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/NCT05983900</url>
    </required_header>
    <id_info>
      <org_study_id>9197358</org_study_id>
      <nct_id>NCT05983900</nct_id>
    </id_info>
    <brief_title>Clinical Evaluation and Antimicrobial Effect of Papain Based Chemo-mechanical Caries Removal Agents</brief_title>
    <official_title>Clinical Evaluation and Antimicrobial Effect of Papain Based Chemo-mechanical Caries Removal Agents in Young Permanent Molars (A Randomized Controlled Clinical Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria University</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>
        Minimally invasive dentistry continues to gain importance, especially in the treatment of&#xD;
        permanent teeth with deep caries lesions and immature roots. Chemo-mechanical caries removal&#xD;
        (CMCR) is an alternative to the conventional method and consists of the application of a&#xD;
        proteolytic substance that softens carious dentin tissue and facilitates its removal using&#xD;
        manual instruments. This method can be employed without the use of local anesthesia or burs,&#xD;
        thereby preserving sound dental tissue.&#xD;
  &#xD;
        The trial aim to assess the clinical performance of Brix 3ooo and Papacarie duo gel as&#xD;
        chemo-mechanical caries removal agents (CMCR), their performance in terms of time required&#xD;
        for the caries removal, patient subjective pain reaction, their radiographic success and&#xD;
        their antimicrobial effect in comparison with Atraumatic Restorative Treatment (ART) hand&#xD;
        excavation method for caries removal.&#xD;
  &#xD;
        The trial will include 108 children with age ranging between 8 and 10 years old who have at&#xD;
        least one carious first permanent molar will be randomly divided into three groups. A&#xD;
        three-arm randomized clinical trial where test groups, group I, caries removal will be using&#xD;
        Brix 3000, and group II Papacarie duo will be used, while the control group hand excavation&#xD;
        will be the method of caries removal. Dentin samples of three groups will be taken prior to&#xD;
        and following caries removal. The total viable streptococci and lactobacilli count will be&#xD;
        determined and expressed as colony forming units per milliliter (CFU). The time required for&#xD;
        caries removal with each method will be calculated and the subjective pain reaction following&#xD;
        each method will be recorded. After complete caries removal step, it will be followed by&#xD;
        restoration with glass ionomer restoration. Patients will be followed up at 3-, 6- and&#xD;
        12-month intervals to determine the clinical success and at 6- and 12- month intervals for&#xD;
        the radiographic success rate for each caries removal method.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All the lesions in the children's oral cavity indicated for treatment will be treated and&#xD;
        sampled for microbiological analysis prior to and following caries removal. On the day of the&#xD;
        intervention, the children will be asked to refrain from tooth brushing in the morning, as&#xD;
        well as eating and drinking (except water) for at least two hours before the appointment. The&#xD;
        patients will be instructed to rinse with a cup of water, then the outer surface of the&#xD;
        carious lesion will be washed with a flurry of water to avoid contamination of plaque&#xD;
        bacteria. The tooth will then be partially isolated using cotton rolls and saliva ejector.&#xD;
  &#xD;
        Two portions of dentin will be collected with sterile excavators from the middle of the&#xD;
        cavity to perform the microbiological analysis of each tooth before and then after caries&#xD;
        removal procedure. The dentin sample will then be inserted in a sterile test tube containing&#xD;
        1 mL of saline and transported to the microbiology laboratory within 1-2 hours. The bacterial&#xD;
        count obtained for a given amount of dentin will be used to estimate the number of colonies&#xD;
        present in 1 mg dentin (CFU/mg). In the CMCR group: either Papacarie duo or Brix 3000 gel&#xD;
        will be applied on the carious lesion of tooth and left undisturbed for 30-60 seconds,&#xD;
        following manufacturer instructions This produces softening of carious dentin, which will be&#xD;
        removed with a hand excavator. This step will be repeated 2-3 times until dentin demonstrates&#xD;
        slight resistance with no tug-back sensation when tested with an exploratory probe while&#xD;
        pressing an explorer into dentin, then the application of the chemo-mechanical agents will be&#xD;
        stop The visual test for assessment of complete caries excavation will be based on non-turbid&#xD;
        appearance of the CMCR agent used. In the ART group hand excavation will be performed to&#xD;
        remove the carious tissue from the cavity by using a sterile sharp hand excavator. The cavity&#xD;
        will be determined to be caries-free according to visual and tactile clinical criteria.&#xD;
  &#xD;
        No local anesthesia will be administered as it would alter the pain perception of the patient&#xD;
        unless necessary.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 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, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To assess and compare the efficacy of two chemo-mechanical agents Brix 3000 and Papacarie duo in terms of their clinical success in young permanent molars, in comparison with hand excavation approach</measure>
      <time_frame>one year follow up</time_frame>
      <description>The clinical assessment will be at 3-, 6- and 12-month intervals to evaluate restoration success according to the criteria of atraumatic restorative treatment by Phantumvanit et al. (1996) .Restorations which will receive a score of 0, 1 or 7 will be considered successful while those having a score of 2, 3, 4 or 8 will be considered failures. Those which will receive a score of 5, 6 will be excluded from the analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To assess and compare the efficacy of two chemo-mechanical agents Brix 3000 and Papacarie duo in terms of their radiographic success in young permanent molars, in comparison with hand excavation approach</measure>
      <time_frame>one year follow up</time_frame>
