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/NCT06002698</url>
    </required_header>
    <id_info>
      <org_study_id>DF RD2309/0068 (L)</org_study_id>
      <nct_id>NCT06002698</nct_id>
    </id_info>
    <brief_title>Full Pulpotomy Versus Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis</brief_title>
    <official_title>Full Pulpotomy Versus Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis: A Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Malaya</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Malaya</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background The European Society of Endodontology (ESE) and the American Association of&#xD;
        Endodontists (AAE) position statements on the management of deep caries and exposed pulp&#xD;
        recommended adoption and promotion of strategies aimed at preserving the pulp, but also&#xD;
        acknowledged the need for well-designed and adequately powered randomised control trials to&#xD;
        provide the evidence needed to support vital pulp treatment (VPT) and change clinical&#xD;
        practice.&#xD;
  &#xD;
        Objectives&#xD;
  &#xD;
          1. To undertake a randomised controlled clinical trial comparing full pulpotomy with root&#xD;
             canal treatment for mature maxillary and mandibular posterior teeth with signs and&#xD;
             symptoms indicative of irreversible pulpitis and normal apical tissues in adults.&#xD;
  &#xD;
          2. Undertake a cost-effectiveness analysis to examine the potential long-term costs and&#xD;
             benefits of pulpotomy.&#xD;
  &#xD;
          3. Undertake a process evaluation to assess the acceptability of the intervention to both&#xD;
             dentists and patients, while exploring the barriers and enablers to implementation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 8, 2023</start_date>
    <completion_date type="Anticipated">March 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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical Data</measure>
      <time_frame>6 months, 1 year and 2 years</time_frame>
      <description>(1) Clinical data: absence of pain, tenderness to palpation, presence of swelling, presence of sinus tract, pathological mobility, response to sensibility testing. Patient history taking and clinical examination for symptoms and clinical signs of infection such as swelling, and sinus tract will be performed by a blinded dental practitioner.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Radiographic data</measure>
      <time_frame>6 months, 1 year and 2 years</time_frame>
      <description>(2) Radiographic data: presence of periapical radiolucency, presence of inter-radicular radiolucency, presence of resorption, presence of calcifications. An independent assessor will assess the radiograph obtained at the 12-month review visit.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Post-operative pain</measure>
      <time_frame>Day 3 and Day 7</time_frame>
      <description>(1) Postoperative pain will be recorded by patients on day 3 and 7. Pain will be assessed using a numeric rating scale (NRS). NRS is an 11-point numeric scale with 0 representing &quot;no pain&quot; and 10 representing &quot;pain as bad as you can imagine&quot;. Patients will be instructed on how to use the NRS-11 at home on days 3 and 7 after the procedure. Patients will be contacted by phone call or text message to collect their responses.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Structural integrity assessment</measure>
      <time_frame>6 months, 1 year and 2 years</time_frame>
      <description>(2) Structural integrity of the tooth will be assessed by a blinded dental practitioner at the 12-month visit using World Dental Federation (FDI) criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evidence of further interventions and adverse effects</measure>
      <time_frame>6 months, 1 year and 2 years</time_frame>
      <description>Evidence of further interventions and adverse events will be obtained from patient records following the 12-month review visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Data for cost effective analysis</measure>
      <time_frame>Baseline, 6 months, 1 year and 2 years</time_frame>
      <description>Data for cost effective analysis and process evaluation will be collected.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Pulpitis - Irreversible</condition>
    <arm_group>
      <arm_group_label>Root canal treatment (Control)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The procedure can be carried out in single or two visits. Variations in root canal treatment protocols however will make it difficult to compare with pulpotomy so the aim is to standardize the protocols for the following variables including use of rubber dam, Irrigation protocol with 2-2.5% sodium hypochlorite; working length with combined radiographs and apex locators, automated instrumentation to accompany hand instrumentation and preparation to apical size 2-3 larger than the initial binding file. Canal to be medicated with non-setting calcium hydroxide if done in two visits and root canal filling with gutta percha and traditional sealers (warm or cold lateral condensation) and good coronal seal.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Full pulpotomy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The clinical procedure will be completed over one or two visits. Following adequate anesthesia and isolation with rubber dam, access to the pulp will be gained following caries removal to de-roof the pulp chamber and excision of the entire coronal pulp. The pulp chamber is irrigated with 2% sodium hypochlorite solution and the resultant bleeding from the remaining pulp will be controlled with a cotton pellet soaked in 2% sodium hypochlorite solution. Following complete haemostasis, the pulp stump will then be covered with Biodentine (Septodont Ltd., Saint Maur des Fausse ́s, France) and the tooth permanently restored with a restoration if treatment is completed in single visit or temporized with glass ionomer cement for the final restoration to be placed in the 2nd visit if operator opted for 2-visit treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Root canal treatment (Control)</intervention_name>
