<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/NCT01720420</url>
  </required_header>
  <id_info>
    <org_study_id>T-174</org_study_id>
    <nct_id>NCT01720420</nct_id>
  </id_info>
  <brief_title>A Clinical Evaluation of NobelProcera Implant Bar Overdenture</brief_title>
  <official_title>A Clinical Evaluation of NobelProceraTM Implant Bar Overdenture in the Mandible or Maxilla on 4 NobelReplaceTM CC Implants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nobel Biocare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nobel Biocare</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      AN OPEN 5-YEAR PROSPECTIVE, CLINICAL MULTI-CENTER STUDY on NobelProcera Implant Bar Titanium&#xD;
      with Locator attachment and related Overdenture on 4 NobelReplace implants with conical&#xD;
      connection (CC) in the mandible/maxilla.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study centers: 8 centers in 4 countries&#xD;
&#xD;
      Objectives of the study:&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      To evaluate and compare the clinical marginal bone level change (MBL) around the&#xD;
      NobelReplaceTM CC implants supporting NobelProceraTM Implant Bar Overdenture&#xD;
      (fixed-removable) in the mandible with the clinical marginal bone level change (MBL) of the&#xD;
      NobelReplaceTM CC implants supporting NobelProceraTM Implant Bar Overdenture&#xD;
      (fixed-removable) in the maxilla for a period of 5 years.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        1. To evaluate and compare the cumulative survival rate (CSR) of the NobelReplaceTM CC&#xD;
           implants supporting NobelProceraTM Implant Bar Overdenture (fixed-removable) in the&#xD;
           mandible with the cumulative survival rate (CSR) of the NobelReplaceTM CC implants&#xD;
           supporting NobelProceraTM Implant Bar Overdenture (fixed-removable) in the maxilla for a&#xD;
           period of 5 years.&#xD;
&#xD;
        2. To evaluate and compare the cumulative survival rate (CSR) of NobelProceraTM Implant Bar&#xD;
           Overdenture (fixed-removable) on four (4) NobelReplace CC implants in the mandible with&#xD;
           the cumulative survival rate (CSR) of NobelProceraTM Implant Bar Overdenture&#xD;
           (fixed-removable) on four (4) NobelReplace CC implants in the maxilla after 5 years.&#xD;
&#xD;
        3. To evaluate the clinical behaviour (soft tissue behavior, clinical function, patient&#xD;
           satisfaction, Quality of Life and prosthetic maintenance needs such as wear, chipping of&#xD;
           denture teeth, need for exchange of attachment components) of NobelProceraTM Implant Bar&#xD;
           Overdenture (fixed-removable) in the mandible and maxilla over 5 years of clinical&#xD;
           function.&#xD;
&#xD;
      Study design 5-year, open, prospective, clinical multi-center study.&#xD;
&#xD;
      Number of subjects 76 (in total), 7-9 per center&#xD;
&#xD;
      Patient population Adult female or male, at least 18 (or age of consent) and not older than&#xD;
      70 years, suitable for treatment with implant supported bar overdentures in the edentulous&#xD;
      mandible or maxilla.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MBL,marginal bone level change</measure>
    <time_frame>6 month, 1, 2, 3, 5 year</time_frame>
    <description>To evaluate and compare the clinical marginal bone level change (change MBL)in relation to defined implant reference point and different time points in the maxilla and mandible(between baseline at implant insertion and follow-up time points at 1 month, 6 month, 1 year, 2 year, 3 year and 5 year after implant insertion) of observation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CSR implants</measure>
    <time_frame>6 month, 1, 2, 3, 5 year</time_frame>
    <description>CSR in % of placed implants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CSR prosthetics</measure>
    <time_frame>6 month, 1, 2, 3, 5 year</time_frame>
    <description>survival in % of placed final restorations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival Status</measure>
    <time_frame>6 month, 1, 2, 3, 5 year</time_frame>
    <description>Gingival status(Silness and Loe 1963):0 = Normal gingiva surrounding crown/control tooth,1 = Mild inflammation,2 = Moderate inflammation.3 = Severe inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Status of mucosa</measure>
    <time_frame>6 month, 1, 2, 3, 5 year,</time_frame>
    <description>0 = No keratinized mucosa.1 = Mucosa partially keratinized.2 = entire mucosa keratinized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding tendency</measure>
    <time_frame>6 month, 1, 2, 3, 5 year</time_frame>
    <description>(modified Sulcus Bleeding Index_mBI)(Mombelli):0 = No bleeding when a periodontal probe is passed along gingival margin adjacent to the implant.1 = Isolated bleeding spots visible. 2 = Blood forms a confluent red line on the margin 3 = Heavy or profuse bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plaque accumulation</measure>
    <time_frame>6 month, 1, 2, 3, 5 year</time_frame>
    <description>modified Plaque Index (mPlI) (Mombelli):0 = No detectible plaque. 1 = Plaque only recognized by running a probe across the marginal surface of the implant. 2 = Plaque can be seen by the naked eye.3 = Abundance of soft matter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pocket depths</measure>
    <time_frame>6 month, 1, 2, 3, 5 year</time_frame>
    <description>Pocket depths measured around implants in millimeter (mm)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Edentulous</condition>
  <arm_group>
    <arm_group_label>Mandible</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NobelReplace CC NobelProcera Implant Bar Titanium Overdenture (lab-made)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maxilla</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NobelReplace CC NobelProcera Implant Bar Titanium Overdenture (lab-made)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NobelReplace CC, NobelProcera Implant Bar</intervention_name>
