<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/NCT03763110</url>
  </required_header>
  <id_info>
    <org_study_id>Regenerative endodontic</org_study_id>
    <nct_id>NCT03763110</nct_id>
  </id_info>
  <brief_title>Photo-Activated Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth</brief_title>
  <official_title>Evaluation of Post-Operative Pain After Regenerative Endodontic Using Photo-Activated Oral Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      This study aims to compare regenerative endodontics for necrotic young permanent anterior&#xD;
      teeth using oral photo-activated disinfection versus triple antibiotic paste in terms of:&#xD;
&#xD;
        1. Clinical success in terms of absence of any complication such as spontaneous pain, sinus&#xD;
           or swelling.&#xD;
&#xD;
        2. Radiographic success in terms of healing of periapical radiolucency or increase root&#xD;
           thickness, length or apical closure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Disinfection of the root canal system is thought to be critical to the success of&#xD;
      Regenerative Endodontic Procedures (REPs) as infection prevents regeneration, repair and stem&#xD;
      cell activity . A suitable material for using as intra-canal medicament seems to be&#xD;
      antibiotic. Triple antibiotic paste (TAP) containing metronidazole, ciprofloxacin and&#xD;
      minocycline has been reported to be a successful regimen in controlling the root canal&#xD;
      pathogen and in managing necrotic young permanent tooth .&#xD;
&#xD;
      Recently, new disinfection methods have been developed to overcome the limitations of&#xD;
      conventional disinfecting protocols that they may neither reduce the number of bacteria to a&#xD;
      satisfactory level nor minimize the toxicity to periapical stem/progenitors . Other concerns&#xD;
      regarding the use of TAP are tooth discoloration after treatment and bacterial resistance.&#xD;
      Photo-activated oral disinfection is a novel disinfection method which present a great&#xD;
      solution for the problem associated with triple antibiotic paste&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 15, 2016</start_date>
  <completion_date type="Anticipated">April 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2018</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>absence of postoperative pain</measure>
    <time_frame>immediate post operative</time_frame>
    <description>binary question by asking patients (yes or no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>absence of postoperative pain</measure>
    <time_frame>at 3 months follow up</time_frame>
    <description>binary question by asking patients (yes or no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>absence of postoperative pain</measure>
    <time_frame>at 6 months follow up</time_frame>
    <description>binary question by asking patients (yes or no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>absence of postoperative pain</measure>
    <time_frame>at 9 months follow up</time_frame>
    <description>binary question by asking patients (yes or no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>absence of postoperative pain</measure>
    <time_frame>at 12 months follow up</time_frame>
    <description>binary question by asking patients (yes or no)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>healing of sinus</measure>
    <time_frame>immediate post operative, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>Clinical success in term of absence of sinus (Yes or No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>healing of swelling</measure>
    <time_frame>immediate post operative, 3 months, 6 months, 9 months, 12 months</time_frame>
    <description>Clinical success in term of absence of swelling (Yes or No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>healing of periapical radiolucency</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>Radiographic success in term of healing of periapical or radiolucency (Yes or No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in root length</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>Radiographic evaluation by calibration of root length in millimetre by Digora</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in dentin root thickness</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>Radiographic evaluation by calibration of root thickness in millimetre by Digora</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in apical diameter</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>Radiographic evaluation by calibration of apical diameter in millimetre by Digora</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pulp Necrosis</condition>
  <arm_group>
    <arm_group_label>Photo Activated Disinfection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Photoactivated disinfection (PAD) is based on the interaction of a photosensitive antibacterial agent and a light source. It uses a nontoxic dye [named photosensitizer PS] and low-intensity visible light. In oxygen presentation, these combine to produce some cytotoxic species. The PS molecules attach to bacteria membrane</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antibiotic paste</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hoshino et al. recommended a ratio of 1:1:1 of metronidazole (500 mg), minocycline (100 mg) and ciprofloxacin (200 mg) for the 3Mix formulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Photo Activated Disinfection</intervention_name>
    <description>Photoactivated disinfection (PAD) is based on the interaction of a photosensitive antibacterial agent and a light source. It uses a nontoxic dye [named photosensitizer PS] and low-intensity visible light. In oxygen presentation, these combine to produce some cytotoxic species. The PS molecules attach to bacteria membrane</description>
    <arm_group_label>Photo Activated Disinfection</arm_group_label>
    <other_name>Photodynamic therapy (PDT)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>antibiotic paste</intervention_name>
    <description>An antibiotic mixture composed of ciproﬂoxacin, metronidazole, and minocycline, known as triple antibiotic paste (TAP) or &quot;3mix&quot;, has been the most widely used medicament, This goes back to the studies by Hoshino et al.1996</description>
    <arm_group_label>Antibiotic paste</arm_group_label>
    <other_name>Triple antibiotic paste</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy children with no physical, mental or systemic conditions.&#xD;
&#xD;
          -  Developmental age of the child is the most important factor so periapical x- ray will&#xD;
             be taken first to assure apex immaturity.&#xD;
&#xD;
          -  No sex predilection.&#xD;
&#xD;
          -  Restorable necrotic young permanent anterior teeth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Root fracture.&#xD;
&#xD;
          -  Internal or external root resorption.&#xD;
&#xD;
          -  Parents or guardians refuse to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>ElShaimaa Abdelhafiz Abdelrahim</investigator_full_name>
    <investigator_title>assistant lecturer in paediatric dentistry department at Fayoum university</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Pulp Necrosis</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Antibiotics, Antitubercular</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03763110
org study id: Regenerative endodontic
nct id: NCT03763110
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to compare regenerative endodontics for necrotic young permanent anterior
      teeth using oral photo-activated disinfection versus triple antibiotic paste in terms of:

