<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/NCT03031392</url>
  </required_header>
  <id_info>
    <org_study_id>18002909/3</org_study_id>
    <nct_id>NCT03031392</nct_id>
  </id_info>
  <brief_title>Sensitivity and Specificity of Peri-Implantitis-Related Parameters</brief_title>
  <official_title>Sensitivity and Specificity of Peri-Implantitis-Related Parameters: A Case-Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bleeding on probing demonstrated to have high specificity with certain level of sensitivity&#xD;
      to detect periodontal disease. Again, understanding the weak hemidesmosome attachment to the&#xD;
      implant surface is imperative to discern on the probe penetration extent and subsequent&#xD;
      bleeding. In the presence of inflammation, bleeding should be present indicating high&#xD;
      sensitivity when probing deeper sites; nevertheless the lack thereof in healthy condition&#xD;
      does not seem to translate high specificity. In this sense, it is noteworthy to mention that&#xD;
      the mucogingival shift after implant placement often decreases the presence of keratinized&#xD;
      mucosa, triggering a greater inflammatory condition on the peri-implant tissues. Thereupon,&#xD;
      bleeding on probing, although might reliably indicate presence of disease, it does not seem&#xD;
      to be a suitable diagnostic parameter. On the other side, suppuration characterizes the&#xD;
      necrosis of peri-implant tissues, being rich in polymorphonuclear cells and as such, a&#xD;
      sensitive indicator of bone turnover. In this sense, it must be noted that, if detected in&#xD;
      early stages where bone resorption has not occurred yet, it might be a consequence of a&#xD;
      foreign body reaction (i.e., residual cement or floss).&#xD;
&#xD;
      Therefore, in the diagnosis of peri-implantitis, radiographic examination must be always&#xD;
      incorporated to the clinical assessment as the 'gold standard'. Hence, the aim of this&#xD;
      case-control study was to assess the diagnostic accuracy of peri-implantitis-related clinical&#xD;
      parameters compared to otherwise healthy dental implants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All subjects enrolled had to be consecutively evaluated in a routine peri-implant maintenance&#xD;
      t with dental implants for fixed prosthesis rehabilitation with a minimum period of 12 months&#xD;
      after final prosthesis delivery. Patients were contacted and informed to participate in a&#xD;
      cross-sectional assessment to identify the presence of peri-implant diseases. Eligible&#xD;
      implants had to be in an ideal prosthetically driven position, otherwise they were excluded&#xD;
      from the analysis. Moreover, implants that could not be accurately recorded the probing depth&#xD;
      due to inadequate prosthesis design were further excluded. Baseline periapical x-ray at time&#xD;
      of prosthesis delivery was retrospective assessed to exclude implants with early peri-implant&#xD;
      bone loss before function. A detailed description of risk factors and indicators of&#xD;
      peri-implant disease were explained at the same stage. Additionally, patients were thoroughly&#xD;
      instructed on plaque control home care strategies including but not limited to interdental&#xD;
      brushes with nylon-coated core wire, soft toothbrushes (manual and power) and floss with&#xD;
      stiffened end to clean under multiple units fixed-prosthesis. Moreover, treated patients were&#xD;
      encouraged to routinely enroll in a peri-implant maintenance therapy program.&#xD;
&#xD;
      The present case-control study will be conducted in accordance with the Helsinki declaration&#xD;
      of human studies and received approval from the ethics committee from the University of&#xD;
      Extremadura (Badajoz, Spain). An informed written consent was signed from each subject&#xD;
      enrolled in the present study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">April 2, 2017</completion_date>
  <primary_completion_date type="Actual">April 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity to detect peri-implantitis</measure>
    <time_frame>1 year</time_frame>
    <description>Capability to diagnose disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specificity to detect peri-implantitis</measure>
    <time_frame>1 year</time_frame>
    <description>Capability to diagnose health</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">141</enrollment>
  <condition>Sensitivity</condition>
  <condition>Peri-implant Mucositis</condition>
  <condition>Peri-Implantational Loss</condition>
  <condition>Peri-Implantitis</condition>
  <arm_group>
    <arm_group_label>Peri-implantitis</arm_group_label>
    <description>Individuals with implants ≥2mm of radiographic bone loss</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-peri-implantitis patients</arm_group_label>
    <description>Individuals with implants &lt;2mm of radiographic bone loss</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sensitivity test</intervention_name>
    <description>Routine clinical and radiographic examination</description>
    <arm_group_label>Peri-implantitis</arm_group_label>
    <arm_group_label>non-peri-implantitis patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be either approached during their biannual peri-implant maintenance recall&#xD;
        appointment or contacted and asked to participate in a free clinical and radiographic&#xD;
        examination to identify the possible presence of peri-implant pathology.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients within the age range of 18 to 80,&#xD;
&#xD;
          -  non- or light smokers (&lt;10cigarettes/day),&#xD;
