutta-percha with&#xD;
        bioceramic sealer, when used as obturating materials in root canal treatment.&#xD;
  &#xD;
        Mineralized Trioxide Aggregate (MTA) is a powder of fine trioxides (tricalcium oxides,&#xD;
        silicon oxide, bismuth oxide) and hydrophilic particles (tricalcium silicate and tricalcium&#xD;
        aluminate). It has good biocompatibility, antibacterial, dimensionally stable, provides&#xD;
        hermetic seal against leakage and capable of stimulating healing and osteogenesis&#xD;
        (bioactive). It is usually mixed with distilled water or saline to form colloidal gel with pH&#xD;
        12.5 and solidifies in 3-4 hours. The release of calcium hydroxide during setting are&#xD;
        responsible for the high alkalinity, antibacterial and bioactivity.&#xD;
  &#xD;
        Ortho MTA (BioMTA®) is an orthograde root canal filling material that was synthesized by&#xD;
        mineral trioxide aggregate's active ingredient through Bio-ceramic manufacturing process. It&#xD;
        was formulated to meet the ideal requirements of root canal filling material necessary for a&#xD;
        clinically effective root canal treatment on cases of file separation, cracked tooth,&#xD;
        severely infected canal, and treatment of acute apical abscess. It is packaged as powder in a&#xD;
        vial and mixed with distilled water where setting begins and continues in vivo.&#xD;
  &#xD;
        AH Plus® Bioceramic Sealer is a root canal sealer conforming to ISO 6876, in a pre-loaded&#xD;
        syringe that does not require any pre-mixing and is set by absorbing moisture from the root&#xD;
        canal environment. The sealer can be used either alone or in combination with gutta-percha&#xD;
        obturating cones, injected gutta-percha material or core-carriers master cones.&#xD;
  &#xD;
        Root canal treatment often uses gutta-percha and sealers to provide 3-dimensional hermetic&#xD;
        seal of a cleaned and disinfected canal. To date, studies exploring root canal treatment with&#xD;
        bioceramic and resin-based sealers have showed comparable results. At the same time, MTA has&#xD;
        been widely used over the past 30 years in a variety of endodontic treatment targeted at&#xD;
        restoring compromised teeth, including as apical barriers/seals for immature tooth with open&#xD;
        apices, in root end surgeries root perforation repairs, preservation of the carious vital&#xD;
        pulp and revitalization of infected immature teeth. Especially among teeth weakened by&#xD;
        infection, the concept of a &quot;monoblock&quot; of root canal filling that is bonded to dentine to&#xD;
        strengthen the tooth, is attractive. While clinical research into the monoblock root filling&#xD;
        created by conventional gutta-percha and sealer has failed to show significant advantage, in&#xD;
        vitro studies have demonstrated the capability of MTA to generate hydroxyapatite precipitates&#xD;
        that penetrate into dentinal tubules, taking the technology one step closer to the monoblock&#xD;
        concept. Hence, the purpose of this research is to compare the healing outcome of infected&#xD;
        teeth treated by root canal treatment and root-filled using MTA cement (Ortho MTA, BioMTA®&#xD;
        Seoul Korea) or bioceramic sealer (AH Plus® Bioceramic Sealer (Dentsply).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Objectives (Change in baseline periapical lesion size at 6 month and 12 month)</measure>
      <time_frame>6, 12 months</time_frame>
      <description>Change in baseline periapical lesion size at 6 month and 12 month</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Secondary Objectives (Change in baseline post-operative pain at Day 1, Day 3 and Day 7 post treatment)</measure>
