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/NCT05964933</url>
    </required_header>
    <id_info>
      <org_study_id>DSRB 2023/00044</org_study_id>
      <nct_id>NCT05964933</nct_id>
    </id_info>
    <brief_title>Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis</brief_title>
    <official_title>Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis</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>Yes</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>
        This study is a randomised controlled trial for complete pulpotomy as an alternative to root&#xD;
        canal treatment for teeth with clinical diagnosis of symptomatic irreversible pulpitis (i.e.&#xD;
        signs and symptoms indicative of irreversible pulpitis) conducted at the National University&#xD;
        Centre for Oral Health Singapore (NUCOHS) Endodontic unit. Up to 70 teeth, 35 in each group,&#xD;
        will be enrolled.&#xD;
  &#xD;
        Clinical and radiographic outcome data will be collected and analysed, and a parallel&#xD;
        cost-effectiveness analysis will also be undertaken to examine the potential costs and&#xD;
        benefits of pulpotomy. A process evaluation will also be conducted to assess the&#xD;
        acceptability of the intervention to both dentists and patients, while exploring the barriers&#xD;
        and enablers to implementation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Mature permanent teeth with deep caries/restorations and symptoms indicative of irreversible&#xD;
        pulpitis (moderate to severe spontaneous lingering pain) will be included in the study. The&#xD;
        teeth will be randomised to receive one of two treatments: RCT or complete pulpotomy (n=35 in&#xD;
        each group).&#xD;
  &#xD;
        Baseline clinical and radiographic data will be collected at the first visit. In addition,&#xD;
        patients (or their guardians, if relevant) will be invited to complete the acceptability and&#xD;
        willingness to pay questionnaires for health economics analysis at both the first visit and&#xD;
        at 12 months from the date of completed treatment. Pain data will be collected via a pain&#xD;
        diary after completion of treatment at days 3 and 7 post-treatment. Patients will be&#xD;
        clinically and radiographically reviewed at 6 and 12 months from the date of completed&#xD;
        treatment. Review clinical data collected will include the absence of pain (and details on&#xD;
        the nature of pain, if relevant), tenderness to percussion and palpation, presence of a&#xD;
        swelling or a sinus tract, pathological mobility, structural integrity of tooth, intact and&#xD;
        non-defective restoration, and response to electric pulp testing (for the pulpotomy group&#xD;
        only). Radiographic data collected will include the presence of periapical radiolucency,&#xD;
        presence of inter-radicular radiolucency, presence of resorption, and presence of&#xD;
        calcifications. The need for any further intervention (including details of any procedure) or&#xD;
        any adverse events or unscheduled visits over the follow-up period will also be recorded.&#xD;
  &#xD;
        Success will be defined as 1) the absence of pain indicative of irreversible pulpitis, 2) the&#xD;
        absence of signs and symptoms indicative of acute or chronic periapical disease, and 3) the&#xD;
        absence of radiographic evidence of failure including radiolucency or resorption. SPSS&#xD;
        Statistical Package (IBM SPSS Statistics) will be used for all statistical analysis, with the&#xD;
        significance level for all statistical tests set at p-value&lt;0.05.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">July 11, 2023</start_date>
    <completion_date type="Anticipated">December 2027</completion_date>
    <primary_completion_date type="Anticipated">December 2026</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>
      <intervention_model_description>Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Blinding will be done to the outcomes assessors to reduce bias during radiographic healing assessment. Participants also will not be informed of which treatment they are undergoing.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Composite measure is defined by the change from baseline pain and radiographic status at 6 months and again at 12 months.</measure>
      <time_frame>6, 12 months</time_frame>
      <description>Composite measure defined as:&#xD;
  absence of pain indicative of irreversible pulpitis;&#xD;
  absence of signs and symptoms indicative of acute or chronic periapical disease;&#xD;
  absence of radiographic evidence of failure including radiolucency or resorption.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Numeric Rate Scale (NRS): minimum value = 0 (best outcome), maximum value = 10 (worst outcome)</measure>
      <time_frame>3, 7 days</time_frame>
      <description>A patient reported outcome of pain experienced and use of analgesia in the immediate post-operative period, collected through a Numeric Rating Scale (NRS).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Restoration: the restoration remains intact and adapts completely to the prepared cavity margins.</measure>
      <time_frame>6, 12 months</time_frame>
      <description>The presence of a structurally integral tooth with an intact, non-defective restoration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>A &quot;yes&quot; or &quot;no&quot; response when the Cold Test and Electric Pulp Test are applied on the treated tooth.</measure>
      <time_frame>6, 12 months</time_frame>
      <description>Positive sensibility response on electrical pulp test (EPT) for the Pulpotomy group only.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>N5. Clinicians examine the treated tooth to determine if there is pathology that resulted from the treatment.</measure>
      <time_frame>12 months</time_frame>
