<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/NCT04421066</url>
  </required_header>
  <id_info>
    <org_study_id>18-101718</org_study_id>
    <nct_id>NCT04421066</nct_id>
  </id_info>
  <brief_title>Histological, Genetic and Epigenetic Analysis of Procedures Related With Dental Implants</brief_title>
  <official_title>Histological, Genetic and Epigenetic Analysis of Procedures Related With Dental Implants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Simón Pardiñas López</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital A Coruña</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto de Investigacion Biomedica de A Coruna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacion Clinica Pardinas</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>
      In this study genomic, proteomic and histological technologies for the search and&#xD;
      characterization of epigenetic modifications and molecular or protein markers, useful in the&#xD;
      diagnosis and progression of peri-implant diseases and prevention of implant failure will be&#xD;
      used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Samples stored at the Biomedical Research Institute of A Coruña, Xerencia Integrated&#xD;
      Management of A Coruña (University Hospital Center of A Coruña), belonging to the collection&#xD;
      of the line of research &quot;Oral Health and Systemic Relationship&quot; with registration nº 2017/104&#xD;
      will be used for the realization of the present study.&#xD;
&#xD;
      Nucleic acid extraction and histological analysis of the samples will be performed to&#xD;
      evaluate the functional epigenetic modifications associated with peri-implant diseases, in an&#xD;
      exploratory manner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 29, 2019</start_date>
  <completion_date type="Anticipated">December 20, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 21, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Differences in histological characteristics in peri-implantitis subjects compared to healthy subjects, ie, presence and amount of inflammatory cells and bacteria.</measure>
    <time_frame>1 day</time_frame>
    <description>Gingival and blood samples collected from healthy subjects and subjects with peri-implantitis (including failing implants) will be used to determinate histological characteristics associated with peri-implantitis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in epigenetic characteristics analyzing DNA methylation in peri-implantitis subjects compared to healthy subjects.</measure>
    <time_frame>1 day</time_frame>
    <description>Gingival and blood samples collected from healthy subjects and subjects with peri-implantitis (including failing implants) will be used to determinate epigenetic characteristics associated with peri-implantitis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relation between peri-implant diseases and epigenetic modifications in terms of periodontal pocket depth.</measure>
    <time_frame>1 day</time_frame>
    <description>To determine whether periodontal measurements PPD (in mm) are associated with epigenetic modifications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between peri-implant diseases and epigenetic modifications in terms of bleeding on probing.</measure>
    <time_frame>1 day</time_frame>
    <description>To determine whether periodontal measurements bleeding on probing (BOP) (measured in percentage), are associated with epigenetic modifications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between peri-implant diseases and epigenetic modifications in terms of clinical attachment level.</measure>
    <time_frame>1 day</time_frame>
    <description>To determine whether periodontal measurements CAL (clinical insertion level in mm), are associated with epigenetic modifications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between peri-implant diseases and epigenetic modifications in terms of plaque index.</measure>
    <time_frame>1 day</time_frame>
    <description>To determine whether periodontal measurements plaque index (Sillness &amp; Loe index)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported outcome measures.</measure>
    <time_frame>1 day</time_frame>
    <description>To determine whether patient-reported outcome measures (PROMs) are related to histological and epigenetic outcomes.&#xD;
Oral Health Impact Profile-14 (OHIP-14) assessed at study visit.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Peri-Implantitis</condition>
  <condition>Peri-implant Mucositis</condition>
  <condition>Implant Complication</condition>
  <condition>Implant Tissue Failure</condition>
  <arm_group>
    <arm_group_label>Peri-implantitis</arm_group_label>
    <description>Patients with at least one dental implant diagnosed with peri-implantitis undergoing treatment for peri-implantitis as their standard of care will be included in this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <description>Patients with general good health and health gingiva undergoing extraction of wisdom tooth will be included in this study group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gingival and bone sample collection</intervention_name>
    <description>Gingival and bone samples will be collected from the sites affected by peri-implantitis during their surgical treatment of peri-implantitis or histological and epigenetic analysis.</description>
