<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/NCT02196740</url>
  </required_header>
  <id_info>
    <org_study_id>Tri-antibiotic-2014</org_study_id>
    <nct_id>NCT02196740</nct_id>
  </id_info>
  <brief_title>Research of the Application of Triple Antibiotic Paste in Primary Teeth With Pericpical Periodontitis</brief_title>
  <official_title>Randomized Controlled Research of the Application of Triple Antibiotic Paste in Primary Teeth With</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lin Jiacheng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The triple antibiotic paste is widely used in young permanent teeth and permanent teeth root&#xD;
      canal therapy with excellent antiantimicrobial effect.We hypothesize that its application in&#xD;
      the treatment of periapical periodontitis of deciduous teeth is superior to other drugs&#xD;
      currently in use as creosote.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We design to collect a group of patients presenting primary teeth with periapical&#xD;
      periodontitis in certain criterion. We will divide the patients into two groups randomly.One&#xD;
      group will get treated with triple antibiotic paste while the other with creosote.We want to&#xD;
      evaluate the short-term and long-term effects of the two groups to get a conclusion of the&#xD;
      clinical value of triple antibiotic paste.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2013</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of lesion healing confirmed by cone beam computed tomography and X-rays</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Periapical Diseases</condition>
  <arm_group>
    <arm_group_label>creosote</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Creosote ，once，three weeks Triple Antibiotic Paste ，none</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triple Antibiotic Paste</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Triple Antibiotic Paste,once,three weeks creosote,none</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste</intervention_name>
    <description>Pulp removal,Root canal irrigation and disinfection,</description>
    <arm_group_label>Triple Antibiotic Paste</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>creosote</intervention_name>
    <description>Pulp removal,Root canal irrigation and disinfection</description>
    <arm_group_label>creosote</arm_group_label>
    <other_name>oily liquid obtained by distillation of wood tar</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of periapical periodontitis&#xD;
&#xD;
          -  must be primary teeth&#xD;
&#xD;
          -  must be 3~8 years old&#xD;
&#xD;
          -  the permanent tooth germ is complete and didnot be involved&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  blood disease&#xD;
&#xD;
          -  residual root that is advised to extract&#xD;
&#xD;
          -  serious periodontitis&#xD;
&#xD;
          -  allergy to the triple antibiotic paste&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiacheng Lin</last_name>
    <role>Study Chair</role>
    <affiliation>Guanghua hospital of stomotology,Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jicheng Lin</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510055</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Bezgin T, Yilmaz AD, Celik BN, Sonmez H. Concentrated platelet-rich plasma used in root canal revascularization: 2 case reports. Int Endod J. 2014 Jan;47(1):41-9. doi: 10.1111/iej.12144. Epub 2013 Jun 17.</citation>
    <PMID>23772873</PMID>
  </reference>
  <reference>
    <citation>Nagata JY, Gomes BP, Rocha Lima TF, Murakami LS, de Faria DE, Campos GR, de Souza-Filho FJ, Soares Ade J. Traumatized immature teeth treated with 2 protocols of pulp revascularization. J Endod. 2014 May;40(5):606-12. doi: 10.1016/j.joen.2014.01.032. Epub 2014 Mar 6.</citation>
    <PMID>24767551</PMID>
  </reference>
  <reference>
    <citation>Nagata JY, Soares AJ, Souza-Filho FJ, Zaia AA, Ferraz CC, Almeida JF, Gomes BP. Microbial evaluation of traumatized teeth treated with triple antibiotic paste or calcium hydroxide with 2% chlorhexidine gel in pulp revascularization. J Endod. 2014 Jun;40(6):778-83. doi: 10.1016/j.joen.2014.01.038. Epub 2014 Apr 29.</citation>
    <PMID>24862703</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Lin Jiacheng</investigator_full_name>
    <investigator_title>Research Associate</investigator_title>
  </responsible_party>
  <keyword>periapical periodontitis,primary teeth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periapical Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
    <mesh_term>Ciprofloxacin</mesh_term>
    <mesh_term>Clindamycin</mesh_term>
    <mesh_term>Clindamycin palmitate</mesh_term>
    <mesh_term>Clindamycin phosphate</mesh_term>
    <mesh_term>Gatifloxacin</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/NCT02196740
org study id: Tri-antibiotic-2014
nct id: NCT02196740
lead sponsor: 
has dmc: Yes
The triple antibiotic paste is widely used in young permanent teeth and permanent teeth root
      canal therapy with excellent antiantimicrobial effect.We hypothesize that its application in
      the treatment of periapical periodontitis of deciduous teeth is superior to other drugs
      currently in use as creosote.
We design to collect a group of patients presenting primary teeth with periapical
      periodontitis in certain criterion. We will divide the patients into two groups randomly.One
      group will get treated with triple antibiotic paste while the other with creosote.We want to
      evaluate the short-term and long-term effects of the two groups to get a conclusion of the
      clinical value of triple antibiotic paste.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Evidence of lesion healing confirmed by cone beam computed tomography and X-rays
time frame: 1 year
arm group label: creosote
arm group type: Active Comparator
description: Creosote ，once，three weeks Triple Antibiotic Paste ，none
arm group label: Triple Antibiotic Paste
arm group type: Experimental
description: Triple Antibiotic Paste,once,three weeks creosote,none
intervention type: Drug
intervention name: Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste
description: Pulp removal,Root canal irrigation and disinfection,
arm group label: Triple Antibiotic Paste
intervention type: Drug
intervention name: creosote
description: Pulp removal,Root canal irrigation and disinfection
arm group label: creosote
other name: oily liquid obtained by distillation of wood tar
criteria: 
gender: All
minimum age: 3 Years
maximum age: 8 Years
healthy volunteers: No
last name: Jiacheng Lin
role: Study Chair
affiliation: Guanghua hospital of stomotology,Sun Yat-sen University
facility: 
country: China
citation: Bezgin T, Yilmaz AD, Celik BN, Sonmez H. Concentrated platelet-rich plasma used in root canal revascularization: 2 case reports. Int Endod J. 2014 Jan;47(1):41-9. doi: 10.1111/iej.12144. Epub 2013 Jun 17.
PMID: 23772873
citation: Nagata JY, Gomes BP, Rocha Lima TF, Murakami LS, de Faria DE, Campos GR, de Souza-Filho FJ, Soares Ade J. Traumatized immature teeth treated with 2 protocols of pulp revascularization. J Endod. 2014 May;40(5):606-12. doi: 10.1016/j.joen.2014.01.032. Epub 2014 Mar 6.
PMID: 24767551
citation: Nagata JY, Soares AJ, Souza-Filho FJ, Zaia AA, Ferraz CC, Almeida JF, Gomes BP. Microbial evaluation of traumatized teeth treated with triple antibiotic paste or calcium hydroxide with 2% chlorhexidine gel in pulp revascularization. J Endod. 2014 Jun;40(6):778-83. doi: 10.1016/j.joen.2014.01.038. Epub 2014 Apr 29.
PMID: 24862703
responsible party type: Sponsor-Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Lin Jiacheng
investigator title: Research Associate
mesh term: Periapical Diseases
mesh term: Metronidazole
mesh term: Ciprofloxacin
mesh term: Clindamycin
mesh term: Clindamycin palmitate
mesh term: Clindamycin phosphate
mesh term: Gatifloxacin