      <description>Absence of need for any further intervention during the follow-up period or any adverse event.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Data to be collected include time spent on receiving the treatment, cost of treatment, and patients' willingness to pay for treatment.</measure>
      <time_frame>12 months</time_frame>
      <description>A parallel process evaluation and health economics analysis will be completed using data collected from participants at baseline and at 12 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Radiographic appearance of the dental pulp and its canal(s) at baseline will be compared to that at 12 months.</measure>
      <time_frame>12, months</time_frame>
      <description>Radiographic evidence of pulp calcification in response to Pulpotomy (applicable to the Pulpotomy group only).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Pulpitis - Irreversible</condition>
    <arm_group>
      <arm_group_label>Complete Pulpotomy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The tooth will be treated with Complete Pulpotomy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pulpectomy and Root Canal Treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The tooth will be treated with Pulpectomy and Root Canal Treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Complete Pulpotomy</intervention_name>
      <description>Complete caries removal and excision of the entire coronal pulp to the level of the root canal orifices will be performed. After haemostasis, the pulp chamber will be filled with Biodentine® and a final direct restoration placed in 1 or 2 visits.&#xD;
  If there is no bleeding from the exposed pulp, pulpectomy and root canal treatment will be performed instead, and the patient will be excluded from the study.</description>
      <arm_group_label>Complete Pulpotomy</arm_group_label>
      <other_name>Full Pulpotomy</other_name>
      <other_name>Coronal Pulpotomy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Pulpectomy and Root Canal Treatment</intervention_name>
      <description>After complete caries removal and pulp exposure, Pulpectomy will be performed to remove all pulp tissues. Conventional root canal treatment will be performed using rotary instrumentation followed by obturation with gutta percha and traditional sealers in 1 or 2 visits. A final restoration will be placed to ensure a good coronal seal, and this may include full coronal coverage restorations if clinically indicated.</description>
      <arm_group_label>Pulpectomy and Root Canal Treatment</arm_group_label>
      <other_name>Conventional Root Canal Treatment</other_name>
      <other_name>Non-surgical Endodontic Treatment</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 12 years or older&#xD;
  &#xD;
            -  Mature permanent tooth with deep caries/restorations&#xD;
  &#xD;
            -  Symptoms indicative of irreversible pulpitis (moderate to severe spontaneous lingering&#xD;
               pain)&#xD;
  &#xD;
            -  Tooth is responsive to cold and electric pulp test (EPT) sensibility testing&#xD;
  &#xD;
            -  Tooth is restorable and can be adequately isolated during treatment&#xD;
  &#xD;
            -  One tooth (molar or premolar) per patient.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Teeth with active periodontal disease (pocket depth &gt;5mm)&#xD;
  &#xD;
            -  Teeth indicated for elective root canal treatment for restorative purposes&#xD;
  &#xD;
            -  Teeth with apical periodontitis&#xD;
  &#xD;
            -  Patients with complex medical histories that may affect their caries experience and&#xD;
               healing ability (immunocompromised, radiotherapy etc.)&#xD;
  &#xD;
            -  Patients who are unable to consent&#xD;
  &#xD;
            -  History of trauma to the tooth&#xD;
  &#xD;
            -  Presence of apical radiolucency&#xD;
  &#xD;
            -  Patients who are pregnant or breast-feeding&#xD;
  &#xD;
            -  Teeth with any evidence of purulence or excessive bleeding that cannot be controlled&#xD;
               with a cotton pellet with 2-4% hypochlorite for 10 minutes&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Victoria Yu, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National University Hosptial, Singapore</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National University Hospital, Singapore</name>
        <address>
          <city>Singapore</city>
          <zip>119074</zip>
          <country>Singapore</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Singapore</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>dental caries</keyword>
    <keyword>deep caries</keyword>
    <keyword>pulpotomy</keyword>
    <keyword>root canal treatment</keyword>
    <keyword>vital pulp therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulpitis</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/NCT05964933
  org study id: DSRB 2023/00044
  nct id: NCT05964933
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is a randomised controlled trial for complete pulpotomy as an alternative to root
        canal treatment for teeth with clinical diagnosis of symptomatic irreversible pulpitis (i.e.
        signs and symptoms indicative of irreversible pulpitis) conducted at the National University
        Centre for Oral Health Singapore (NUCOHS) Endodontic unit. Up to 70 teeth, 35 in each group,
        will be enrolled.
  
        Clinical and radiographic outcome data will be collected and analysed, and a parallel
        cost-effectiveness analysis will also be undertaken to examine the potential costs and
        benefits of pulpotomy. A process evaluation will also be conducted to assess the
        acceptability of the intervention to both dentists and patients, while exploring the barriers
        and enablers to implementation.
  Mature permanent teeth with deep caries/restorations and symptoms indicative of irreversible
        pulpitis (moderate to severe spontaneous lingering pain) will be included in the study. The
        teeth will be randomised to receive one of two treatments: RCT or complete pulpotomy (n=35 in
        each group).
