<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/NCT02241577</url>
  </required_header>
  <id_info>
    <org_study_id>UFRGSimplant2014</org_study_id>
    <secondary_id>CNPq14_2013</secondary_id>
    <nct_id>NCT02241577</nct_id>
  </id_info>
  <brief_title>Surgical and Non-surgical Treatment of Peri-implantitis</brief_title>
  <acronym>Perio-implants</acronym>
  <official_title>Surgical and Non-surgical Treatment of Peri-implantitis: Multi-center Randomised Controlled Trial of 12-months Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Rio Grande do Sul</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare surgical and non surgical treatments of peri-implantitis.&#xD;
      Peri-implantitis is an inflammation around dental implants that can lead to the loss of the&#xD;
      implant over time if no treatment is established. The signs of peri-implantitis included&#xD;
      bleeding of the gingiva, swelling and redness. Most of times there is no pain. Patients&#xD;
      presenting with these characteristics will be included at random to one of the treatment&#xD;
      groups. Those allocated to the non-surgical group will received implant cleansing after local&#xD;
      anesthesia using adequate instruments. In the surgical group, patients will be submitted to a&#xD;
      surgical procedure around the implant for visualization and cleansing also after local&#xD;
      anesthesia. All patients will be followed over a 12-month period. The hypothesis is that&#xD;
      surgical treatment is better than non-surgical treatment regarding clinical, radiographic,&#xD;
      microbiological, and immunological.characteristics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">August 2019</completion_date>
  <primary_completion_date type="Actual">August 2019</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pocket depth reduction</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level changes</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alveolar bone level changes</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subgingival microbiota changes</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival crevicular fluid immune-inflammatory biomarkers</measure>
    <time_frame>12 motnhs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum biomarkers of inflammation</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Peri-implantitis</condition>
  <arm_group>
    <arm_group_label>Surgical treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgical access for scaling and disinfection of dental implant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-surgical treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-surgical subgingival scaling and disinfection of dental implant</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical treatment</intervention_name>
    <description>Flap surgery around dental implant for scaling and disinfection of the titanium surface under local anesthesia</description>
    <arm_group_label>Surgical treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-surgical treatment</intervention_name>
    <description>Non-surgical subgingival scaling and disinfection of the titanium surface of dental implant under local anesthesia</description>
    <arm_group_label>Non-surgical treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals with at least one dental implant with peri-implantitits&#xD;
&#xD;
          -  Individuals with good general health conditions;&#xD;
&#xD;
          -  Individuals presenting at least 10 natural teeth;&#xD;
&#xD;
          -  Individuals with no signs of active periodontitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who received periodontal treatment in the last three months&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Systemic condition that interferes with treatment such as diabetes&#xD;
&#xD;
          -  Individuals who are taking or have taken antibiotics or anti-inflammatory medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cassiano K Rosing, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Federal University of Rio Grande do Sul</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joao Augusto P Oliveira, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Rio Grande do Sul</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tassiane P Wagner, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Rio Grande do Sul</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fernando S Rios, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Rio Grande do Sul</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ricardo SA Costa, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Rio Grande do Sul</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alex Haas</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90630080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://www.ufrgs.br/odonto</url>
    <description>Site of the School of Dentistry</description>
  </link>
  <link>
    <url>http://www.ufrgs.br/ppgodo/index.php</url>
    <description>Site of the Post-graduate Program in Dentistry</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>September 26, 2019</last_update_submitted>
  <last_update_submitted_qc>September 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Rio Grande do Sul</investigator_affiliation>
    <investigator_full_name>Alex Nogueira Haas</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>peri-implantitis</keyword>
  <keyword>dental implants</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>non-surgical periodontal treatment</keyword>
  <keyword>will be defined by the presence of alveolar bone loss of at least 3mm, pocket depth of at least 5mm and bleeding on probing.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peri-Implantitis</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/NCT02241577
org study id: UFRGSimplant2014
secondary id: CNPq14_2013
nct id: NCT02241577
lead sponsor: 
has dmc: No
This study will compare surgical and non surgical treatments of peri-implantitis.
      Peri-implantitis is an inflammation around dental implants that can lead to the loss of the
      implant over time if no treatment is established. The signs of peri-implantitis included
      bleeding of the gingiva, swelling and redness. Most of times there is no pain. Patients
      presenting with these characteristics will be included at random to one of the treatment
      groups. Those allocated to the non-surgical group will received implant cleansing after local
      anesthesia using adequate instruments. In the surgical group, patients will be submitted to a
      surgical procedure around the implant for visualization and cleansing also after local
      anesthesia. All patients will be followed over a 12-month period. The hypothesis is that
      surgical treatment is better than non-surgical treatment regarding clinical, radiographic,
      microbiological, and immunological.characteristics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pocket depth reduction
time frame: 12 months
measure: Clinical attachment level changes
time frame: 12 months
measure: Alveolar bone level changes
time frame: 12 months
measure: Subgingival microbiota changes
time frame: 12 months
measure: Gingival crevicular fluid immune-inflammatory biomarkers
time frame: 12 motnhs
measure: Serum biomarkers of inflammation
time frame: 12 months
measure: Bleeding on probing
time frame: 12 months
arm group label: Surgical treatment
arm group type: Experimental
description: Surgical access for scaling and disinfection of dental implant
arm group label: Non-surgical treatment
arm group type: Experimental
description: Non-surgical subgingival scaling and disinfection of dental implant
intervention type: Procedure
intervention name: Surgical treatment
description: Flap surgery around dental implant for scaling and disinfection of the titanium surface under local anesthesia
arm group label: Surgical treatment
intervention type: Procedure
intervention name: Non-surgical treatment
description: Non-surgical subgingival scaling and disinfection of the titanium surface of dental implant under local anesthesia
arm group label: Non-surgical treatment
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Cassiano K Rosing, PhD
role: Study Chair
affiliation: Federal University of Rio Grande do Sul
last name: Joao Augusto P Oliveira, MS
role: Principal Investigator
affiliation: Federal University of Rio Grande do Sul
last name: Tassiane P Wagner, DDS
role: Principal Investigator
affiliation: Federal University of Rio Grande do Sul
last name: Fernando S Rios, MS
role: Principal Investigator
affiliation: Federal University of Rio Grande do Sul
last name: Ricardo SA Costa, MS
role: Principal Investigator
affiliation: Federal University of Rio Grande do Sul
facility: 
country: Brazil
url: http://www.ufrgs.br/odonto
description: Site of the School of Dentistry
url: http://www.ufrgs.br/ppgodo/index.php
description: Site of the Post-graduate Program in Dentistry
responsible party type: Principal Investigator
investigator affiliation: Federal University of Rio Grande do Sul
investigator full name: Alex Nogueira Haas
investigator title: Associate Professor
mesh term: Peri-Implantitis