      <description>The radiographic evaluation will be performed using the radiographic subtraction method</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>the required time for complete caries removal for each method</measure>
      <time_frame>immediately after the intervention</time_frame>
      <description>The time needed for complete caries removal will be recorded for each caries removal method.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>f patients' subjective pain reactions following each method</measure>
      <time_frame>immediately after the intervention</time_frame>
      <description>Subjective pain will be assessed after caries removal by means of WongBaker faces scale. It consists of faces with different facial expression for happiness and pain and is scored from 0-5 as 0 is very happy and feels no pain and 5 is very painful</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>antimicrobial effect of two chemo-mechanical caries removal agents</measure>
      <time_frame>immediately after the intervention</time_frame>
      <description>Samples from the carious lesion will be collected prior to and following complete caries removal for detection of the change in bacterial count (Streptococci and Lactobacilli counts).</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">108</enrollment>
    <condition>Dental Caries</condition>
    <arm_group>
      <arm_group_label>BRIX 3000</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>brix 3000 used</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Papacarie</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>papacarie duo used</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Hand excavation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>hand excavation used</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>BRIX3000</intervention_name>
      <description>chemo-mechanical caries removal agent</description>
      <arm_group_label>BRIX 3000</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>papacarie</intervention_name>
      <description>chemo-mechanical caries removal agent</description>
      <arm_group_label>Papacarie</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>hand excavation</intervention_name>
      <description>mechanical caries removal</description>
      <arm_group_label>Hand excavation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy children aged 8-10 years old.&#xD;
  &#xD;
            2. The presence of at least one deep carious class 1 lesion in the first permanent molar&#xD;
               with a score of 5 or 6 according to the International Detection and Assessment System&#xD;
               (ICDAS), detected by visual-tactile inspection to assess lesion severity&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Children reporting spontaneous or elicited pain from caries or showing any signs of&#xD;
               pulpal infection, swelling or abscess.&#xD;
  &#xD;
            2. Pulpal exposure or bleeding during the excavation procedure&#xD;
  &#xD;
            3. Children presenting with special health care needs or undergoing medical treatment for&#xD;
               chronic or acute diseases affecting salivary flow.&#xD;
  &#xD;
            4. Allergy or sensitivity to any of the materials included in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dalia A Talaat, PHD</last_name>
      <role>Study Director</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Passant HM Hassanein, MSC</last_name>
      <phone>+201007749463</phone>
      <email>passant.metwally@alexu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Abdelwahab Samaha, PHD</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Faculty of Dentistry</name>
        <address>
          <city>Alexandria</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Passant HM Hassanein, MSC</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 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 Caries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>study protocol will be availabe</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>June 2023- June 2024</ipd_time_frame>
      <ipd_access_criteria>Researchers interested</ipd_access_criteria>
      <ipd_url>http://clinicalTrials.gov</ipd_url>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>February 9, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT05983900/Prot_SAP_ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05983900
  org study id: 9197358
  nct id: NCT05983900
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Minimally invasive dentistry continues to gain importance, especially in the treatment of
        permanent teeth with deep caries lesions and immature roots. Chemo-mechanical caries removal
        (CMCR) is an alternative to the conventional method and consists of the application of a
        proteolytic substance that softens carious dentin tissue and facilitates its removal using
        manual instruments. This method can be employed without the use of local anesthesia or burs,
        thereby preserving sound dental tissue.
  
        The trial aim to assess the clinical performance of Brix 3ooo and Papacarie duo gel as
        chemo-mechanical caries removal agents (CMCR), their performance in terms of time required
        for the caries removal, patient subjective pain reaction, their radiographic success and
        their antimicrobial effect in comparison with Atraumatic Restorative Treatment (ART) hand
        excavation method for caries removal.
  
        The trial will include 108 children with age ranging between 8 and 10 years old who have at
        least one carious first permanent molar will be randomly divided into three groups. A
        three-arm randomized clinical trial where test groups, group I, caries removal will be using
        Brix 3000, and group II Papacarie duo will be used, while the control group hand excavation
        will be the method of caries removal. Dentin samples of three groups will be taken prior to
        and following caries removal. The total viable streptococci and lactobacilli count will be
        determined and expressed as colony forming units per milliliter (CFU). The time required for
        caries removal with each method will be calculated and the subjective pain reaction following
        each method will be recorded. After complete caries removal step, it will be followed by
        restoration with glass ionomer restoration. Patients will be followed up at 3-, 6- and
        12-month intervals to determine the clinical success and at 6- and 12- month intervals for
        the radiographic success rate for each caries removal method.
