<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/NCT03839485</url>
  </required_header>
  <id_info>
    <org_study_id>FouspPGP</org_study_id>
    <nct_id>NCT03839485</nct_id>
  </id_info>
  <brief_title>Endodontic Treatment of Primary Teeth With Guedes-Pinto Paste Without Antibiotic</brief_title>
  <official_title>Endodontic Treatment of Primary Teeth With Guedes-Pinto Paste Without Antibiotic: Randomized Non-inferiority Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</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>
      The pulp therapy in primary teeth is still necessary even with all odontopediatrics evolution&#xD;
      in prevention and minimal intervention, aiming to keep the tooth free of inflammation or&#xD;
      infection and in a functional state until its exfoliation. Several materials are used as&#xD;
      filling paste of primary teeth. In Brazil, the Guedes-Pinto Paste (PGP), an association of&#xD;
      iodofórmio, camphorated paramonochlorophenol, prednisolone and rifamycin, has been widely&#xD;
      used for some decades. However, current Brazilian legislation has made it difficult to&#xD;
      commercialize antibiotics, which has made it difficult to obtain the ointment that is the&#xD;
      association between prednisolone and rifamycin. Therefore, the objective of this clinical&#xD;
      trial will be to test PGP without rifamycin in the pulpectomy of primary teeth, and to&#xD;
      compare it with the treatment performed with conventional PGP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized triple-blind non-inferiority clinical study with two parallel arms, with a&#xD;
      12-month follow-up, will be performed. The experimental group will be PGP formulated without&#xD;
      the antibiotic, while the control group is the conventional PGP, containing rifamycin. The&#xD;
      conventional pulpectomy will be performed using manual files, performing the instrumentation&#xD;
      aided by Endo-PTC and 1% sodium hypochlorite. At the end of the instrumentation, just before&#xD;
      the obturation, the groups will be drawn, with the strategy of randomization in permuted&#xD;
      blocks and stratified by the initial condition of the tooth (with or without periapical&#xD;
      lesion). The main outcome will be the clinical and radiographic success of endodontic&#xD;
      treatment after 12 months.Patients who seek the dental service of the municipality and&#xD;
      require endodontic treatment will be invited to participate in the study. The data will be&#xD;
      statistically analyzed using the statistical package Stata 12.0 (Stata Corporation, College&#xD;
      Station, TX, USA). The longevity of the treatments will be evaluated by estimating survival&#xD;
      rates using the Kaplan-Meier method. The differences between survival rates according to the&#xD;
      type of endodontic treatment proposed will be analyzed through the Log-rank test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2018</start_date>
  <completion_date type="Actual">April 10, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Both materials will be packed in identical and opaque syringes, identified only with letters (A and B). The codes will be revealed only at the end of the study. Neither the professional who will be performing the treatment, nor the patient or the evaluator, who will perform the exams at follow-up times, will know which of the two materials of choice were selected for each tooth, characterizing the study as triple-blind.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Success or failure of treatment</measure>
    <time_frame>1 year</time_frame>
    <description>The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality. Clinical criteria for determining success are: absence of fistula, absence of painful symptoms and pathological absence of adequate mobility and gingival contour. Radiographically, the success criteria are: no occurrence of a periapical rarefaction in the furcation area; reduction or maintenance of an already present bone rarefaction in the furcation area of posterior teeth, maintaining the periradicular space, root resorption compatible with the eruptive phase and absence of pathological bone resorption. To evaluate the reduction of lesions or appearance of new lesions, we will compare the initial and final radiographs.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Pulp Disorder</condition>
  <arm_group>
    <arm_group_label>Pasta Guedes-Pinto</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endodontic treatment using Guedes-Pinto Paste</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pasta Guedes-Pinto without antibiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endodontic using Guedes-Pinto paste without antibiotic</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Endodontic treatment using Guedes-Pinto Paste</intervention_name>
    <description>Dental procedure in which the entire pulp chamber is removed from the crown and roots of a tooth and the root filling material Guedes-Pinto paste is applied</description>
    <arm_group_label>Pasta Guedes-Pinto</arm_group_label>
    <other_name>Pulpectomy with Guedes-Pinto paste</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Endodontic using Guedes-Pinto Paste without antibiotic</intervention_name>
    <description>Dental procedure in which the entire pulp chamber is removed from the crown and roots of a tooth and the root filling material Guedes-Pinto paste without antibiotic is applied</description>
    <arm_group_label>Pasta Guedes-Pinto without antibiotic</arm_group_label>
    <other_name>Pulpectomy with Guedes-Pinto paste without antibiotic</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary molar teeth with necessity of endodontic treatment.&#xD;
&#xD;
          -  Patients whose parents or guardians consent to their participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic health problems, congenital facial deformities, facial tumors or syndromes&#xD;
