<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/NCT03766022</url>
  </required_header>
  <id_info>
    <org_study_id>CTIL-0418-18-RMB</org_study_id>
    <nct_id>NCT03766022</nct_id>
  </id_info>
  <brief_title>Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Clinical Trial</brief_title>
  <official_title>Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</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>
      The Aim of this study randomized prospective clinical trial is to examine and compare&#xD;
      periimplant tissue changes between heavy smokers and non-smokers at 12 months post loading&#xD;
      using the alpha Bio Neo standard diameter implants with conical abutment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peri-implant marginal bone level is one of the most important references criteria to monitor&#xD;
      peri-implant health.A radiographically measured marginal bone loss of up to 1.5 mm during the&#xD;
      first year of loading, followed by a marginal bone loss of up to 0.2 mm for each succeeding&#xD;
      year, is an acceptable criterion to determine implant success.&#xD;
&#xD;
      Smoking has been implicated in many adverse systemic outcomes, including tooth loss, alveolar&#xD;
      bone loss and dental implant failure.&#xD;
&#xD;
      Platform switching, also known as platform shifting, is whenever an abutment is used that is&#xD;
      smaller in diameter than the implant platform. Platform switching can help prevent crestal&#xD;
      bone loss.&#xD;
&#xD;
      The hypothesis of the present study is that the use of conical abutment might reduce marginal&#xD;
      bone loss around dental implants in both smokers and non-smokers alike.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">April 2024</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>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>marginal bone loss</measure>
    <time_frame>6 months and 18 months after implantation.</time_frame>
    <description>Standardized periapical radiographs will be used to assess changes in radiographic bone height.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implants probing depth (IPD)</measure>
    <time_frame>4 months, 6 months and 16 months after implantation</time_frame>
    <description>will be measured by inserting a probe to the gingival pocket at six sites around implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing</measure>
    <time_frame>4 months, 6 months and 16 months after implantation</time_frame>
    <description>will be measured by inserting a probe to the gingival pocket at six sites around each implant: Dichotomic measurments: Yes/No</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Labial gingival recession</measure>
    <time_frame>4 months, 6 months and 16 months after implantation</time_frame>
    <description>will be measured using the incisal edge. occlusal plan as a fixed reference point.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Implant stability</measure>
    <time_frame>Immediatly after implant installation (day 0) and 4 months after implantation</time_frame>
    <description>Osstel measurements</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Dental Implants,Peri-implantitis,Smoking</condition>
  <arm_group>
    <arm_group_label>Heavy smoker patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non Smokers patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neo dental implant Alpha Bio Tec. Ltd.</intervention_name>
    <description>Neo dental implant is used to restore missing teeth</description>
    <arm_group_label>Heavy smoker patients</arm_group_label>
    <arm_group_label>non Smokers patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 20 - 85 years.&#xD;
&#xD;
          2. Written informed consent.&#xD;
&#xD;
          3. In need for a dental implant Adequate alveolar bone Intended to be restored with&#xD;
             individual crowns.&#xD;
&#xD;
          4. Heavy smokers (20 Cig/d &gt; 5years) or non / former smokers (&gt; 5 years since cessation).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active periodontal disease.&#xD;
&#xD;
          2. Systemic condition and medication that may affect soft and hard tissue.&#xD;
&#xD;
          3. healing Parafunctional occlusal scheme and habits.&#xD;
&#xD;
          4. Pregnancy or intention to become pregnant in the following twelve months.&#xD;
&#xD;
          5. Patient not willing or able to meet the study schedule.&#xD;
&#xD;
          6. Patient in need for simultaneous bone graft or GBR using a membrane barrier.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hadar Zigdon, DMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Campus</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hadar Zigdon, DMD</last_name>
    <phone>9727772983</phone>
    <email>h_zigdon@rambam.health.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yaniv Mayer, DMD</last_name>
    <phone>9727772983</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rambam Hospital</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eli Machtei</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>April 2, 2023</last_update_submitted>
  <last_update_submitted_qc>April 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</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>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/NCT03766022
org study id: CTIL-0418-18-RMB
nct id: NCT03766022
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Aim of this study randomized prospective clinical trial is to examine and compare
      periimplant tissue changes between heavy smokers and non-smokers at 12 months post loading
      using the alpha Bio Neo standard diameter implants with conical abutment.
Peri-implant marginal bone level is one of the most important references criteria to monitor
      peri-implant health.A radiographically measured marginal bone loss of up to 1.5 mm during the
      first year of loading, followed by a marginal bone loss of up to 0.2 mm for each succeeding
      year, is an acceptable criterion to determine implant success.

      Smoking has been implicated in many adverse systemic outcomes, including tooth loss, alveolar
      bone loss and dental implant failure.

      Platform switching, also known as platform shifting, is whenever an abutment is used that is
      smaller in diameter than the implant platform. Platform switching can help prevent crestal
      bone loss.

      The hypothesis of the present study is that the use of conical abutment might reduce marginal
      bone loss around dental implants in both smokers and non-smokers alike.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: marginal bone loss
time frame: 6 months and 18 months after implantation.
description: Standardized periapical radiographs will be used to assess changes in radiographic bone height.
measure: Implants probing depth (IPD)
time frame: 4 months, 6 months and 16 months after implantation
description: will be measured by inserting a probe to the gingival pocket at six sites around implant
measure: Bleeding on probing
time frame: 4 months, 6 months and 16 months after implantation
description: will be measured by inserting a probe to the gingival pocket at six sites around each implant: Dichotomic measurments: Yes/No
measure: Labial gingival recession
time frame: 4 months, 6 months and 16 months after implantation
description: will be measured using the incisal edge. occlusal plan as a fixed reference point.
measure: Implant stability
time frame: Immediatly after implant installation (day 0) and 4 months after implantation
description: Osstel measurements
arm group label: Heavy smoker patients
arm group type: Experimental
description: Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd.
arm group label: non Smokers patients
arm group type: Active Comparator
description: Marginal bone changes after 1 year after implant installation using Neo dental implant Alpha Bio Tec. Ltd.
intervention type: Device
intervention name: Neo dental implant Alpha Bio Tec. Ltd.
description: Neo dental implant is used to restore missing teeth
arm group label: Heavy smoker patients
arm group label: non Smokers patients
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hadar Zigdon, DMD
role: Principal Investigator
affiliation: Rambam Health Care Campus
last name: Hadar Zigdon, DMD
phone: 9727772983
email: h_zigdon@rambam.health.gov.il
last name: Yaniv Mayer, DMD
phone: 9727772983
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Peri-Implantitis