<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/NCT02216942</url>
  </required_header>
  <id_info>
    <org_study_id>FOUSP2408</org_study_id>
    <nct_id>NCT02216942</nct_id>
  </id_info>
  <brief_title>Endodontic Treatment of Necrotic Primary Teeth With Guedes Pinto Paste: A Randomized Clinical Trial</brief_title>
  <official_title>Endodontic Treatment of Primary Teeth With Guedes Pinto Paste: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fausto Medeiros Mendes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The maintenance of primary teeth until their exfoliation has been one of the main purposes of&#xD;
      Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the&#xD;
      permanent dentition. Often, injuries or extensive dental caries reach the pulp of deciduous&#xD;
      teeth making maintenance on these dependent endodontic treatment arc. Thus, this study was to&#xD;
      conduct a randomized clinical trial with longitudinal follow-up of two years, double blind,&#xD;
      to compare the degree of success of endodontic treatment in primary among the most used&#xD;
      folder, Guedes Pinto paste, and one Calcium hydroxide and iodoform paste to control, Vitapex.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After approval by the ethics committee of the patients Faculty of Dentistry, University of&#xD;
      São Paulo that having root canal filling of primary teeth will be invited to participate in&#xD;
      the study. A clinical examination and prior radiographic diagnosis and also a quality of life&#xD;
      questionnaire regarding oral health (- ECOHIS Early Childhood Oral Health Impact Scale) will&#xD;
      be-held. The patient will be randomized to one of two groups and will be held endodontics by&#xD;
      a blind handler. The patient will be accompanied with periods of one week, six months, 12&#xD;
      months and 24 months by a blinded evaluator. At the last visit of the review ECOHIS&#xD;
      questionnaire will be reapplied to those responsible. The outcome will be the success or&#xD;
      failure of endodontic treatments evaluated through permanent tooth in the arch on clinical&#xD;
      and radiographic conditions of normality. The longevity of the treatments will be evaluated&#xD;
      by estimating survival rates by Kaplan-Meier. The differences between the survival rates&#xD;
      according to the type of proposed endodontic treatment will be analyzed using the log-rank&#xD;
      test with a minimum significance level of 5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">July 2015</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>
  </study_design_info>
  <primary_outcome>
    <measure>Success or failure of two endodontic treatments</measure>
    <time_frame>two years</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: absence / reduction of periapical bone rarefaction in anterior and absence / bone rarefaction in the furcation area of later, 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 will be between the initial and follow-up radiographs. Radiographs will be scanned and the end of the bone rarefactions starting area and will be measured on a software image analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of the obturation obtained with the two root canal filling pastes</measure>
    <time_frame>two years</time_frame>
    <description>The quality of the filling will be assessed by a blinded examiner according to two criteria. Through an index that ranks the shutter in satisfactory, questionable or unsatisfactory and through evaluation of digital radiographic images with the aid of a computational tool (Autodesk AutoCAD), where the visible areas of the root canal will be measured in previous radiographic examination and their measurements of the area of the root canal filling pastes filled with channels. The influence of the quality of the filling in the successful treatment will also be assessed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Endodontic Treatment of Primary Teeth</condition>
  <arm_group>
    <arm_group_label>Vitapex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endodontic treatment using Vitapex</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Guedes Pinto Paste</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endodontic treatment using Guedes Pinto</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Endodontic treatment using Vitapex</intervention_name>
    <description>Endodontic treatment using Vitapex</description>
    <arm_group_label>Vitapex</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Endodontic treatment using Guedes Pinto</intervention_name>
    <description>Endodontic treatment using Guedes Pinto paste</description>
    <arm_group_label>Guedes Pinto Paste</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary teeth with pulp diagnosis and need endodontic treatment&#xD;
&#xD;
          -  Patients whose guardians consent to their participation in the survey&#xD;
&#xD;
          -  fistula or abscess&#xD;
&#xD;
          -  bone rarefaction or visual diagnosis&#xD;