      <time_frame>1, 3, 7 days</time_frame>
      <description>Change in baseline post-operative pain at Day 1, Day 3 and Day 7 post treatment.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Endodontic Disease</condition>
    <arm_group>
      <arm_group_label>GP and AH Plus sealer</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Root canal obturation using gutta percha and AH Plus® bioceramic sealer.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ortho MTA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Root canal obturation using Ortho MTA cement.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Ortho MTA cement</intervention_name>
      <description>Ortho MTA has a fine granularity for only 2 microns. It penetrates into dental tubules and fuses itself to the surface where it is applied. In addition, it prevents micro-leakage by forming an interfacing layer of hydroxyapatite (Hap) between the OrthoMTA and the canal wall.</description>
      <arm_group_label>Ortho MTA</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>GP and AH Plus sealer</intervention_name>
      <description>AH Plus Sealer is a calcium silicate-based root canal sealer. Tricalcium Silicate interacts with body fluids to release calcium and hydroxide ions that promote hydroxyapatite (HA) formation.</description>
      <arm_group_label>GP and AH Plus sealer</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  A preoperative periapical radiograph will be required for diagnosis.&#xD;
  &#xD;
            -  Subjects at least 21 years old to 95 years old.&#xD;
  &#xD;
            -  Medically healthy&#xD;
  &#xD;
            -  In a patient with multiple teeth requiring root canal treatment, only 1 tooth from&#xD;
               each side will be included and selected at random.&#xD;
  &#xD;
            -  Tooth requiring root canal treatment presenting with periapical radiolucency.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients below 21 years old.&#xD;
  &#xD;
            -  Pregnant women.&#xD;
  &#xD;
            -  Patients with autoimmune disease and uncontrolled diabetes.&#xD;
  &#xD;
            -  Teeth with periodontal probing depth 5mm or more.&#xD;
  &#xD;
            -  Incomplete root formation that is detected radiographically.&#xD;
  &#xD;
            -  Cracked teeth.&#xD;
  &#xD;
            -  Teeth are deemed to have poor restorative prognosis.&#xD;
  &#xD;
            -  Teeth with adjacent teeth on the same side that require root canal treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>95 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Siyi Choo</last_name>
      <phone>+65 82223285</phone>
      <email>choosiyi@nus.edu.sg</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Pulp Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05984940
  org study id: 2023/00168
  nct id: NCT05984940
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The use of bioceramics materials as root canal fillings in endodontics is gaining traction
        due to their excellent biocompatibility, antibacterial and sealing abilities. They are
        dispensed in the form of sealers and cements to be used with gutta-percha or mixed with
        liquids to form a paste. Recently, Ortho MTA (BioMTA®) cement is clinically available as a
        root filling material, without the need for gutta-percha. The purpose of this randomized
        controlled clinical trial is to compare clinical outcome between the novel Ortho MTA
        (BioMTA®) and the conventional gutta-percha with bioceramic sealer, when used as obturating
        materials in root canal treatment. This research aims to compare the healing outcome of
        infected teeth treated by root canal treatment and root-filled using MTA cement (Ortho MTA,
        BioMTA® Seoul Korea) or bioceramic sealer (AH Plus® Bioceramic Sealer (Dentsply).
  
