<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/NCT01699568</url>
  </required_header>
  <id_info>
    <org_study_id>Erico1</org_study_id>
    <nct_id>NCT01699568</nct_id>
  </id_info>
  <brief_title>Stability of Implants With Different Surface Treatment: Randomized Clinical Trial</brief_title>
  <official_title>Stability of Implants With Different Surface Treatment: Randomized 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>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: To compare the stability of implant surface treated by dual acid etching&#xD;
      (Porous)and implants with anodized surface (Vulcano) over a period of 16 weeks after&#xD;
      installation.&#xD;
&#xD;
      Methods: it will be a clinical study with individuals with missing teeth requiring&#xD;
      rehabilitation with dental implants in the maxilla and that fulfill the study inclusion&#xD;
      criteria. The research sites will be randomized into two groups: the control group patient's&#xD;
      sites receive implant surface treated by dual acid (AR Torque Porous, Connection Implant&#xD;
      Systems, Aruja, Brazil) and in the test group implants with anodized surface (AR Torque&#xD;
      Vulcano-Actives, Connection Implant Systems, Aruja, Brazil). The evaluation of the stability&#xD;
      of the implants will be made over 16 weeks, through resonance frequency analysis with Osstell&#xD;
      (Integration Diagnostics AB, Gothenburg, Sweden). Data will be analyzed using descriptive&#xD;
      statistics and comparative.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <primary_completion_date type="Anticipated">July 2013</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>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>implant loss</measure>
    <time_frame>4 months</time_frame>
    <description>During the osseointegration, if the implant lose his stability and if it show spin and if the patient have pain, the implant will be removed and the implant will be considered lost</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ISQ analysis</measure>
    <time_frame>6 months</time_frame>
    <description>Since the implant installation, for the next 8 weeks, and after for the next 4 months, the implant stability will be measure with the Osstell, that will return a number between 0 and 100. This represents the Implant Stability Quotient (ISQ). The difference between the ISQ results will be the secondary outcome measure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Edentulous Jaws Partially</condition>
  <arm_group>
    <arm_group_label>Vulcano Actives</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implants 4mm x 10mm Vulcano Actives (anodized surface)(AR Torque Vulcano actives), Conexão Sistemas de Prótese, Arujá, Brasil)will be placed on edentulous area in maxilla</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Porous</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implants 4mm x 10mm Porous (dual acid-etched surface treatment)(AR Torque Porous, Conexão Sistemas de Prótese, Arujá, Brasil)will be placed on edentulous area in maxilla</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RFA</intervention_name>
    <description>Each week since the surgery the implant stability will be measure with the Osstell mentor to verify the resonance frequence analysis, using the smartpeg number 21</description>
    <arm_group_label>Porous</arm_group_label>
    <arm_group_label>Vulcano Actives</arm_group_label>
    <other_name>Osstell mentor</other_name>
    <other_name>resonance frequence analysis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who have missing teeth in the maxilla,&#xD;
&#xD;
          -  over 30 years old and under 60 years old,&#xD;
&#xD;
          -  the implant sites with at least 3 months of healing after extraction,&#xD;
&#xD;
          -  the implant sites with width and length to installation of an implant of 4 mm x 10 mm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who experience any of the following conditions:&#xD;
&#xD;
          -  general contraindications for surgical procedures,&#xD;
&#xD;
          -  uncontrolled diabetes,&#xD;
&#xD;
          -  severe bruxism or clenching,&#xD;
&#xD;
          -  pregnant and lactating women,&#xD;
&#xD;
          -  active periodontal disease,&#xD;
&#xD;
          -  smoker and user of alcohol or drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Érico Fraga Moreira, Master of Science</last_name>
    <role>Principal Investigator</role>
    <affiliation>Student of doctoral program</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculdade de Odontologia da USP</name>
      <address>
        <city>São Paulo</city>
        <zip>05508-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>February 14, 2013</last_update_submitted>
  <last_update_submitted_qc>February 14, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 15, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Érico Castaldin Fraga Moreira</investigator_full_name>
    <investigator_title>Master of Science</investigator_title>
  </responsible_party>
  <keyword>dental implant stability</keyword>
  <keyword>dental implant surface treatment</keyword>
  <keyword>resonance frequence analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Jaw, Edentulous</mesh_term>
  </condition_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/NCT01699568
org study id: Erico1
nct id: NCT01699568
lead sponsor: 
has dmc: No
Objectives: To compare the stability of implant surface treated by dual acid etching
      (Porous)and implants with anodized surface (Vulcano) over a period of 16 weeks after
      installation.

      Methods: it will be a clinical study with individuals with missing teeth requiring
      rehabilitation with dental implants in the maxilla and that fulfill the study inclusion
      criteria. The research sites will be randomized into two groups: the control group patient's
      sites receive implant surface treated by dual acid (AR Torque Porous, Connection Implant
      Systems, Aruja, Brazil) and in the test group implants with anodized surface (AR Torque
      Vulcano-Actives, Connection Implant Systems, Aruja, Brazil). The evaluation of the stability
      of the implants will be made over 16 weeks, through resonance frequency analysis with Osstell
      (Integration Diagnostics AB, Gothenburg, Sweden). Data will be analyzed using descriptive
      statistics and comparative.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: implant loss
time frame: 4 months
description: During the osseointegration, if the implant lose his stability and if it show spin and if the patient have pain, the implant will be removed and the implant will be considered lost
measure: ISQ analysis
time frame: 6 months
description: Since the implant installation, for the next 8 weeks, and after for the next 4 months, the implant stability will be measure with the Osstell, that will return a number between 0 and 100. This represents the Implant Stability Quotient (ISQ). The difference between the ISQ results will be the secondary outcome measure
arm group label: Vulcano Actives
arm group type: Experimental
description: Implants 4mm x 10mm Vulcano Actives (anodized surface)(AR Torque Vulcano actives), Conexão Sistemas de Prótese, Arujá, Brasil)will be placed on edentulous area in maxilla
arm group label: Porous
arm group type: Active Comparator
description: Implants 4mm x 10mm Porous (dual acid-etched surface treatment)(AR Torque Porous, Conexão Sistemas de Prótese, Arujá, Brasil)will be placed on edentulous area in maxilla
intervention type: Device
intervention name: RFA
description: Each week since the surgery the implant stability will be measure with the Osstell mentor to verify the resonance frequence analysis, using the smartpeg number 21
arm group label: Porous
arm group label: Vulcano Actives
other name: Osstell mentor
other name: resonance frequence analysis
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
last name: Érico Fraga Moreira, Master of Science
role: Principal Investigator
affiliation: Student of doctoral program
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Érico Castaldin Fraga Moreira
investigator title: Master of Science
mesh term: Jaw, Edentulous