&#xD;
          -  teeth in the remaining tooth structure and location of the injury rehabilitation&#xD;
             permit&#xD;
&#xD;
          -  do not have internal or external resorption involving more than one third of the root&#xD;
             length&#xD;
&#xD;
          -  have no bone loss in lateral root and disruption crypt and the presence of at least&#xD;
             half of root&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  health problems systemic&#xD;
&#xD;
          -  congenital facial deformities&#xD;
&#xD;
          -  facial tumors&#xD;
&#xD;
          -  syndromes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carmela Bresolin, PHD student</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carmela Bresolin</name>
      <address>
        <city>São Paulo</city>
        <zip>05850010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Kopel HM. Root canal therapy for primary teeth. J Mich State Dent Assoc. 1970 Feb;52(2):28-33 passim. No abstract available.</citation>
    <PMID>5263926</PMID>
  </reference>
  <reference>
    <citation>Garcia-Godoy F. Evaluation of an iodoform paste in root canal therapy for infected primary teeth. ASDC J Dent Child. 1987 Jan-Feb;54(1):30-4.</citation>
    <PMID>3468139</PMID>
  </reference>
  <reference>
    <citation>Rifkin A. A simple, effective, safe technique for the root canal treatment of abscessed primary teeth. ASDC J Dent Child. 1980 Nov-Dec;47(6):435-41. No abstract available.</citation>
    <PMID>6934178</PMID>
  </reference>
  <reference>
    <citation>Rifkin A. The root canal treatment of abscessed primary teeth--a three to four year follow-up. ASDC J Dent Child. 1982 Nov-Dec;49(6):428-31. No abstract available.</citation>
    <PMID>6960030</PMID>
  </reference>
  <reference>
    <citation>Fuks AB. Pulp therapy for the primary and young permanent dentitions. Dent Clin North Am. 2000 Jul;44(3):571-96, vii.</citation>
    <PMID>10925773</PMID>
  </reference>
  <reference>
    <citation>Kubota K, Golden BE, Penugonda B. Root canal filling materials for primary teeth: a review of the literature. ASDC J Dent Child. 1992 May-Jun;59(3):225-7.</citation>
    <PMID>1629445</PMID>
  </reference>
  <reference>
    <citation>Mass E, Zilberman UL. Endodontic treatment of infected primary teeth, using Maisto's paste. ASDC J Dent Child. 1989 Mar-Apr;56(2):117-20.</citation>
    <PMID>2656788</PMID>
  </reference>
  <reference>
    <citation>Srinivasan V, Patchett CL, Waterhouse PJ. Is there life after Buckley's Formocresol? Part I -- a narrative review of alternative interventions and materials. Int J Paediatr Dent. 2006 Mar;16(2):117-27. doi: 10.1111/j.1365-263X.2006.00688.x.</citation>
    <PMID>16430526</PMID>
  </reference>
  <reference>
    <citation>Waterhouse PJ, Nunn JH, Whitworth JM, Soames JV. Primary molar pulp therapy--histological evaluation of failure. Int J Paediatr Dent. 2000 Dec;10(4):313-21. doi: 10.1046/j.1365-263x.2000.00211.x.</citation>
    <PMID>11310245</PMID>
  </reference>
  <reference>
    <citation>Wright KJ, Barbosa SV, Araki K, Spangberg LS. In vitro antimicrobial and cytotoxic effects of Kri 1 paste and zinc oxide-eugenol used in primary tooth pulpectomies. Pediatr Dent. 1994 Mar-Apr;16(2):102-6.</citation>
    <PMID>8015949</PMID>
  </reference>
  <reference>
    <citation>Mani SA, Chawla HS, Tewari A, Goyal A. Evaluation of calcium hydroxide and zinc oxide eugenol as root canal filling materials in primary teeth. ASDC J Dent Child. 2000 Mar-Apr;67(2):142-7, 83. No abstract available.</citation>
    <PMID>10826052</PMID>
  </reference>
  <reference>
    <citation>Amorim Lde F, Toledo OA, Estrela CR, Decurcio Dde A, Estrela C. Antimicrobial analysis of different root canal filling pastes used in pediatric dentistry by two experimental methods. Braz Dent J. 2006;17(4):317-22. doi: 10.1590/s0103-64402006000400010.</citation>
    <PMID>17262146</PMID>
  </reference>
  <reference>
    <citation>Mortazavi M, Mesbahi M. Comparison of zinc oxide and eugenol, and Vitapex for root canal treatment of necrotic primary teeth. Int J Paediatr Dent. 2004 Nov;14(6):417-24. doi: 10.1111/j.1365-263X.2004.00544.x.</citation>
    <PMID>15525310</PMID>
  </reference>
  <results_reference>
    <citation>Bonow MLM, Guedes-Pinto AC,Bammann LL. Antimicrobial activity of drugs used in pulp therapy of deciduous teeth. J EndodBraz, 1: 44-48, 1996</citation>
  </results_reference>
  <results_reference>
    <citation>Guedes-Pinto AC, De Paiva JG, Bozzola JR. [Endodontic treatment of deciduous teeth with pulp necrosis]. Rev Assoc Paul Cir Dent. 1981 May-Jun;35(3):240-4. No abstract available. Portuguese.</citation>
    <PMID>6943625</PMID>
  </results_reference>
  <results_reference>
    <citation>14- Kramer PF, Faraco Junior IM, Feldens CA. Current status of pulp therapy in the Brazilian Universities - Pulpotomy and Pulpectomy Technique in deciduous teeth. J Bras Odontop e OdontolBebe, 3: 222-29, 2000.</citation>
  </results_reference>
  <results_reference>