    <arm_group_label>Peri-implantitis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Healthy individuals</intervention_name>
    <description>Gingival and bone samples will be collected from the extraction sites for histological and epigenetic analysis.</description>
    <arm_group_label>Healthy</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Gingival and bone samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        -  Periodontally Healthy Subjects&#xD;
&#xD;
          -  Peri-implantitis Subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subjects must have read, understood and signed an informed consent regarding the&#xD;
             obtaining of biological samples and participation in the research line of &quot;Oral Health&#xD;
             and Systemic Relationship&quot; existing in the Pardiñas Dental Medical Clinic and approved&#xD;
             by the ethical committee.&#xD;
&#xD;
          -  The subjects must be between 20-90 years of age.&#xD;
&#xD;
          -  Subjects must be non-smokers or former smokers who have quit smoking for at least one&#xD;
             year prior to enrollment in the study.&#xD;
&#xD;
        In addition to the general criteria listed, samples of a healthy periodontal subject must&#xD;
        meet the following criteria when reviewing their medical and dental history :&#xD;
&#xD;
        -Subjects do not have or have had a history of periodontal disease, as described in the &quot;&#xD;
        2017 World Workshop on the Classification of Periodontal and Peri- Implant Diseases and&#xD;
        Conditions &quot;&#xD;
&#xD;
        Samples from a subject with peri-implant disease must meet the following criteria:&#xD;
&#xD;
        -Samples of subjects who have at least one implant - supported prosthesis for at least 12&#xD;
        months and affected by peri- implant disease according to the &quot; 2017 World Workshop on the&#xD;
        Classification of Periodontal and Peri-Implant Diseases and Conditions &quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Samples of pregnant or lactating women at the time of collection.&#xD;
&#xD;
          -  Samples of subjects who were taking antibiotics within 1 month before collection of&#xD;
             the sample.&#xD;
&#xD;
          -  Samples of subjects with chronic use of non-steroidal anti-inflammatory drugs for more&#xD;
             than 3 weeks at the time of sample collection. The use of aspirin in low doses (≤81 mg&#xD;
             / day) will be allowed .&#xD;
&#xD;
          -  Samples from subjects with disease in the mucosa in the area located around the site&#xD;
             of sample collection.&#xD;
&#xD;
          -  Samples of subjects with a systemic disease that would exclude the analysis (for&#xD;
             example, severe medical problems, bone metabolism disorders, uncontrolled bleeding&#xD;
             disorders, depressed immune system, diseases that require the periodic use of&#xD;
             steroids, uncontrolled endocrine disorders) .&#xD;
&#xD;
          -  Samples of subjects with a history of local irradiation therapy in the head / neck&#xD;
             area.&#xD;
&#xD;
          -  Samples of subjects with a history of having received treatment with intravenous or&#xD;
             subcutaneous antiresorptive agents associated with osteonecrosis of the jaw, such as&#xD;
             bisphosphonates.&#xD;
&#xD;
        Samples of subjects assigned to the healthy group that meet any of the following criteria&#xD;
        will be excluded from participation in this study:&#xD;
&#xD;
          -  Root fragments, pericoronaritis, endo-perio lesions, dental abscesses at the site of&#xD;
             the biopsy.&#xD;
&#xD;
          -  Presence of BOP in the sample collection site.&#xD;
&#xD;
        Peri- implant disease samples / Exclusion of Subjects&#xD;
&#xD;
        The samples of the subjects assigned to the peri- implant diseases group that meet any of&#xD;
        the following criteria will be excluded from participation in this study if the implants&#xD;
        were removed due to:&#xD;
&#xD;
          -  Inadequate position of the implant.&#xD;
&#xD;
          -  Subjects with implants previously treated surgically for peri- implant disease with&#xD;
             antibiotics.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simón Pardiñas López, DDS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundación Clínica Pardiñas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fundacion Clinica Pardiñas</name>
      <address>
        <city>A Coruña</city>
        <state>Galicia</state>
        <zip>15003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>August 18, 2021</last_update_submitted>
  <last_update_submitted_qc>August 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fundacion Clinica Pardinas</investigator_affiliation>
    <investigator_full_name>Simón Pardiñas López</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04421066
org study id: 18-101718
nct id: NCT04421066
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study genomic, proteomic and histological technologies for the search and
      characterization of epigenetic modifications and molecular or protein markers, useful in the
      diagnosis and progression of peri-implant diseases and prevention of implant failure will be
      used.
