<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/NCT02201641</url>
  </required_header>
  <id_info>
    <org_study_id>11-LO-1893</org_study_id>
    <nct_id>NCT02201641</nct_id>
  </id_info>
  <brief_title>Efficacy of Calcium Silicate Pulp-capping; a Randomized Controlled Clinical Trial</brief_title>
  <official_title>Efficacy of Calcium Silicate Pulp-capping; a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to investigate the tooth nerve response to a recently introduced therapeutic&#xD;
      filling material (calcium silicate cement) called Biodentine and to assess the quality of the&#xD;
      overlying filling compared to another material (glass ionomer cement) called Fuji IX used&#xD;
      more commonly. Also to compare the effectiveness of cone beam computed tomography x-rays&#xD;
      compared to conventional periapical x-rays in detecting lesions around these teeth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tooth decay is one of the most widespread diseases in the world. Very often, a patient comes&#xD;
      to the dental clinic when experiencing pain which commonly means the decay is deep and is&#xD;
      very close to or has penetrated the nerve of the tooth. When the decay is very close to the&#xD;
      pulp or nerve of the tooth, a procedure called pulp capping is done in an attempt to save the&#xD;
      tooth and to prevent root canal treatment. A material has been introduced to the market for&#xD;
      this purpose, called Biodentine. This study aims to investigate the nerve response to this&#xD;
      material and to assess the quality of the overlying filling compared to another material&#xD;
      (glass ionomer cement) used more commonly. Also, X-rays are a routine procedure used to&#xD;
      assess how close the decay is to the nerve and to see if there are abnormalities around the&#xD;
      tooth. However conventional X-rays may not be accurate. A new technique called Cone Beam&#xD;
      Computed Tomography (CBCT) has been developed which shows a 3-D image of the tooth and may be&#xD;
      more accurate. We aim to compare the images gained from conventional X-rays and CBCT to help&#xD;
      improve diagnosis and care planning for patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The principal outcome of the study is whether the tooth restored with the test or control material remains vital (alive) at follow-up examination.</measure>
    <time_frame>up to 2 years</time_frame>
    <description>The vitality of the restored tooth (whether the nerve of the tooth is alive or dead) is determined clinically by a positive response to cold test, absence of spontaneous pain, negative sensitivity to percussion, absence of sinus/fistula/swelling and abnormal mobility, and absence/reduction of periapical radiolucencies as determined by PA radiographs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The integrity of the composite restoration overlying the test or control material is either acceptable or not.</measure>
    <time_frame>up to 2 years</time_frame>
    <description>As assessed clinically by USPHS criteria and Hickel's criteria for the assessment of dental restorations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The CBCT scans of the teeth restored with the test or control material are either more effective or are comparable to conventional radiographs in detecting the presence of early peri-radicular lesions associated with the restored teeth.</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Reversible Pulpitis</condition>
  <arm_group>
    <arm_group_label>calcium silicate cement (Biodentine™)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cone Beam computed tomography (CBCT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CBCT scans are taken to assess the efficacy of this method in detecting the presence of early peri-radicular lesions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Periapical radiographs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Periapical radiographs are taken as a control to detect the presence of early peri-radicular lesions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glass ionomer cement ( Fuji IX™)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Glass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Cone Beam computed tomography (Morita Accuitomo)</intervention_name>
    <description>CBCT scans are taken to assess the efficacy of this method in detecting the presence of early peri-radicular lesions.</description>
    <arm_group_label>Cone Beam computed tomography (CBCT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Periapical radiographs</intervention_name>
    <description>Periapical radiographs are taken as a control to detect the presence of early peri-radicular lesions.</description>
    <arm_group_label>Periapical radiographs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>calcium silicate cement (Biodentine™)</intervention_name>
    <description>calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.</description>
    <arm_group_label>calcium silicate cement (Biodentine™)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>glass ionomer cement ( Fuji IX™)</intervention_name>
    <description>glass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulp.</description>
    <arm_group_label>Glass ionomer cement ( Fuji IX™)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients either male or female over the age of 16 (who can consent for themselves) in&#xD;
             good general health&#xD;
&#xD;
          2. A minimum of one carious lesion (occlusal, proximal, or MOD)&#xD;
&#xD;
          3. Positive pulp response to electric pulp test and thermal stimulation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with clinical symptoms of irreversible pulpitis who need root canal treatment&#xD;
&#xD;
          2. The presence of fistulas or swelling&#xD;
&#xD;
          3. Anterior teeth with aesthetic concerns&#xD;
&#xD;
          4. External or internal root resorption&#xD;
&#xD;
          5. Multiple teeth with carious lesions in the same quadrant,&#xD;
&#xD;
          6. Mobile teeth or tenderness to percussion.&#xD;
&#xD;
          7. Pregnant women, in view of requirements for radiographs.&#xD;
&#xD;
          8. Patients younger than 16.&#xD;
&#xD;
          9. Patients unable to give consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Timothy F Watson, BDS,MSc,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King's College Dental Institute at Guy's Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>March 1, 2017</last_update_submitted>
  <last_update_submitted_qc>March 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Indirect pulp capping</keyword>
  <keyword>reversible pulpitis</keyword>
  <keyword>periapical radiolucency</keyword>
  <keyword>periapical radiographs</keyword>
  <keyword>cone beam computed tomography</keyword>
  <keyword>calcium silicate cements</keyword>
  <keyword>glass ionomer cements</keyword>
  <keyword>caries</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulpitis</mesh_term>
  </condition_browse>
  <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>
  </patient_data>
  <!-- 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/NCT02201641
org study id: 11-LO-1893
nct id: NCT02201641
lead sponsor: 
has dmc: Yes
This study aims to investigate the tooth nerve response to a recently introduced therapeutic
      filling material (calcium silicate cement) called Biodentine and to assess the quality of the
      overlying filling compared to another material (glass ionomer cement) called Fuji IX used
      more commonly. Also to compare the effectiveness of cone beam computed tomography x-rays
      compared to conventional periapical x-rays in detecting lesions around these teeth.
