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/NCT06029023</url>
    </required_header>
    <id_info>
      <org_study_id>october 6 university</org_study_id>
      <nct_id>NCT06029023</nct_id>
    </id_info>
    <brief_title>Clinical And Radiographic Evaluation Of Nano-Propolis, Nano-Curcumin and MTA as Direct Pulp Capping Agents in Young Permanant Teeth</brief_title>
    <official_title>Clinical And Radiographic Evaluation of Nano-Propolis, Nano-Curcumin and MTA as Direct Pulp Capping Agents in Young Permanant Teeth</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Azhar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>October 6 University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Al-Azhar University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study is to evaluate clinical and radiographic effect of nano propolis and&#xD;
        nano curcumin as direct pulp capping agents in young permanent teeth.&#xD;
  &#xD;
        .&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        I. Materials:&#xD;
  &#xD;
          1. Mineral trioxide aggregate (MTA)&#xD;
  &#xD;
          2. Nano propolis&#xD;
  &#xD;
          3. Nano curcumin&#xD;
  &#xD;
          4. Glass ionomer&#xD;
  &#xD;
        II. Methods:&#xD;
  &#xD;
        Sample size calculation:&#xD;
  &#xD;
        Sample size calculation was performed using G*Power version 3.1.9.7 based on the results of a&#xD;
        previous study. The predicted sample size (n) was (54), i.e., 18 samples per group of the&#xD;
        three groups, to detect results of dentin bridge thickness.&#xD;
  &#xD;
        Sample preparation:&#xD;
  &#xD;
        Patients will be recruited from the department of Pediatric Dentistry and Dental Public&#xD;
        Heath, October 6 university. The study sample will be recruited among the children between 7&#xD;
        to 13 years old. The young permanent tooth eruption stage will be determined by the patient's&#xD;
        age and radiographic evaluation before enrolling in the research study.&#xD;
  &#xD;
        Before treatment, a periapical radiograph will be taken with ultra-low dose mode to assess&#xD;
        the tooth radiographically for any sign of irreversible pulpitis.&#xD;
  &#xD;
        Each tooth will be infiltrated with local anesthesia using 4% articaine with 1:100,000&#xD;
        epinephrine (Septanest, Septodont, France). The tooth will be isolated with a rubber dam and&#xD;
        washed with 0.12% chlorhexidine. The cavity will be prepared, and the infected enamel and&#xD;
        dentin will be removed with a round bur. The carious dentin close to the pulp will be removed&#xD;
        using a spoon excavator. The pulp exposure position will be identified, and the inflamed pulp&#xD;
        tissue (1.5-2 mm) will be gently removed using an abrasive diamond bur at high speed with&#xD;
        copious sterilized normal saline. The remaining healthy pulp will be rinsed with 2.5% sodium&#xD;
        hypochlorite, and moist, sterilized cotton pellets will be placed over the pulp stumps with&#xD;
        light pressure for 2 min to achieve hemostasis. If the bleeding could not be controlled, the&#xD;
        tooth will be excluded from this study. MTA or nano propolis or nano curcumin will then be&#xD;
        placed over the remaining healthy pulp per the manufacturer's recommendation. To cover the&#xD;
        exposure area, MTA and or nano propolis or nano curcumin will be placed using an amalgam&#xD;
        carrier and non-toothed Adson forceps, respectively. The cavities will be lined with glass&#xD;
        ionomer cement (Vitrebond, 3M ESPE, St. Paul, MN, USA), and a permanent composite restoration&#xD;
        (Filtex Z350, 3M ESPE, Salt Lake City, UT, USA) will be placed after 6 months. After&#xD;
        treatment, a periapical radiograph and CBCT (Planmeca. Romexis. Fenland) will be immediately&#xD;
        taken with ultra-low dose mode (90 kVp, 5.6 mA, 4 × 5 cm FOV, and 0.2 vowel size) to serve as&#xD;
        the baseline with a reduced dose, due to the need for future follow-ups.&#xD;
  &#xD;
        The CBCT will be performed using an ultralow dose, small field of view, and appropriate&#xD;
        radiation protection as described by the American Association of Endodontics (AAE) and the&#xD;
        American Academy of Oral and Maxillofacial Radiology (AAOMR), and the European Society of&#xD;
        Endodontology guidelines.&#xD;
  &#xD;
        Shielding devices, a leaded thyroid collar, leaded glasses, and a leaded apron, will be used&#xD;
        to protect the patient's thyroid gland, eye lens, body, respectively. The patients and their&#xD;
        parents will be interviewed by telephone on day 1 and day 7 post-surgery about any pain or&#xD;
        adverse reactions related to the treatment. Paracetamol will be prescribed if the patients&#xD;
        had pain, however, no antibiotic will be used following the surgery. The patients will&#xD;
        receive a 3-month follow-up clinical and periapical radiographic examination, together with 6&#xD;
        months clinical and CBCT examinations. The clinical and radiograph evaluations will be&#xD;
        performed by blinded experienced endodontist and radiologist. The examiners will be trained&#xD;
        in the evaluation criteria prior to the study. To determine the reliability of the&#xD;
        evaluations, Kappa scores will be determined by the 2 examiners re-evaluating all cases 1&#xD;
        month after the initial evaluation performed. The intra- and inter-examiner Kappa scores of&#xD;
        the clinical evaluation will be 1.0. For the radiographic evaluation, the intra-rater and&#xD;
        inter-rater reliabilities will be 0.91 and 0.89, respectively. When there will be a&#xD;
