<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/NCT02219139</url>
  </required_header>
  <id_info>
    <org_study_id>CR 03/10 ESTA</org_study_id>
    <secondary_id>CIV-12-10-009101</secondary_id>
    <nct_id>NCT02219139</nct_id>
  </id_info>
  <brief_title>A Comparative, Randomized, Prospective, Performance Evaluation of Abutments in Single Tooth Gaps</brief_title>
  <official_title>A Comparative, Randomized, Prospective, Clinical Pilot Study to Evaluate the Performance of Modified Study Abutments in Single Tooth Gaps</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Straumann AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Straumann AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Immunologically evaluation of myeloperoxidase level as indicator for inflammatory reactions&#xD;
      on modified surface abutments compared to machined surface abutments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will&#xD;
      be asked to stop oral hygiene at the study site for 2 weeks.&#xD;
&#xD;
      Sulcus fluid and plaque samples will be taken at the abutment site at several visits before&#xD;
      and during abdication of oral hygiene.&#xD;
&#xD;
      The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the&#xD;
      patients will be treated according to the standard protocol of the clinic to obtain their&#xD;
      final restoration&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No patients could be recruited&#xD;
  </why_stopped>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of Myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments.</measure>
    <time_frame>Inflammation assessment and biopsy at study day 70.</time_frame>
    <description>A biopsy will be taken at study day 70. The study abutment will be removed together with a small slice of the surrounding soft tissue to histologically evaluation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of myeloperoxidase level of modified surface abutments compared to machined surface abutment at visit 2, 3, 4, and 6.</measure>
    <time_frame>20-24 weeks</time_frame>
    <description>A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evaluation of inflammatory parameters of modified surface abutment compared to machined surface abutments</measure>
    <time_frame>20-24 weeks</time_frame>
    <description>A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of clinical inflammatory parameters of modified surface abutments compared to machined surface abutments based on modified Mombelli plaque index and modified Lobene gingival index.</measure>
    <time_frame>20-24 weeks</time_frame>
    <description>A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of subgingival plaque extension of modified surface abutments compared to machined surface abutments</measure>
    <time_frame>9 weeks after abutment placement</time_frame>
    <description>Patients will be asked to suspend oral hygiene in the area of the abutment. after 42-49 days after abutment placement for 14 days. At study week 8 a histological sample will be taken</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of soft tissue around the abutment of modified surface abutment compared to machined surface abutments</measure>
    <time_frame>At 8 weeks after abutment placement</time_frame>
    <description>8 weeks after abutment placement patients have been asked for 14 days of abdication of oral hygiene. A histological sample will be taken then.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of bacterial community at the abutment site</measure>
    <time_frame>28 days</time_frame>
    <description>At study day 42-49, day 49-56, day 56-63, and day 77-105 a microbiological sample will be taken</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Tooth Loss</condition>
  <arm_group>
    <arm_group_label>ESTA abutment Roxolid</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>One study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will be asked to stop oral hygiene at the study site for 2 weeks.&#xD;
Sulcus fluid and plaque samples will be taken at the abutment site at several visits before and during abdication of oral hygiene.&#xD;
The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the patients will be treated according to the standard protocol of the clinic to obtain their final restoration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ESTA abutment Roxolid</intervention_name>
    <description>Enhanced Soft Tissue Attachment surface on Roxolid or machined surface on Roxolid abutment placement.</description>
    <arm_group_label>ESTA abutment Roxolid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have voluntary signed the informed consent form before any study related&#xD;
             action.&#xD;
&#xD;
          -  Males and females with at least 18 years of age&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Straumann bone level implant (healed for at least 4 weeks) in a tooth gap in the&#xD;
             maxilla or mandible with thick tissue biotype&#xD;
&#xD;
          -  Adequate oral hygiene (Full mouth plaque index; O'Leary, et al. 1972) &lt;25% at abutment&#xD;
             placement&#xD;
&#xD;
          -  The patient must be able to open the mouth to allow removal of the abutment at the&#xD;
             planned abutment site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled&#xD;
             diabetes)&#xD;
&#xD;
          -  Any antibiotic treatment or anti-inflammatory treatment within the past 2 month&#xD;
&#xD;
          -  Any contraindications for oral surgical procedures&#xD;
&#xD;
          -  Mucosal diseases (e.g. lichen planus, mouth ulcer)&#xD;
&#xD;