Tooth decay is one of the most widespread diseases in the world. Very often, a patient comes
      to the dental clinic when experiencing pain which commonly means the decay is deep and is
      very close to or has penetrated the nerve of the tooth. When the decay is very close to the
      pulp or nerve of the tooth, a procedure called pulp capping is done in an attempt to save the
      tooth and to prevent root canal treatment. A material has been introduced to the market for
      this purpose, called Biodentine. This study aims to investigate the nerve response to this
      material and to assess the quality of the overlying filling compared to another material
      (glass ionomer cement) used more commonly. Also, X-rays are a routine procedure used to
      assess how close the decay is to the nerve and to see if there are abnormalities around the
      tooth. However conventional X-rays may not be accurate. A new technique called Cone Beam
      Computed Tomography (CBCT) has been developed which shows a 3-D image of the tooth and may be
      more accurate. We aim to compare the images gained from conventional X-rays and CBCT to help
      improve diagnosis and care planning for patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The principal outcome of the study is whether the tooth restored with the test or control material remains vital (alive) at follow-up examination.
time frame: up to 2 years
description: The vitality of the restored tooth (whether the nerve of the tooth is alive or dead) is determined clinically by a positive response to cold test, absence of spontaneous pain, negative sensitivity to percussion, absence of sinus/fistula/swelling and abnormal mobility, and absence/reduction of periapical radiolucencies as determined by PA radiographs.
measure: The integrity of the composite restoration overlying the test or control material is either acceptable or not.
time frame: up to 2 years
description: As assessed clinically by USPHS criteria and Hickel's criteria for the assessment of dental restorations.
measure: The CBCT scans of the teeth restored with the test or control material are either more effective or are comparable to conventional radiographs in detecting the presence of early peri-radicular lesions associated with the restored teeth.
time frame: One year
arm group label: calcium silicate cement (Biodentine™)
arm group type: Experimental
description: calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.
arm group label: Cone Beam computed tomography (CBCT)
arm group type: Experimental
description: CBCT scans are taken to assess the efficacy of this method in detecting the presence of early peri-radicular lesions.
arm group label: Periapical radiographs
arm group type: Active Comparator
description: Periapical radiographs are taken as a control to detect the presence of early peri-radicular lesions.
arm group label: Glass ionomer cement ( Fuji IX™)
arm group type: Active Comparator
description: Glass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.
intervention type: Radiation
intervention name: Cone Beam computed tomography (Morita Accuitomo)
description: CBCT scans are taken to assess the efficacy of this method in detecting the presence of early peri-radicular lesions.
arm group label: Cone Beam computed tomography (CBCT)
intervention type: Radiation
intervention name: Periapical radiographs
description: Periapical radiographs are taken as a control to detect the presence of early peri-radicular lesions.
arm group label: Periapical radiographs
intervention type: Device
intervention name: calcium silicate cement (Biodentine™)
description: calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.
arm group label: calcium silicate cement (Biodentine™)
intervention type: Device
intervention name: glass ionomer cement ( Fuji IX™)
description: glass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulp.
arm group label: Glass ionomer cement ( Fuji IX™)
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Timothy F Watson, BDS,MSc,PhD
role: Study Chair
affiliation: King's College London
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Pulpitis
mesh term: Calcium
sharing ipd: No