      <description>Root canal treatment - Removal of the inflamed pulp tissues from the whole root canals of the tooth.</description>
      <arm_group_label>Root canal treatment (Control)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Full pulpotomy (Experimental)</intervention_name>
      <description>Full pulpotomy - Removal of the inflamed coronal pulp tissues from the crown of the tooth.</description>
      <arm_group_label>Full pulpotomy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 12 years or older (with a mature permanent tooth demonstrating&#xD;
               radiographic evidence of a deep caries/restorations and signs/ symptoms indicative of&#xD;
               IRP (moderate to severe spontaneous lingering pain). Tooth will be responsive to cold&#xD;
               and EPT sensibility testing, restorable and can be adequately isolated during&#xD;
               treatment. One posterior tooth (molar or premolar) only per patient.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Teeth with active periodontal disease (pocket depth &gt;5mm); teeth indicated for&#xD;
               elective root canal treatment for restorative purposes, teeth with apical&#xD;
               periodontitis, patients with complex medical histories that may affect their caries&#xD;
               experience and healing ability (immunocompromised, radiotherapy), patients who are&#xD;
               unable to consent; history of previous trauma to the tooth, presence of apical&#xD;
               radiolucency and patients who are pregnant or breast-feeding. Intraoperatively, any&#xD;
               evidence of purulence or excessive bleeding that cannot be controlled with a cotton&#xD;
               pellet with 2-4% hypochlorite for 10 minutes will be excluded.&#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>Hany Ahmed, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Malaya</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hany Ahmed, PhD</last_name>
      <phone>0060129857937</phone>
      <email>hanyendodontist@um.edu.my</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hany Mohamed Aly Ahmed</name>
        <address>
          <city>Kuala Lumpur</city>
          <zip>50603</zip>
          <country>Malaysia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hany MA Ahmed</last_name>
        <phone>0060129857937</phone>
        <email>hanyendodontist@um.edu.my</email>
      </contact>
      <investigator>
        <last_name>Foo K Room</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nora Sakina M Noor</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Noor Hayati Azami</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hany MA Ahmed</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Malaysia</country>
    </location_countries>
    <reference>
      <citation>European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.</citation>
      <PMID>30664240</PMID>
    </reference>
    <reference>
      <citation>AAE Position Statement on Vital Pulp Therapy. J Endod. 2021 Sep;47(9):1340-1344. doi: 10.1016/j.joen.2021.07.015. Epub 2021 Aug 3. No abstract available.</citation>
      <PMID>34352305</PMID>
    </reference>
    <reference>
      <citation>Taha NA, Abuzaid AM, Khader YS. A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction. J Endod. 2023 Jun;49(6):624-631.e2. doi: 10.1016/j.joen.2023.04.001. Epub 2023 Apr 19.</citation>
      <PMID>37080387</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Malaya</investigator_affiliation>
      <investigator_full_name>Assoc. Prof. Dr. Hany Mohamed Aly Ahmed</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <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>
      <ipd_description>There is no plan to share the IPD.</ipd_description>
    </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/NCT06002698
  org study id: DF RD2309/0068 (L)
  nct id: NCT06002698
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Background The European Society of Endodontology (ESE) and the American Association of
        Endodontists (AAE) position statements on the management of deep caries and exposed pulp
        recommended adoption and promotion of strategies aimed at preserving the pulp, but also
        acknowledged the need for well-designed and adequately powered randomised control trials to
        provide the evidence needed to support vital pulp treatment (VPT) and change clinical
        practice.
  
        Objectives
  
          1. To undertake a randomised controlled clinical trial comparing full pulpotomy with root
             canal treatment for mature maxillary and mandibular posterior teeth with signs and
             symptoms indicative of irreversible pulpitis and normal apical tissues in adults.
  
          2. Undertake a cost-effectiveness analysis to examine the potential long-term costs and
             benefits of pulpotomy.