        The sealer can be used alone or in combination with gutta-percha obturating cones, injected
        gutta-percha material or core-carriers master cones. In vitro studies have demonstrated the
        capability of MTA to generate hydroxyapatite precipitates that penetrate into dentinal
        tubules.
  The use of bioceramics materials as root canal fillings in endodontics is gaining traction
        due to their excellent biocompatibility, antibacterial and sealing abilities. They are
        dispensed in the form of sealers and cements to be used with gutta-percha or mixed with
        liquids to form a paste.
  
        In the sealer form, comparisons have been made between bioceramic and conventional
        resin-based sealers to study post-operative pain, cytocompatibility and bioactivity potential
        and treatment outcomes. In the cement form (MTA and Biodentine), they are largely used in
        apexification, regeneration endodontics, perforation repairs and apical surgeries. Recently,
        Ortho MTA (BioMTA®) cement is clinically available as a root filling material, without the
        need for gutta-percha. There are currently no systematic evaluations of this material
        therefore the purpose of this randomized controlled clinical trial is to compare clinical
        outcome between the novel Ortho MTA (BioMTA®) and the conventional gutta-percha with
        bioceramic sealer, when used as obturating materials in root canal treatment.
  
        Mineralized Trioxide Aggregate (MTA) is a powder of fine trioxides (tricalcium oxides,
        silicon oxide, bismuth oxide) and hydrophilic particles (tricalcium silicate and tricalcium
        aluminate). It has good biocompatibility, antibacterial, dimensionally stable, provides
        hermetic seal against leakage and capable of stimulating healing and osteogenesis
        (bioactive). It is usually mixed with distilled water or saline to form colloidal gel with pH
        12.5 and solidifies in 3-4 hours. The release of calcium hydroxide during setting are
        responsible for the high alkalinity, antibacterial and bioactivity.
  
        Ortho MTA (BioMTA®) is an orthograde root canal filling material that was synthesized by
        mineral trioxide aggregate's active ingredient through Bio-ceramic manufacturing process. It
        was formulated to meet the ideal requirements of root canal filling material necessary for a
        clinically effective root canal treatment on cases of file separation, cracked tooth,
        severely infected canal, and treatment of acute apical abscess. It is packaged as powder in a
        vial and mixed with distilled water where setting begins and continues in vivo.
  
        AH Plus® Bioceramic Sealer is a root canal sealer conforming to ISO 6876, in a pre-loaded
        syringe that does not require any pre-mixing and is set by absorbing moisture from the root
        canal environment. The sealer can be used either alone or in combination with gutta-percha
        obturating cones, injected gutta-percha material or core-carriers master cones.
  
        Root canal treatment often uses gutta-percha and sealers to provide 3-dimensional hermetic
        seal of a cleaned and disinfected canal. To date, studies exploring root canal treatment with
        bioceramic and resin-based sealers have showed comparable results. At the same time, MTA has
        been widely used over the past 30 years in a variety of endodontic treatment targeted at
        restoring compromised teeth, including as apical barriers/seals for immature tooth with open
        apices, in root end surgeries root perforation repairs, preservation of the carious vital
        pulp and revitalization of infected immature teeth. Especially among teeth weakened by
        infection, the concept of a "monoblock" of root canal filling that is bonded to dentine to
        strengthen the tooth, is attractive. While clinical research into the monoblock root filling
        created by conventional gutta-percha and sealer has failed to show significant advantage, in
        vitro studies have demonstrated the capability of MTA to generate hydroxyapatite precipitates
        that penetrate into dentinal tubules, taking the technology one step closer to the monoblock
        concept. Hence, the purpose of this research is to compare the healing outcome of infected
        teeth treated by root canal treatment and root-filled using MTA cement (Ortho MTA, BioMTA®
        Seoul Korea) or bioceramic sealer (AH Plus® Bioceramic Sealer (Dentsply).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Primary Objectives (Change in baseline periapical lesion size at 6 month and 12 month)
  time frame: 6, 12 months
  description: Change in baseline periapical lesion size at 6 month and 12 month
  measure: Secondary Objectives (Change in baseline post-operative pain at Day 1, Day 3 and Day 7 post treatment)
  time frame: 1, 3, 7 days
  description: Change in baseline post-operative pain at Day 1, Day 3 and Day 7 post treatment.
  arm group label: GP and AH Plus sealer
  arm group type: Active Comparator
  description: Root canal obturation using gutta percha and AH Plus® bioceramic sealer.
  arm group label: Ortho MTA
  arm group type: Experimental
  description: Root canal obturation using Ortho MTA cement.
  intervention type: Device
  intervention name: Ortho MTA cement
  description: Ortho MTA has a fine granularity for only 2 microns. It penetrates into dental tubules and fuses itself to the surface where it is applied. In addition, it prevents micro-leakage by forming an interfacing layer of hydroxyapatite (Hap) between the OrthoMTA and the canal wall.
  arm group label: Ortho MTA
  intervention type: Device
  intervention name: GP and AH Plus sealer
  description: AH Plus Sealer is a calcium silicate-based root canal sealer. Tricalcium Silicate interacts with body fluids to release calcium and hydroxide ions that promote hydroxyapatite (HA) formation.
  arm group label: GP and AH Plus sealer
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 95 Years
  healthy volunteers: No
  last name: Siyi Choo
  phone: +65 82223285
  email: choosiyi@nus.edu.sg
  responsible party type: Sponsor
  mesh term: Dental Pulp Diseases
  sharing ipd: No