Samples stored at the Biomedical Research Institute of A Coruña, Xerencia Integrated
      Management of A Coruña (University Hospital Center of A Coruña), belonging to the collection
      of the line of research "Oral Health and Systemic Relationship" with registration nº 2017/104
      will be used for the realization of the present study.

      Nucleic acid extraction and histological analysis of the samples will be performed to
      evaluate the functional epigenetic modifications associated with peri-implant diseases, in an
      exploratory manner.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Differences in histological characteristics in peri-implantitis subjects compared to healthy subjects, ie, presence and amount of inflammatory cells and bacteria.
time frame: 1 day
description: Gingival and blood samples collected from healthy subjects and subjects with peri-implantitis (including failing implants) will be used to determinate histological characteristics associated with peri-implantitis.
measure: Differences in epigenetic characteristics analyzing DNA methylation in peri-implantitis subjects compared to healthy subjects.
time frame: 1 day
description: Gingival and blood samples collected from healthy subjects and subjects with peri-implantitis (including failing implants) will be used to determinate epigenetic characteristics associated with peri-implantitis.
measure: Relation between peri-implant diseases and epigenetic modifications in terms of periodontal pocket depth.
time frame: 1 day
description: To determine whether periodontal measurements PPD (in mm) are associated with epigenetic modifications.
measure: Relation between peri-implant diseases and epigenetic modifications in terms of bleeding on probing.
time frame: 1 day
description: To determine whether periodontal measurements bleeding on probing (BOP) (measured in percentage), are associated with epigenetic modifications.
measure: Relation between peri-implant diseases and epigenetic modifications in terms of clinical attachment level.
time frame: 1 day
description: To determine whether periodontal measurements CAL (clinical insertion level in mm), are associated with epigenetic modifications.
measure: Relation between peri-implant diseases and epigenetic modifications in terms of plaque index.
time frame: 1 day
description: To determine whether periodontal measurements plaque index (Sillness & Loe index)
measure: Patient-reported outcome measures.
time frame: 1 day
description: To determine whether patient-reported outcome measures (PROMs) are related to histological and epigenetic outcomes.
Oral Health Impact Profile-14 (OHIP-14) assessed at study visit.
arm group label: Peri-implantitis
description: Patients with at least one dental implant diagnosed with peri-implantitis undergoing treatment for peri-implantitis as their standard of care will be included in this study.
arm group label: Healthy
description: Patients with general good health and health gingiva undergoing extraction of wisdom tooth will be included in this study group.
intervention type: Procedure
intervention name: Gingival and bone sample collection
description: Gingival and bone samples will be collected from the sites affected by peri-implantitis during their surgical treatment of peri-implantitis or histological and epigenetic analysis.
arm group label: Peri-implantitis
intervention type: Procedure
intervention name: Healthy individuals
description: Gingival and bone samples will be collected from the extraction sites for histological and epigenetic analysis.
arm group label: Healthy
Gingival and bone samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Simón Pardiñas López, DDS, MS
role: Principal Investigator
affiliation: Fundación Clínica Pardiñas
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Fundacion Clinica Pardinas
investigator full name: Simón Pardiñas López
investigator title: Director
mesh term: Mucositis
mesh term: Peri-Implantitis
sharing ipd: Undecided