  
          3. Undertake a process evaluation to assess the acceptability of the intervention to both
             dentists and patients, while exploring the barriers and enablers to implementation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Clinical Data
  time frame: 6 months, 1 year and 2 years
  description: (1) Clinical data: absence of pain, tenderness to palpation, presence of swelling, presence of sinus tract, pathological mobility, response to sensibility testing. Patient history taking and clinical examination for symptoms and clinical signs of infection such as swelling, and sinus tract will be performed by a blinded dental practitioner.
  measure: Radiographic data
  time frame: 6 months, 1 year and 2 years
  description: (2) Radiographic data: presence of periapical radiolucency, presence of inter-radicular radiolucency, presence of resorption, presence of calcifications. An independent assessor will assess the radiograph obtained at the 12-month review visit.
  measure: Post-operative pain
  time frame: Day 3 and Day 7
  description: (1) Postoperative pain will be recorded by patients on day 3 and 7. Pain will be assessed using a numeric rating scale (NRS). NRS is an 11-point numeric scale with 0 representing "no pain" and 10 representing "pain as bad as you can imagine". Patients will be instructed on how to use the NRS-11 at home on days 3 and 7 after the procedure. Patients will be contacted by phone call or text message to collect their responses.
  measure: Structural integrity assessment
  time frame: 6 months, 1 year and 2 years
  description: (2) Structural integrity of the tooth will be assessed by a blinded dental practitioner at the 12-month visit using World Dental Federation (FDI) criteria
  measure: Evidence of further interventions and adverse effects
  time frame: 6 months, 1 year and 2 years
  description: Evidence of further interventions and adverse events will be obtained from patient records following the 12-month review visit.
  measure: Data for cost effective analysis
  time frame: Baseline, 6 months, 1 year and 2 years
  description: Data for cost effective analysis and process evaluation will be collected.
  arm group label: Root canal treatment (Control)
  arm group type: Other
  description: The procedure can be carried out in single or two visits. Variations in root canal treatment protocols however will make it difficult to compare with pulpotomy so the aim is to standardize the protocols for the following variables including use of rubber dam, Irrigation protocol with 2-2.5% sodium hypochlorite; working length with combined radiographs and apex locators, automated instrumentation to accompany hand instrumentation and preparation to apical size 2-3 larger than the initial binding file. Canal to be medicated with non-setting calcium hydroxide if done in two visits and root canal filling with gutta percha and traditional sealers (warm or cold lateral condensation) and good coronal seal.
  arm group label: Full pulpotomy
  arm group type: Experimental
  description: The clinical procedure will be completed over one or two visits. Following adequate anesthesia and isolation with rubber dam, access to the pulp will be gained following caries removal to de-roof the pulp chamber and excision of the entire coronal pulp. The pulp chamber is irrigated with 2% sodium hypochlorite solution and the resultant bleeding from the remaining pulp will be controlled with a cotton pellet soaked in 2% sodium hypochlorite solution. Following complete haemostasis, the pulp stump will then be covered with Biodentine (Septodont Ltd., Saint Maur des Fausse ́s, France) and the tooth permanently restored with a restoration if treatment is completed in single visit or temporized with glass ionomer cement for the final restoration to be placed in the 2nd visit if operator opted for 2-visit treatment.
  intervention type: Procedure
  intervention name: Root canal treatment (Control)
  description: Root canal treatment - Removal of the inflamed pulp tissues from the whole root canals of the tooth.
  arm group label: Root canal treatment (Control)
  intervention type: Procedure
  intervention name: Full pulpotomy (Experimental)
  description: Full pulpotomy - Removal of the inflamed coronal pulp tissues from the crown of the tooth.
  arm group label: Full pulpotomy
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hany Ahmed, PhD
  role: Principal Investigator
  affiliation: University Malaya
  last name: Hany Ahmed, PhD
  phone: 0060129857937
  email: hanyendodontist@um.edu.my
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Malaysia
  citation: European Society of Endodontology (ESE) developed by:; Duncan HF, Galler KM, Tomson PL, Simon S, El-Karim I, Kundzina R, Krastl G, Dammaschke T, Fransson H, Markvart M, Zehnder M, Bjorndal L. European Society of Endodontology position statement: Management of deep caries and the exposed pulp. Int Endod J. 2019 Jul;52(7):923-934. doi: 10.1111/iej.13080.
  PMID: 30664240
  citation: AAE Position Statement on Vital Pulp Therapy. J Endod. 2021 Sep;47(9):1340-1344. doi: 10.1016/j.joen.2021.07.015. Epub 2021 Aug 3. No abstract available.
  PMID: 34352305
  citation: Taha NA, Abuzaid AM, Khader YS. A Randomized Controlled Clinical Trial of Pulpotomy versus Root Canal Therapy in Mature Teeth with Irreversible Pulpitis: Outcome, Quality of Life, and Patients' Satisfaction. J Endod. 2023 Jun;49(6):624-631.e2. doi: 10.1016/j.joen.2023.04.001. Epub 2023 Apr 19.
  PMID: 37080387
  responsible party type: Principal Investigator
  investigator affiliation: University of Malaya
  investigator full name: Assoc. Prof. Dr. Hany Mohamed Aly Ahmed
  investigator title: Associate Professor
  mesh term: Pulpitis
  sharing ipd: No
  ipd description: There is no plan to share the IPD.