    <citation>16- Michel JA, Guedes-Pinto AC, AraújoVC. Estudo histopatológico da reação de subcutâneo de camundongos submetidos à ação da pasta Guedes-Pinto utilizada na terapia de dentes decíduos com polpa mortificada. RevFacOdontol São Paulo, 23: 65-72, 1980.</citation>
  </results_reference>
  <results_reference>
    <citation>Nurko C, Ranly DM, Garcia-Godoy F, Lakshmyya KN. Resorption of a calcium hydroxide/iodoform paste (Vitapex) in root canal therapy for primary teeth: a case report. Pediatr Dent. 2000 Nov-Dec;22(6):517-20.</citation>
    <PMID>11132515</PMID>
  </results_reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>February 27, 2018</last_update_submitted>
  <last_update_submitted_qc>February 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Fausto Medeiros Mendes</investigator_full_name>
    <investigator_title>Fausto Medeiros Mendes</investigator_title>
  </responsible_party>
  <keyword>Endodontics</keyword>
  <keyword>Deciduous teeth</keyword>
  <keyword>Iodoform pastes</keyword>
  <keyword>Treatment Refusal</keyword>
  <!-- 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/NCT02216942
org study id: FOUSP2408
nct id: NCT02216942
lead sponsor: 
has dmc: No
The maintenance of primary teeth until their exfoliation has been one of the main purposes of
      Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the
      permanent dentition. Often, injuries or extensive dental caries reach the pulp of deciduous
      teeth making maintenance on these dependent endodontic treatment arc. Thus, this study was to
      conduct a randomized clinical trial with longitudinal follow-up of two years, double blind,
      to compare the degree of success of endodontic treatment in primary among the most used
      folder, Guedes Pinto paste, and one Calcium hydroxide and iodoform paste to control, Vitapex.
After approval by the ethics committee of the patients Faculty of Dentistry, University of
      São Paulo that having root canal filling of primary teeth will be invited to participate in
      the study. A clinical examination and prior radiographic diagnosis and also a quality of life
      questionnaire regarding oral health (- ECOHIS Early Childhood Oral Health Impact Scale) will
      be-held. The patient will be randomized to one of two groups and will be held endodontics by
      a blind handler. The patient will be accompanied with periods of one week, six months, 12
      months and 24 months by a blinded evaluator. At the last visit of the review ECOHIS
      questionnaire will be reapplied to those responsible. The outcome will be the success or
      failure of endodontic treatments evaluated through permanent tooth in the arch on clinical
      and radiographic conditions of normality. The longevity of the treatments will be evaluated
      by estimating survival rates by Kaplan-Meier. The differences between the survival rates
      according to the type of proposed endodontic treatment will be analyzed using the log-rank
      test with a minimum significance level of 5%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Success or failure of two endodontic treatments
time frame: two years
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: absence / reduction of periapical bone rarefaction in anterior and absence / bone rarefaction in the furcation area of later, 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 will be between the initial and follow-up radiographs. Radiographs will be scanned and the end of the bone rarefactions starting area and will be measured on a software image analysis.
measure: Quality of the obturation obtained with the two root canal filling pastes
time frame: two years
description: The quality of the filling will be assessed by a blinded examiner according to two criteria. Through an index that ranks the shutter in satisfactory, questionable or unsatisfactory and through evaluation of digital radiographic images with the aid of a computational tool (Autodesk AutoCAD), where the visible areas of the root canal will be measured in previous radiographic examination and their measurements of the area of the root canal filling pastes filled with channels. The influence of the quality of the filling in the successful treatment will also be assessed.
arm group label: Vitapex
arm group type: Active Comparator
description: Endodontic treatment using Vitapex
arm group label: Guedes Pinto Paste
arm group type: Experimental
description: Endodontic treatment using Guedes Pinto
intervention type: Drug
intervention name: Endodontic treatment using Vitapex
description: Endodontic treatment using Vitapex
arm group label: Vitapex
intervention type: Drug
intervention name: Endodontic treatment using Guedes Pinto
description: Endodontic treatment using Guedes Pinto paste
arm group label: Guedes Pinto Paste
criteria: 
gender: All
minimum age: 1 Year
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carmela Bresolin, PHD student
role: Principal Investigator
affiliation: University of São Paulo
facility: 
country: Brazil
citation: Kopel HM. Root canal therapy for primary teeth. J Mich State Dent Assoc. 1970 Feb;52(2):28-33 passim. No abstract available.