&#xD;
          -  Teeth presenting one of the following:&#xD;
&#xD;
               -  Resorption of more than 2/3 of the root&#xD;
&#xD;
               -  Destruction of the crypt of the permanent successor&#xD;
&#xD;
               -  Pulp chamber floor drilling.&#xD;
&#xD;
               -  Presence of internal resorption&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>School of Dentistry, University of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05508-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>April 17, 2021</last_update_submitted>
  <last_update_submitted_qc>April 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Fausto Medeiros Mendes</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>pulpectomy</keyword>
  <keyword>primary teeth</keyword>
  <keyword>root canal filling materials</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Pulp Diseases</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03839485
org study id: FouspPGP
nct id: NCT03839485
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The pulp therapy in primary teeth is still necessary even with all odontopediatrics evolution
      in prevention and minimal intervention, aiming to keep the tooth free of inflammation or
      infection and in a functional state until its exfoliation. Several materials are used as
      filling paste of primary teeth. In Brazil, the Guedes-Pinto Paste (PGP), an association of
      iodofórmio, camphorated paramonochlorophenol, prednisolone and rifamycin, has been widely
      used for some decades. However, current Brazilian legislation has made it difficult to
      commercialize antibiotics, which has made it difficult to obtain the ointment that is the
      association between prednisolone and rifamycin. Therefore, the objective of this clinical
      trial will be to test PGP without rifamycin in the pulpectomy of primary teeth, and to
      compare it with the treatment performed with conventional PGP.
A randomized triple-blind non-inferiority clinical study with two parallel arms, with a
      12-month follow-up, will be performed. The experimental group will be PGP formulated without
      the antibiotic, while the control group is the conventional PGP, containing rifamycin. The
      conventional pulpectomy will be performed using manual files, performing the instrumentation
      aided by Endo-PTC and 1% sodium hypochlorite. At the end of the instrumentation, just before
      the obturation, the groups will be drawn, with the strategy of randomization in permuted
      blocks and stratified by the initial condition of the tooth (with or without periapical
      lesion). The main outcome will be the clinical and radiographic success of endodontic
      treatment after 12 months.Patients who seek the dental service of the municipality and
      require endodontic treatment will be invited to participate in the study. The data will be
      statistically analyzed using the statistical package Stata 12.0 (Stata Corporation, College
      Station, TX, USA). The longevity of the treatments will be evaluated by estimating survival
      rates using the Kaplan-Meier method. The differences between survival rates according to the
      type of endodontic treatment proposed will be analyzed through the Log-rank test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Both materials will be packed in identical and opaque syringes, identified only with letters (A and B). The codes will be revealed only at the end of the study. Neither the professional who will be performing the treatment, nor the patient or the evaluator, who will perform the exams at follow-up times, will know which of the two materials of choice were selected for each tooth, characterizing the study as triple-blind.
measure: Success or failure of treatment
time frame: 1 year
description: The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality. Clinical criteria for determining success are: absence of fistula, absence of painful symptoms and pathological absence of adequate mobility and gingival contour. Radiographically, the success criteria are: no occurrence of a periapical rarefaction in the furcation area; reduction or maintenance of an already present bone rarefaction in the furcation area of posterior teeth, maintaining the periradicular space, root resorption compatible with the eruptive phase and absence of pathological bone resorption. To evaluate the reduction of lesions or appearance of new lesions, we will compare the initial and final radiographs.
arm group label: Pasta Guedes-Pinto
arm group type: Active Comparator
description: Endodontic treatment using Guedes-Pinto Paste
arm group label: Pasta Guedes-Pinto without antibiotic
arm group type: Experimental
description: Endodontic using Guedes-Pinto paste without antibiotic
intervention type: Drug
intervention name: Endodontic treatment using Guedes-Pinto Paste
description: Dental procedure in which the entire pulp chamber is removed from the crown and roots of a tooth and the root filling material Guedes-Pinto paste is applied
arm group label: Pasta Guedes-Pinto
other name: Pulpectomy with Guedes-Pinto paste
intervention type: Drug
intervention name: Endodontic using Guedes-Pinto Paste without antibiotic
description: Dental procedure in which the entire pulp chamber is removed from the crown and roots of a tooth and the root filling material Guedes-Pinto paste without antibiotic is applied
arm group label: Pasta Guedes-Pinto without antibiotic
other name: Pulpectomy with Guedes-Pinto paste without antibiotic
criteria: 
gender: All
minimum age: 4 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Fausto Medeiros Mendes
investigator title: Principal investigator
mesh term: Dental Pulp Diseases
mesh term: Anti-Bacterial Agents
mesh term: Antibiotics, Antitubercular
sharing ipd: No