        disagreement, both examiners discussed the clinical and radiographic findings to achieve a&#xD;
        consensus.&#xD;
  &#xD;
        Variables:&#xD;
  &#xD;
        Table 1: variables of the study:&#xD;
  &#xD;
        Variables Referring to. Treatment agent MTA Nano propolis Nano curcumin&#xD;
  &#xD;
        Time of assessment 6 months&#xD;
  &#xD;
        Table 2: Interaction of variables of the study:&#xD;
  &#xD;
        Variables Test MTA Nano propolis Nano curcumin Total Clinical examination 18 18 18 54 Dentin&#xD;
        bridge formation. 18 18 18 54&#xD;
  &#xD;
        Statistical Analysis:&#xD;
  &#xD;
        All data will be collected, coded, tabulated and statistically analyzed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 20, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <phase>Phase 1</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>Supportive Care</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of pain or swelling</measure>
      <time_frame>1 week ,3 month , 6 month</time_frame>
      <description>questionnaire applied for patient</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>increase thickness of dentin bridge</measure>
      <time_frame>baseline ,6 month</time_frame>
      <description>digital cone beam radiograph</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Traumatic Pulp Exposure in Children</condition>
    <arm_group>
      <arm_group_label>MTA</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Mineral trioxide aggregate MTA, The cement is made up of calcium, silicon and aluminium. The main constituent phases are tricalcium and dicalcium silicate and tricalcium aluminate.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Nano propolis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Propolis is a resinous substance that honey bees collect from different plant species. The most important pharmacologically active constituents in propolis are flavonoids, phenolics, and aromatics.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Nano curcumin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Curcumin (CUR), 7-bis (4-hydroxy-3-methoxyphenyl)-1,6- heptadien-3, 5-dione</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>MTA Cement, propolis nano particle, curcumin nanoparticles</intervention_name>
      <description>MTA or nano propolis or nano curcumin will then be placed over the remaining healthy pulp per the manufacturer's recommendation. The cavities will be lined with glass ionomer cement and a permanent composite restoration will be placed after 6 months. After treatment, a periapical radiograph and CBCT will be immediately taken with ultra-low dose The patients and their parents will be interviewed by telephone on day 1 and day 7 post-surgery about any pain or adverse reactions related to the treatment. Paracetamol will be prescribed if the patients had pain, however, no antibiotic will be used following the surgery. The patients will receive a 3-month follow-up clinical and periapical radiographic examination, together with 6 months clinical and CBCT examinations.</description>
      <arm_group_label>MTA</arm_group_label>
      <arm_group_label>Nano curcumin</arm_group_label>
      <arm_group_label>Nano propolis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Young permanent teeth with deep carious lesions that led to a caries-exposed pulp&#xD;
               after spoon excavation and a diagnosis of reversible pulpitis.&#xD;
  &#xD;
            -  The tooth has a pulp exposure caused by trauma that occurred within 48 h.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The patient has a history of systemic disease that interferes with pulp healing.&#xD;
  &#xD;
            -  The tooth has clinical signs and symptoms of irreversible pulpitis, e.g., spontaneous&#xD;
               throbbing pain, tenderness to percussion, abnormal tooth mobility, swelling, or sinus&#xD;
               tract.&#xD;
  &#xD;
            -  Radiographic evidence of internal or external resorption, inter-radicular bone loss,&#xD;
               or periapical pathology.&#xD;
  &#xD;
            -  The tooth was non-restorable. During the study, if any symptoms of irreversible&#xD;
               pulpitis, apical periodontitis, or infection occurred, the patients received the&#xD;
               appropriate treatment following the institute protocol, including regenerative and&#xD;
               root canal treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>13 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Dalia Elasser</name>
        <address>
          <city>Cairo</city>
          <zip>11765</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>dalia elasser, PhD</last_name>
        <phone>+50021825</phone>
        <email>elasserd27@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Dina Abd Elghany, PhD</last_name>
        <phone>01229428323</phone>
        <email>drdinamohamed.dent@o6u.edu.eg</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 22, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Al-Azhar University</investigator_affiliation>
      <investigator_full_name>Dalia Mohamed Elasser</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>MTA</keyword>
    <keyword>PROPOLIS nano particles</keyword>
    <keyword>nanocurcumin</keyword>
    <keyword>dentin bridge</keyword>
    <keyword>CBCT</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Propolis</mesh_term>
      <mesh_term>Curcumin</mesh_term>
    </intervention_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/NCT06029023
  org study id: october 6 university
  nct id: NCT06029023
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The aim of the study is to evaluate clinical and radiographic effect of nano propolis and
        nano curcumin as direct pulp capping agents in young permanent teeth.
  