PMID: 5263926
citation: Garcia-Godoy F. Evaluation of an iodoform paste in root canal therapy for infected primary teeth. ASDC J Dent Child. 1987 Jan-Feb;54(1):30-4.
PMID: 3468139
citation: Rifkin A. A simple, effective, safe technique for the root canal treatment of abscessed primary teeth. ASDC J Dent Child. 1980 Nov-Dec;47(6):435-41. No abstract available.
PMID: 6934178
citation: Rifkin A. The root canal treatment of abscessed primary teeth--a three to four year follow-up. ASDC J Dent Child. 1982 Nov-Dec;49(6):428-31. No abstract available.
PMID: 6960030
citation: Fuks AB. Pulp therapy for the primary and young permanent dentitions. Dent Clin North Am. 2000 Jul;44(3):571-96, vii.
PMID: 10925773
citation: Kubota K, Golden BE, Penugonda B. Root canal filling materials for primary teeth: a review of the literature. ASDC J Dent Child. 1992 May-Jun;59(3):225-7.
PMID: 1629445
citation: Mass E, Zilberman UL. Endodontic treatment of infected primary teeth, using Maisto's paste. ASDC J Dent Child. 1989 Mar-Apr;56(2):117-20.
PMID: 2656788
citation: Srinivasan V, Patchett CL, Waterhouse PJ. Is there life after Buckley's Formocresol? Part I -- a narrative review of alternative interventions and materials. Int J Paediatr Dent. 2006 Mar;16(2):117-27. doi: 10.1111/j.1365-263X.2006.00688.x.
PMID: 16430526
citation: Waterhouse PJ, Nunn JH, Whitworth JM, Soames JV. Primary molar pulp therapy--histological evaluation of failure. Int J Paediatr Dent. 2000 Dec;10(4):313-21. doi: 10.1046/j.1365-263x.2000.00211.x.
PMID: 11310245
citation: Wright KJ, Barbosa SV, Araki K, Spangberg LS. In vitro antimicrobial and cytotoxic effects of Kri 1 paste and zinc oxide-eugenol used in primary tooth pulpectomies. Pediatr Dent. 1994 Mar-Apr;16(2):102-6.
PMID: 8015949
citation: Mani SA, Chawla HS, Tewari A, Goyal A. Evaluation of calcium hydroxide and zinc oxide eugenol as root canal filling materials in primary teeth. ASDC J Dent Child. 2000 Mar-Apr;67(2):142-7, 83. No abstract available.
PMID: 10826052
citation: Amorim Lde F, Toledo OA, Estrela CR, Decurcio Dde A, Estrela C. Antimicrobial analysis of different root canal filling pastes used in pediatric dentistry by two experimental methods. Braz Dent J. 2006;17(4):317-22. doi: 10.1590/s0103-64402006000400010.
PMID: 17262146
citation: Mortazavi M, Mesbahi M. Comparison of zinc oxide and eugenol, and Vitapex for root canal treatment of necrotic primary teeth. Int J Paediatr Dent. 2004 Nov;14(6):417-24. doi: 10.1111/j.1365-263X.2004.00544.x.
PMID: 15525310
citation: Bonow MLM, Guedes-Pinto AC,Bammann LL. Antimicrobial activity of drugs used in pulp therapy of deciduous teeth. J EndodBraz, 1: 44-48, 1996
citation: Guedes-Pinto AC, De Paiva JG, Bozzola JR. [Endodontic treatment of deciduous teeth with pulp necrosis]. Rev Assoc Paul Cir Dent. 1981 May-Jun;35(3):240-4. No abstract available. Portuguese.
PMID: 6943625
citation: 14- Kramer PF, Faraco Junior IM, Feldens CA. Current status of pulp therapy in the Brazilian Universities - Pulpotomy and Pulpectomy Technique in deciduous teeth. J Bras Odontop e OdontolBebe, 3: 222-29, 2000.
citation: 16- Michel JA, Guedes-Pinto AC, AraújoVC. Estudo histopatológico da reação de subcutâneo de camundongos submetidos à ação da pasta Guedes-Pinto utilizada na terapia de dentes decíduos com polpa mortificada. RevFacOdontol São Paulo, 23: 65-72, 1980.
citation: Nurko C, Ranly DM, Garcia-Godoy F, Lakshmyya KN. Resorption of a calcium hydroxide/iodoform paste (Vitapex) in root canal therapy for primary teeth: a case report. Pediatr Dent. 2000 Nov-Dec;22(6):517-20.
PMID: 11132515
responsible party type: Sponsor-Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Fausto Medeiros Mendes
investigator title: Fausto Medeiros Mendes