          -  History of local irradiation therapy&#xD;
&#xD;
          -  Current treated (within the last 12 month) or untreated periodontitis&#xD;
&#xD;
          -  Current treated (within the last 6 month) or untreated gingivitis&#xD;
&#xD;
          -  Probing pocket depth of ≥4 mm on one of the teeth immediately adjacent to the dental&#xD;
             implant site&#xD;
&#xD;
          -  Severe bruxing or clenching habits&#xD;
&#xD;
          -  Lack of primary stability of the implant at abutment placement&#xD;
&#xD;
          -  Subjects who have undergone administration of any investigational device within 30&#xD;
             days of enrolment in the study&#xD;
&#xD;
          -  Conditions or circumstances, in the opinion of the investigator, which would prevent&#xD;
             completion of study participation or interfere with analysis of study results, such as&#xD;
             history of non-compliance or unreliability&#xD;
&#xD;
          -  Physical or mental handicaps that would interfere with the ability to follow protocol&#xD;
             procedures&#xD;
&#xD;
          -  Pregnant or breastfeeding wome&#xD;
&#xD;
          -  Insufficient soft tissue attachment to the neck of the abutment (e.g. visibility of&#xD;
             the abutment platform or exposed ESTAnsurface) after abutment placement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anton Sculean, Dr med dent</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Bern, Zahnmedizinische Kliniken Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universität Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>March 2, 2016</last_update_submitted>
  <last_update_submitted_qc>March 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Edentulous</keyword>
  <keyword>Roxolid</keyword>
  <keyword>SLAclive surface</keyword>
  <keyword>Titanium/zirconium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth Loss</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/NCT02219139
org study id: CR 03/10 ESTA
secondary id: CIV-12-10-009101
nct id: NCT02219139
lead sponsor: 
has dmc: No
Immunologically evaluation of myeloperoxidase level as indicator for inflammatory reactions
      on modified surface abutments compared to machined surface abutments.
One study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will
      be asked to stop oral hygiene at the study site for 2 weeks.

      Sulcus fluid and plaque samples will be taken at the abutment site at several visits before
      and during abdication of oral hygiene.

      The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the
      patients will be treated according to the standard protocol of the clinic to obtain their
      final restoration
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Evaluation of Myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments.
time frame: Inflammation assessment and biopsy at study day 70.
description: A biopsy will be taken at study day 70. The study abutment will be removed together with a small slice of the surrounding soft tissue to histologically evaluation.
measure: Evaluation of myeloperoxidase level of modified surface abutments compared to machined surface abutment at visit 2, 3, 4, and 6.
time frame: 20-24 weeks
description: A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.
measure: evaluation of inflammatory parameters of modified surface abutment compared to machined surface abutments
time frame: 20-24 weeks
description: A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.
measure: Evaluation of clinical inflammatory parameters of modified surface abutments compared to machined surface abutments based on modified Mombelli plaque index and modified Lobene gingival index.
time frame: 20-24 weeks
description: A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.
measure: Evaluation of subgingival plaque extension of modified surface abutments compared to machined surface abutments
time frame: 9 weeks after abutment placement
description: Patients will be asked to suspend oral hygiene in the area of the abutment. after 42-49 days after abutment placement for 14 days. At study week 8 a histological sample will be taken
measure: Evaluation of soft tissue around the abutment of modified surface abutment compared to machined surface abutments
time frame: At 8 weeks after abutment placement
description: 8 weeks after abutment placement patients have been asked for 14 days of abdication of oral hygiene. A histological sample will be taken then.
measure: Evaluation of bacterial community at the abutment site
time frame: 28 days
description: At study day 42-49, day 49-56, day 56-63, and day 77-105 a microbiological sample will be taken
arm group label: ESTA abutment Roxolid
arm group type: Other
description: One study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will be asked to stop oral hygiene at the study site for 2 weeks.
Sulcus fluid and plaque samples will be taken at the abutment site at several visits before and during abdication of oral hygiene.
The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the patients will be treated according to the standard protocol of the clinic to obtain their final restoration.
intervention type: Device
intervention name: ESTA abutment Roxolid
description: Enhanced Soft Tissue Attachment surface on Roxolid or machined surface on Roxolid abutment placement.
arm group label: ESTA abutment Roxolid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anton Sculean, Dr med dent
role: Principal Investigator
affiliation: University Bern, Zahnmedizinische Kliniken Bern
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Tooth Loss
sharing ipd: No