  All the lesions in the children's oral cavity indicated for treatment will be treated and
        sampled for microbiological analysis prior to and following caries removal. On the day of the
        intervention, the children will be asked to refrain from tooth brushing in the morning, as
        well as eating and drinking (except water) for at least two hours before the appointment. The
        patients will be instructed to rinse with a cup of water, then the outer surface of the
        carious lesion will be washed with a flurry of water to avoid contamination of plaque
        bacteria. The tooth will then be partially isolated using cotton rolls and saliva ejector.
  
        Two portions of dentin will be collected with sterile excavators from the middle of the
        cavity to perform the microbiological analysis of each tooth before and then after caries
        removal procedure. The dentin sample will then be inserted in a sterile test tube containing
        1 mL of saline and transported to the microbiology laboratory within 1-2 hours. The bacterial
        count obtained for a given amount of dentin will be used to estimate the number of colonies
        present in 1 mg dentin (CFU/mg). In the CMCR group: either Papacarie duo or Brix 3000 gel
        will be applied on the carious lesion of tooth and left undisturbed for 30-60 seconds,
        following manufacturer instructions This produces softening of carious dentin, which will be
        removed with a hand excavator. This step will be repeated 2-3 times until dentin demonstrates
        slight resistance with no tug-back sensation when tested with an exploratory probe while
        pressing an explorer into dentin, then the application of the chemo-mechanical agents will be
        stop The visual test for assessment of complete caries excavation will be based on non-turbid
        appearance of the CMCR agent used. In the ART group hand excavation will be performed to
        remove the carious tissue from the cavity by using a sterile sharp hand excavator. The cavity
        will be determined to be caries-free according to visual and tactile clinical criteria.
  
        No local anesthesia will be administered as it would alter the pain perception of the patient
        unless necessary.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: To assess and compare the efficacy of two chemo-mechanical agents Brix 3000 and Papacarie duo in terms of their clinical success in young permanent molars, in comparison with hand excavation approach
  time frame: one year follow up
  description: The clinical assessment will be at 3-, 6- and 12-month intervals to evaluate restoration success according to the criteria of atraumatic restorative treatment by Phantumvanit et al. (1996) .Restorations which will receive a score of 0, 1 or 7 will be considered successful while those having a score of 2, 3, 4 or 8 will be considered failures. Those which will receive a score of 5, 6 will be excluded from the analysis.
  measure: To assess and compare the efficacy of two chemo-mechanical agents Brix 3000 and Papacarie duo in terms of their radiographic success in young permanent molars, in comparison with hand excavation approach
  time frame: one year follow up
  description: The radiographic evaluation will be performed using the radiographic subtraction method
  measure: the required time for complete caries removal for each method
  time frame: immediately after the intervention
  description: The time needed for complete caries removal will be recorded for each caries removal method.
  measure: f patients' subjective pain reactions following each method
  time frame: immediately after the intervention
  description: Subjective pain will be assessed after caries removal by means of WongBaker faces scale. It consists of faces with different facial expression for happiness and pain and is scored from 0-5 as 0 is very happy and feels no pain and 5 is very painful
  measure: antimicrobial effect of two chemo-mechanical caries removal agents
  time frame: immediately after the intervention
  description: Samples from the carious lesion will be collected prior to and following complete caries removal for detection of the change in bacterial count (Streptococci and Lactobacilli counts).
  arm group label: BRIX 3000
  arm group type: Experimental
  description: brix 3000 used
  arm group label: Papacarie
  arm group type: Active Comparator
  description: papacarie duo used
  arm group label: Hand excavation
  arm group type: Active Comparator
  description: hand excavation used
  intervention type: Procedure
  intervention name: BRIX3000
  description: chemo-mechanical caries removal agent
  arm group label: BRIX 3000
  intervention type: Procedure
  intervention name: papacarie
  description: chemo-mechanical caries removal agent
  arm group label: Papacarie
  intervention type: Procedure
  intervention name: hand excavation
  description: mechanical caries removal
  arm group label: Hand excavation
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 10 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dalia A Talaat, PHD
  role: Study Director
  affiliation: Alexandria University
  last name: Passant HM Hassanein, MSC
  phone: +201007749463
  email: passant.metwally@alexu.edu.eg
  last name: Abdelwahab Samaha, PHD
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Dental Caries
  sharing ipd: Yes
  ipd description: study protocol will be availabe
  ipd info type: Study Protocol
  ipd time frame: June 2023- June 2024
  ipd access criteria: Researchers interested
  ipd url: http://clinicalTrials.gov
  provided document: 