        1. Clinical success in terms of absence of any complication such as spontaneous pain, sinus
           or swelling.

        2. Radiographic success in terms of healing of periapical radiolucency or increase root
           thickness, length or apical closure.
Disinfection of the root canal system is thought to be critical to the success of
      Regenerative Endodontic Procedures (REPs) as infection prevents regeneration, repair and stem
      cell activity . A suitable material for using as intra-canal medicament seems to be
      antibiotic. Triple antibiotic paste (TAP) containing metronidazole, ciprofloxacin and
      minocycline has been reported to be a successful regimen in controlling the root canal
      pathogen and in managing necrotic young permanent tooth .

      Recently, new disinfection methods have been developed to overcome the limitations of
      conventional disinfecting protocols that they may neither reduce the number of bacteria to a
      satisfactory level nor minimize the toxicity to periapical stem/progenitors . Other concerns
      regarding the use of TAP are tooth discoloration after treatment and bacterial resistance.
      Photo-activated oral disinfection is a novel disinfection method which present a great
      solution for the problem associated with triple antibiotic paste
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: absence of postoperative pain
time frame: immediate post operative
description: binary question by asking patients (yes or no)
measure: absence of postoperative pain
time frame: at 3 months follow up
description: binary question by asking patients (yes or no)
measure: absence of postoperative pain
time frame: at 6 months follow up
description: binary question by asking patients (yes or no)
measure: absence of postoperative pain
time frame: at 9 months follow up
description: binary question by asking patients (yes or no)
measure: absence of postoperative pain
time frame: at 12 months follow up
description: binary question by asking patients (yes or no)
measure: healing of sinus
time frame: immediate post operative, 3 months, 6 months, 9 months, 12 months
description: Clinical success in term of absence of sinus (Yes or No)
measure: healing of swelling
time frame: immediate post operative, 3 months, 6 months, 9 months, 12 months
description: Clinical success in term of absence of swelling (Yes or No)
measure: healing of periapical radiolucency
time frame: baseline, 6 months, 12 months
description: Radiographic success in term of healing of periapical or radiolucency (Yes or No)
measure: change in root length
time frame: baseline, 6 months, 12 months
description: Radiographic evaluation by calibration of root length in millimetre by Digora
measure: change in dentin root thickness
time frame: baseline, 6 months, 12 months
description: Radiographic evaluation by calibration of root thickness in millimetre by Digora
measure: change in apical diameter
time frame: baseline, 6 months, 12 months
description: Radiographic evaluation by calibration of apical diameter in millimetre by Digora
arm group label: Photo Activated Disinfection
arm group type: Experimental
description: Photoactivated disinfection (PAD) is based on the interaction of a photosensitive antibacterial agent and a light source. It uses a nontoxic dye [named photosensitizer PS] and low-intensity visible light. In oxygen presentation, these combine to produce some cytotoxic species. The PS molecules attach to bacteria membrane
arm group label: Antibiotic paste
arm group type: Active Comparator
description: Hoshino et al. recommended a ratio of 1:1:1 of metronidazole (500 mg), minocycline (100 mg) and ciprofloxacin (200 mg) for the 3Mix formulation
intervention type: Device
intervention name: Photo Activated Disinfection
description: Photoactivated disinfection (PAD) is based on the interaction of a photosensitive antibacterial agent and a light source. It uses a nontoxic dye [named photosensitizer PS] and low-intensity visible light. In oxygen presentation, these combine to produce some cytotoxic species. The PS molecules attach to bacteria membrane
arm group label: Photo Activated Disinfection
other name: Photodynamic therapy (PDT)
intervention type: Drug
intervention name: antibiotic paste
description: An antibiotic mixture composed of ciproﬂoxacin, metronidazole, and minocycline, known as triple antibiotic paste (TAP) or "3mix", has been the most widely used medicament, This goes back to the studies by Hoshino et al.1996
arm group label: Antibiotic paste
other name: Triple antibiotic paste
criteria: 
gender: All
minimum age: 8 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: ElShaimaa Abdelhafiz Abdelrahim
investigator title: assistant lecturer in paediatric dentistry department at Fayoum university
mesh term: Dental Pulp Necrosis
mesh term: Necrosis
mesh term: Anti-Bacterial Agents
mesh term: Antibiotics, Antitubercular