        .
  I. Materials:
  
          1. Mineral trioxide aggregate (MTA)
  
          2. Nano propolis
  
          3. Nano curcumin
  
          4. Glass ionomer
  
        II. Methods:
  
        Sample size calculation:
  
        Sample size calculation was performed using G*Power version 3.1.9.7 based on the results of a
        previous study. The predicted sample size (n) was (54), i.e., 18 samples per group of the
        three groups, to detect results of dentin bridge thickness.
  
        Sample preparation:
  
        Patients will be recruited from the department of Pediatric Dentistry and Dental Public
        Heath, October 6 university. The study sample will be recruited among the children between 7
        to 13 years old. The young permanent tooth eruption stage will be determined by the patient's
        age and radiographic evaluation before enrolling in the research study.
  
        Before treatment, a periapical radiograph will be taken with ultra-low dose mode to assess
        the tooth radiographically for any sign of irreversible pulpitis.
  
        Each tooth will be infiltrated with local anesthesia using 4% articaine with 1:100,000
        epinephrine (Septanest, Septodont, France). The tooth will be isolated with a rubber dam and
        washed with 0.12% chlorhexidine. The cavity will be prepared, and the infected enamel and
        dentin will be removed with a round bur. The carious dentin close to the pulp will be removed
        using a spoon excavator. The pulp exposure position will be identified, and the inflamed pulp
        tissue (1.5-2 mm) will be gently removed using an abrasive diamond bur at high speed with
        copious sterilized normal saline. The remaining healthy pulp will be rinsed with 2.5% sodium
        hypochlorite, and moist, sterilized cotton pellets will be placed over the pulp stumps with
        light pressure for 2 min to achieve hemostasis. If the bleeding could not be controlled, the
        tooth will be excluded from this study. MTA or nano propolis or nano curcumin will then be
        placed over the remaining healthy pulp per the manufacturer's recommendation. To cover the
        exposure area, MTA and or nano propolis or nano curcumin will be placed using an amalgam
        carrier and non-toothed Adson forceps, respectively. The cavities will be lined with glass
        ionomer cement (Vitrebond, 3M ESPE, St. Paul, MN, USA), and a permanent composite restoration
        (Filtex Z350, 3M ESPE, Salt Lake City, UT, USA) will be placed after 6 months. After
        treatment, a periapical radiograph and CBCT (Planmeca. Romexis. Fenland) will be immediately
        taken with ultra-low dose mode (90 kVp, 5.6 mA, 4 × 5 cm FOV, and 0.2 vowel size) to serve as
        the baseline with a reduced dose, due to the need for future follow-ups.
  