&#xD;
          -  no presence of infectious diseases at the time of implant placement or during the&#xD;
             maintenance program,&#xD;
&#xD;
          -  no presence of serious disease or condition known to alter bone metabolism,&#xD;
&#xD;
          -  partial edentulous patients with stable periodontal condition with or without history&#xD;
             of chronic periodontitis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  history of heavy smoking,&#xD;
&#xD;
          -  uncontrolled medical conditions such as diabetes mellitus,&#xD;
&#xD;
          -  not adequate implant position (i.e., prosthetically driven),&#xD;
&#xD;
          -  not properly restored impeding accurate probing depth recording&#xD;
&#xD;
          -  lack of keratinized mucosa&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Florencio Monje Gil</last_name>
    <role>Study Director</role>
    <affiliation>Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Implantologia Cirugia Oral y Maxiofacial</name>
      <address>
        <city>Badajoz</city>
        <zip>06001</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>May 10, 2017</last_update_submitted>
  <last_update_submitted_qc>May 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mucositis</mesh_term>
    <mesh_term>Peri-Implantitis</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_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/NCT03031392
org study id: 18002909/3
nct id: NCT03031392
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Bleeding on probing demonstrated to have high specificity with certain level of sensitivity
      to detect periodontal disease. Again, understanding the weak hemidesmosome attachment to the
      implant surface is imperative to discern on the probe penetration extent and subsequent
      bleeding. In the presence of inflammation, bleeding should be present indicating high
      sensitivity when probing deeper sites; nevertheless the lack thereof in healthy condition
      does not seem to translate high specificity. In this sense, it is noteworthy to mention that
      the mucogingival shift after implant placement often decreases the presence of keratinized
      mucosa, triggering a greater inflammatory condition on the peri-implant tissues. Thereupon,
      bleeding on probing, although might reliably indicate presence of disease, it does not seem
      to be a suitable diagnostic parameter. On the other side, suppuration characterizes the
      necrosis of peri-implant tissues, being rich in polymorphonuclear cells and as such, a
      sensitive indicator of bone turnover. In this sense, it must be noted that, if detected in
      early stages where bone resorption has not occurred yet, it might be a consequence of a
      foreign body reaction (i.e., residual cement or floss).

      Therefore, in the diagnosis of peri-implantitis, radiographic examination must be always
      incorporated to the clinical assessment as the 'gold standard'. Hence, the aim of this
      case-control study was to assess the diagnostic accuracy of peri-implantitis-related clinical
      parameters compared to otherwise healthy dental implants.
All subjects enrolled had to be consecutively evaluated in a routine peri-implant maintenance
      t with dental implants for fixed prosthesis rehabilitation with a minimum period of 12 months
      after final prosthesis delivery. Patients were contacted and informed to participate in a
      cross-sectional assessment to identify the presence of peri-implant diseases. Eligible
      implants had to be in an ideal prosthetically driven position, otherwise they were excluded
      from the analysis. Moreover, implants that could not be accurately recorded the probing depth
      due to inadequate prosthesis design were further excluded. Baseline periapical x-ray at time
      of prosthesis delivery was retrospective assessed to exclude implants with early peri-implant
      bone loss before function. A detailed description of risk factors and indicators of
      peri-implant disease were explained at the same stage. Additionally, patients were thoroughly
      instructed on plaque control home care strategies including but not limited to interdental
      brushes with nylon-coated core wire, soft toothbrushes (manual and power) and floss with
      stiffened end to clean under multiple units fixed-prosthesis. Moreover, treated patients were
      encouraged to routinely enroll in a peri-implant maintenance therapy program.

      The present case-control study will be conducted in accordance with the Helsinki declaration
      of human studies and received approval from the ethics committee from the University of
      Extremadura (Badajoz, Spain). An informed written consent was signed from each subject
      enrolled in the present study.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Sensitivity to detect peri-implantitis
time frame: 1 year
description: Capability to diagnose disease
measure: Specificity to detect peri-implantitis
time frame: 1 year
description: Capability to diagnose health
arm group label: Peri-implantitis
description: Individuals with implants ≥2mm of radiographic bone loss
arm group label: non-peri-implantitis patients
description: Individuals with implants <2mm of radiographic bone loss
intervention type: Diagnostic Test
intervention name: Sensitivity test
description: Routine clinical and radiographic examination
arm group label: Peri-implantitis
arm group label: non-peri-implantitis patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Florencio Monje Gil
role: Study Director
affiliation: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Mucositis
mesh term: Peri-Implantitis
mesh term: Hypersensitivity
sharing ipd: No