<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/NCT04415801</url>
  </required_header>
  <id_info>
    <org_study_id>3/20</org_study_id>
    <nct_id>NCT04415801</nct_id>
  </id_info>
  <brief_title>Effect of Repeated Removal and Re-placement of Abutments Around Dental Implants</brief_title>
  <official_title>Effect of Repeated Removal and Re-placement of Laser Microgrooved and Machined Abutments on Proinflammatory Cytokine Levels Around Dental Implants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Repeated removal and re-placement of healing and prosthetic abutments result in frequent&#xD;
      injuries to the soft tissues. The purpose was to evaluate the effect of repeated removal and&#xD;
      re-placement of laser microgrooved and smooth/machined healing and prosthetic abutments&#xD;
      during restorative stages, and 1 year after functional loading, on proinflammatory cytokine&#xD;
      levels around dental implants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty-four patients each received 2 one-stage implants in a split mouth design on the same&#xD;
      jaw. In each patient one healing and prosthetic abutments with a laser microgrooved surface&#xD;
      (LMS group) and one healing and prosthetic abutments with smooth/machined surface (S/MS&#xD;
      group) were used. Four months following implant placement [Baseline (BSL)], the healing&#xD;
      abutments were disconnnected and reconnected three times to carry out the impression&#xD;
      procedures and metal framework try-in. Four weeks later (T0), definitive prosthetic abutments&#xD;
      were installated with screw retained crowns. Samples for immunological analyses were taken&#xD;
      from the sulcus around each implant at BSL, T0, and 1 year after functional loading (T1).&#xD;
      Peri-implant crevicular fluid samples were analyzed for interleukin-1beta (IL-1β),&#xD;
      interleukin-6 (IL-6) and tumor necrosis factor (TNF)-α levels using the ELISA kit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline to 8 weeks of gingival fluid production</measure>
    <time_frame>8 weeks</time_frame>
    <description>The gingival fluid production was measured electronically in Periotron units, (Periotron 8000®, Ora Flow, Inc., Plainview, NY, USA) which were converted to microliters (μl) by MCCONVRT software (Ora Flow).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Peri-implant Mucositis</condition>
  <arm_group>
    <arm_group_label>Implant abutments</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>implant abutments</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Repeated removal and re-placement of healing and prosthetic abutments</intervention_name>
    <description>Repeated removal and re-placement of healing and prosthetic abutments</description>
    <arm_group_label>Implant abutments</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older, in good general health, and with sufficient amount of bone&#xD;
             available to place a standard implant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  natural teeth adjacent to surgical area affected by untreated periodontal or&#xD;
             endodontic infections, peri-implant bone defects requiring bone augmentation, absence&#xD;
             of opposing occlusion,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renzo Guarnieri</last_name>
    <role>Principal Investigator</role>
    <affiliation>University La Sapienza Roma Italy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Renzo Guarnieri, MD DDS</last_name>
    <phone>+39 3425224458</phone>
    <email>renzoguarnieri@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Renzo Guarnieri</last_name>
    <email>renzoguarnieri@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universita la Sapienza</name>
      <address>
        <city>Roma</city>
        <zip>00100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Renzi Guarnieri, MD DDS</last_name>
      <phone>+39 342 5224458</phone>
      <email>renzoguarnieri@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Renzo Guarnieri</investigator_full_name>
    <investigator_title>Adjunct Professor</investigator_title>
  </responsible_party>
  <keyword>Peri-implant Mucositis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mucositis</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/NCT04415801
org study id: 3/20
nct id: NCT04415801
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Repeated removal and re-placement of healing and prosthetic abutments result in frequent
      injuries to the soft tissues. The purpose was to evaluate the effect of repeated removal and
      re-placement of laser microgrooved and smooth/machined healing and prosthetic abutments
      during restorative stages, and 1 year after functional loading, on proinflammatory cytokine
      levels around dental implants.
Twenty-four patients each received 2 one-stage implants in a split mouth design on the same
      jaw. In each patient one healing and prosthetic abutments with a laser microgrooved surface
      (LMS group) and one healing and prosthetic abutments with smooth/machined surface (S/MS
      group) were used. Four months following implant placement [Baseline (BSL)], the healing
      abutments were disconnnected and reconnected three times to carry out the impression
      procedures and metal framework try-in. Four weeks later (T0), definitive prosthetic abutments
      were installated with screw retained crowns. Samples for immunological analyses were taken
      from the sulcus around each implant at BSL, T0, and 1 year after functional loading (T1).
      Peri-implant crevicular fluid samples were analyzed for interleukin-1beta (IL-1β),
      interleukin-6 (IL-6) and tumor necrosis factor (TNF)-α levels using the ELISA kit.
intervention model: Sequential Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: change from baseline to 8 weeks of gingival fluid production
time frame: 8 weeks
description: The gingival fluid production was measured electronically in Periotron units, (Periotron 8000®, Ora Flow, Inc., Plainview, NY, USA) which were converted to microliters (μl) by MCCONVRT software (Ora Flow).
arm group label: Implant abutments
arm group type: Experimental
description: implant abutments
intervention type: Diagnostic Test
intervention name: Repeated removal and re-placement of healing and prosthetic abutments
description: Repeated removal and re-placement of healing and prosthetic abutments
arm group label: Implant abutments
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Renzo Guarnieri
role: Principal Investigator
affiliation: University La Sapienza Roma Italy
last name: Renzo Guarnieri, MD DDS
phone: +39 3425224458
email: renzoguarnieri@gmail.com
last name: Renzo Guarnieri
email: renzoguarnieri@gmail.com
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Renzo Guarnieri
investigator title: Adjunct Professor
mesh term: Mucositis
sharing ipd: No