        The CBCT will be performed using an ultralow dose, small field of view, and appropriate
        radiation protection as described by the American Association of Endodontics (AAE) and the
        American Academy of Oral and Maxillofacial Radiology (AAOMR), and the European Society of
        Endodontology guidelines.
  
        Shielding devices, a leaded thyroid collar, leaded glasses, and a leaded apron, will be used
        to protect the patient's thyroid gland, eye lens, body, respectively. The patients and their
        parents will be interviewed by telephone on day 1 and day 7 post-surgery about any pain or
        adverse reactions related to the treatment. Paracetamol will be prescribed if the patients
        had pain, however, no antibiotic will be used following the surgery. The patients will
        receive a 3-month follow-up clinical and periapical radiographic examination, together with 6
        months clinical and CBCT examinations. The clinical and radiograph evaluations will be
        performed by blinded experienced endodontist and radiologist. The examiners will be trained
        in the evaluation criteria prior to the study. To determine the reliability of the
        evaluations, Kappa scores will be determined by the 2 examiners re-evaluating all cases 1
        month after the initial evaluation performed. The intra- and inter-examiner Kappa scores of
        the clinical evaluation will be 1.0. For the radiographic evaluation, the intra-rater and
        inter-rater reliabilities will be 0.91 and 0.89, respectively. When there will be a
        disagreement, both examiners discussed the clinical and radiographic findings to achieve a
        consensus.
  
        Variables:
  
        Table 1: variables of the study:
  
        Variables Referring to. Treatment agent MTA Nano propolis Nano curcumin
  
        Time of assessment 6 months
  
        Table 2: Interaction of variables of the study:
  
        Variables Test MTA Nano propolis Nano curcumin Total Clinical examination 18 18 18 54 Dentin
        bridge formation. 18 18 18 54
  
        Statistical Analysis:
  
        All data will be collected, coded, tabulated and statistically analyzed.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Incidence of pain or swelling
  time frame: 1 week ,3 month , 6 month
  description: questionnaire applied for patient
  measure: increase thickness of dentin bridge
  time frame: baseline ,6 month
  description: digital cone beam radiograph
  arm group label: MTA
  arm group type: Active Comparator
  description: Mineral trioxide aggregate MTA, The cement is made up of calcium, silicon and aluminium. The main constituent phases are tricalcium and dicalcium silicate and tricalcium aluminate.
  arm group label: Nano propolis
  arm group type: Experimental
  description: Propolis is a resinous substance that honey bees collect from different plant species. The most important pharmacologically active constituents in propolis are flavonoids, phenolics, and aromatics.
  arm group label: Nano curcumin
  arm group type: Experimental
  description: Curcumin (CUR), 7-bis (4-hydroxy-3-methoxyphenyl)-1,6- heptadien-3, 5-dione
  intervention type: Combination Product
  intervention name: MTA Cement, propolis nano particle, curcumin nanoparticles
  description: MTA or nano propolis or nano curcumin will then be placed over the remaining healthy pulp per the manufacturer's recommendation. The cavities will be lined with glass ionomer cement and a permanent composite restoration will be placed after 6 months. After treatment, a periapical radiograph and CBCT will be immediately taken with ultra-low dose The patients and their parents will be interviewed by telephone on day 1 and day 7 post-surgery about any pain or adverse reactions related to the treatment. Paracetamol will be prescribed if the patients had pain, however, no antibiotic will be used following the surgery. The patients will receive a 3-month follow-up clinical and periapical radiographic examination, together with 6 months clinical and CBCT examinations.
  arm group label: MTA
  arm group label: Nano curcumin
  arm group label: Nano propolis
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 13 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Al-Azhar University
  investigator full name: Dalia Mohamed Elasser
  investigator title: Principal Investigator
  mesh term: Propolis
  mesh term: Curcumin
  sharing ipd: No