  
        Baseline clinical and radiographic data will be collected at the first visit. In addition,
        patients (or their guardians, if relevant) will be invited to complete the acceptability and
        willingness to pay questionnaires for health economics analysis at both the first visit and
        at 12 months from the date of completed treatment. Pain data will be collected via a pain
        diary after completion of treatment at days 3 and 7 post-treatment. Patients will be
        clinically and radiographically reviewed at 6 and 12 months from the date of completed
        treatment. Review clinical data collected will include the absence of pain (and details on
        the nature of pain, if relevant), tenderness to percussion and palpation, presence of a
        swelling or a sinus tract, pathological mobility, structural integrity of tooth, intact and
        non-defective restoration, and response to electric pulp testing (for the pulpotomy group
        only). Radiographic data collected will include the presence of periapical radiolucency,
        presence of inter-radicular radiolucency, presence of resorption, and presence of
        calcifications. The need for any further intervention (including details of any procedure) or
        any adverse events or unscheduled visits over the follow-up period will also be recorded.
  
        Success will be defined as 1) the absence of pain indicative of irreversible pulpitis, 2) the
        absence of signs and symptoms indicative of acute or chronic periapical disease, and 3) the
        absence of radiographic evidence of failure including radiolucency or resorption. SPSS
        Statistical Package (IBM SPSS Statistics) will be used for all statistical analysis, with the
        significance level for all statistical tests set at p-value<0.05.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Blinding will be done to the outcomes assessors to reduce bias during radiographic healing assessment. Participants also will not be informed of which treatment they are undergoing.
  measure: Composite measure is defined by the change from baseline pain and radiographic status at 6 months and again at 12 months.
  time frame: 6, 12 months
  description: Composite measure defined as:
  absence of pain indicative of irreversible pulpitis;
  absence of signs and symptoms indicative of acute or chronic periapical disease;
  absence of radiographic evidence of failure including radiolucency or resorption.
  measure: Numeric Rate Scale (NRS): minimum value = 0 (best outcome), maximum value = 10 (worst outcome)
  time frame: 3, 7 days
  description: A patient reported outcome of pain experienced and use of analgesia in the immediate post-operative period, collected through a Numeric Rating Scale (NRS).
  measure: Restoration: the restoration remains intact and adapts completely to the prepared cavity margins.
  time frame: 6, 12 months
  description: The presence of a structurally integral tooth with an intact, non-defective restoration.
  measure: A "yes" or "no" response when the Cold Test and Electric Pulp Test are applied on the treated tooth.
  time frame: 6, 12 months
  description: Positive sensibility response on electrical pulp test (EPT) for the Pulpotomy group only.
  measure: N5. Clinicians examine the treated tooth to determine if there is pathology that resulted from the treatment.
  time frame: 12 months
  description: Absence of need for any further intervention during the follow-up period or any adverse event.
  measure: Data to be collected include time spent on receiving the treatment, cost of treatment, and patients' willingness to pay for treatment.
  time frame: 12 months
  description: A parallel process evaluation and health economics analysis will be completed using data collected from participants at baseline and at 12 months.
  measure: Radiographic appearance of the dental pulp and its canal(s) at baseline will be compared to that at 12 months.
  time frame: 12, months
  description: Radiographic evidence of pulp calcification in response to Pulpotomy (applicable to the Pulpotomy group only).
  arm group label: Complete Pulpotomy
  arm group type: Active Comparator
  description: The tooth will be treated with Complete Pulpotomy.
  arm group label: Pulpectomy and Root Canal Treatment
  arm group type: Active Comparator
  description: The tooth will be treated with Pulpectomy and Root Canal Treatment.
  intervention type: Procedure
  intervention name: Complete Pulpotomy
  description: Complete caries removal and excision of the entire coronal pulp to the level of the root canal orifices will be performed. After haemostasis, the pulp chamber will be filled with Biodentine® and a final direct restoration placed in 1 or 2 visits.
  If there is no bleeding from the exposed pulp, pulpectomy and root canal treatment will be performed instead, and the patient will be excluded from the study.
  arm group label: Complete Pulpotomy
  other name: Full Pulpotomy
  other name: Coronal Pulpotomy
  intervention type: Procedure
  intervention name: Pulpectomy and Root Canal Treatment
  description: After complete caries removal and pulp exposure, Pulpectomy will be performed to remove all pulp tissues. Conventional root canal treatment will be performed using rotary instrumentation followed by obturation with gutta percha and traditional sealers in 1 or 2 visits. A final restoration will be placed to ensure a good coronal seal, and this may include full coronal coverage restorations if clinically indicated.
  arm group label: Pulpectomy and Root Canal Treatment
  other name: Conventional Root Canal Treatment
  other name: Non-surgical Endodontic Treatment
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Victoria Yu, PhD
  role: Principal Investigator
  affiliation: National University Hosptial, Singapore
  facility: 
  country: Singapore
  responsible party type: Sponsor
  mesh term: Pulpitis
  sharing ipd: No