<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/NCT02184845</url>
  </required_header>
  <id_info>
    <org_study_id>T 176</org_study_id>
    <nct_id>NCT02184845</nct_id>
  </id_info>
  <brief_title>A 5 Year Clinical Study on NobelActive 3 mm Implants</brief_title>
  <acronym>NA 3 MM</acronym>
  <official_title>Open, Prospective, Single Cohort, Multi-centre Study Evaluating the NobelActive 3 mm Implant Immediately Restored With Single Crowns in the Maxillary Lateral Incisor Area or Mandibular Central or Lateral Incisor Area</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nobel Biocare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nobel Biocare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multi-centre study evaluating the NobelActive 3.0 mm implant immediately restored with single&#xD;
      crowns in the maxillary lateral incisor area or mandibular central or lateral incisor area.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">March 5, 2020</completion_date>
  <primary_completion_date type="Actual">March 5, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Marginal bone level changes</measure>
    <time_frame>5 years</time_frame>
    <description>Marginal bone level changes over time around the NobelActive 3.0 mm implant</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Single Tooth Implant</condition>
  <arm_group>
    <arm_group_label>NobelActive 3.0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implant NobelActive 3.0</intervention_name>
    <arm_group_label>NobelActive 3.0</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obtained informed consent from the subject.&#xD;
&#xD;
          -  The subject shall be at least 18 years of age and have passed secession of growth.&#xD;
&#xD;
          -  The subject shall be in need of one or more single tooth implant supported&#xD;
             restoration(s) in the maxillary lateral incisor or mandibular central or lateral&#xD;
             incisor areas of the mouth.&#xD;
&#xD;
          -  The subject shall have natural tooth roots present on both sides adjacent to the&#xD;
             implant position.&#xD;
&#xD;
          -  The subject must be in such a physical and mental condition that a 5-year follow-up&#xD;
             period can be carried out without foreseeable problems.&#xD;
&#xD;
          -  The subject shall have sufficient bone volume at the implant site for placing a&#xD;
             NobelActive 3.0 mm implant with a length of at least 10 mm.&#xD;
&#xD;
          -  The subject as well as the implant site shall fulfill criteria for immediate&#xD;
             provisionalization within 24 hours. A minimum insertion torque of 35 Ncm without&#xD;
             further rotation is required.&#xD;
&#xD;
          -  The implant site shall be free from tooth remnants.&#xD;
&#xD;
          -  If the implant is placed in an extraction site, the extraction socket should have at&#xD;
             least 3 intact walls. A dehiscence defect of up to 3 mm is permitted on the fourth&#xD;
             wall.&#xD;
&#xD;
          -  If the implant is placed in an extraction site, proper and thorough debridement of the&#xD;
             extraction socket should be performed.&#xD;
&#xD;
          -  The subject shall be healthy and compliant with good oral hygiene.&#xD;
&#xD;
          -  The subject shall have a favorable and stable occlusal relationship.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is not able to give her/his informed consent of participating&#xD;
&#xD;
          -  Health conditions, which do not permit the surgical treatment.&#xD;
&#xD;
          -  Reason to believe that the treatment might have a negative effect on the subject's&#xD;
             total situation (psychiatric problems), as noted in subject records or in subject&#xD;
             history.&#xD;
&#xD;
          -  Any disorders in the planned implant area such as previous tumours, chronic bone&#xD;
             disease or previous irradiation.&#xD;
&#xD;
          -  Teeth in positions adjacent to the implant site with ongoing infections, endodontic or&#xD;
             peri-odontal problems.&#xD;
&#xD;
          -  Alcohol or drug abuse as noted in subject records or in subject history.&#xD;
&#xD;
          -  Heavy smoking (&gt;10 cigarettes/day).&#xD;
&#xD;
          -  Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of&#xD;
             neglecting doctor's recommendations regarding treatment, food and alcohol intake.&#xD;
&#xD;
          -  Any other disease or medication that might have an influence on the involved tissues,&#xD;
             such as intake of bisphosphonates, treatment with heparine, osteogenesis imperfecta,&#xD;
             osteoporosis etc.&#xD;
&#xD;
          -  Severe bruxism or other destructive habits.&#xD;
&#xD;
          -  If the implant is not able to withstand a final torque of 35 Ncm without further&#xD;
             rotation, or if the implant for any other reason cannot be immediately&#xD;
             provisionalized, as judged by the clinician, the implant will be excluded from the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>Switzerland</country>
  </removed_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>single tooth implant</keyword>
  <keyword>supported restoration(s)</keyword>
  <keyword>maxillary lateral incisor</keyword>
  <keyword>mandibular central incisor</keyword>
  <keyword>lateral incisor</keyword>
  <keyword>areas of the mouth</keyword>
  <!-- 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/NCT02184845
org study id: T 176
nct id: NCT02184845
lead sponsor: 
has dmc: No
is fda regulated drug: No
Multi-centre study evaluating the NobelActive 3.0 mm implant immediately restored with single
      crowns in the maxillary lateral incisor area or mandibular central or lateral incisor area.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Marginal bone level changes
time frame: 5 years
description: Marginal bone level changes over time around the NobelActive 3.0 mm implant
arm group label: NobelActive 3.0
arm group type: Experimental
intervention type: Device
intervention name: Implant NobelActive 3.0
arm group label: NobelActive 3.0
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
country: Switzerland
responsible party type: Sponsor