    <description>Implants titanium with conical connection, individualized titanium bar</description>
    <arm_group_label>Mandible</arm_group_label>
    <arm_group_label>Maxilla</arm_group_label>
    <other_name>NobelReplace CC implants</other_name>
    <other_name>NobelProcera Implant Bar Titanium</other_name>
    <other_name>Overdenture (lab-made)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is at least 18 years of age (or age of consent) and has passed secession&#xD;
             of growth&#xD;
&#xD;
          2. The subject is not older than 70 years&#xD;
&#xD;
          3. Obtained informed consent from the subject&#xD;
&#xD;
          4. Edentulous mandible or maxilla providing sufficient bone whereas removable&#xD;
             NobelProceraTM Implant Bar Overdenture on four (4) implants is regarded as an&#xD;
             appropriate treatment solution&#xD;
&#xD;
          5. The subject has an osseous architecture enough to receive four implants and a&#xD;
             sufficient amount of bone for placing in healed or extraction sites implants with a&#xD;
             length of at least 10mm&#xD;
&#xD;
          6. The implant site is free from infection and extraction remnants&#xD;
&#xD;
          7. Implants will be placed in healed or extractions sites, defined as a site with 8 weeks&#xD;
             of healing following tooth extraction, respectively 6 months after major bone&#xD;
             augmentation or soft tissue grafting&#xD;
&#xD;
          8. Good gingival / periodontal / periapical status of opposing teeth/implants&#xD;
&#xD;
          9. The subject fulfills the prerequisite that a harmonic, stable occlusal relationship&#xD;
             can be achieved with opposing natural teeth resp. fixed or removable opposing&#xD;
             dentition (tooth or implant based&#xD;
&#xD;
         10. The subjects as well as the implant site(s) fulfill the criteria for early loading (6&#xD;
             weeks until 3 months after implant placement)&#xD;
&#xD;
         11. The subject is in such a physical and mental condition that a 5-year follow-up period&#xD;
             can be carried out without foreseeable problems&#xD;
&#xD;
         12. The subject is available for the 5-year term of the investigation&#xD;
&#xD;
         13. The subject is compliant with good oral hygiene&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject is not able to give her/his informed consent of participating&#xD;
&#xD;
          2. Health conditions, which do not permit the surgical (including anesthesia) or&#xD;
             restorative procedure&#xD;
&#xD;
          3. Reason to believe that the treatment might have a negative effect on the subject's&#xD;
             overall situation (psychiatric problems), as noted in subject records or in subject&#xD;
             history&#xD;
&#xD;
          4. Any disorders in the planned implant area such as previous tumors, chronic bone&#xD;
             disease or previous irradiation in the head/neck area&#xD;
&#xD;
          5. Alcohol or drug abuse as noted in subject records or in subject history&#xD;
&#xD;
          6. Smoking of &gt;10 cigarettes/day&#xD;
&#xD;
          7. 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;
          8. Pathologic occlusion, e.g. severe bruxism or other destructive habits&#xD;
&#xD;
          9. Lack of opposing dentition or unstable occlusion&#xD;
&#xD;
         10. Ongoing infections, endodontic or periodontal problems in opposing teeth or implants&#xD;
&#xD;
         11. Subject shows an unacceptable oral hygiene&#xD;
&#xD;
         12. Subject has allergic or adverse reactions to the restorative material.&#xD;
&#xD;
         13. Bone augmentation of more than 3mm vertical height performed less than 3 months prior&#xD;
             to planned implant placement.&#xD;
&#xD;
         14. Long-term bis-phosphonate therapy&#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>Guido Heydecke, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Poliklinik für Zahnärztliche Prothetik, University Hamburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alessandro Pozzi, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rome, Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eugenio Romeo, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Milan, Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marco Ferrari, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Siena, Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edoardo Stellini, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Padova, Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nikolaus and Alexandra Behneke, Prof., Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Mainz, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Silvio Meloni, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università degli Studi di Sassari</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guido Heydecke</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nikolaus and Alexandra Behneke</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eugenio Romeo</name>
      <address>
        <city>Milan</city>
        <zip>20143</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edoardo Stellini</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alessandro Pozzi</name>
      <address>
        <city>Rome</city>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università degli Studi di Sassari</name>
      <address>
        <city>Sassari</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marco Ferrari</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Italy</country>
  </location_countries>
  <removed_countries>
    <country>Switzerland</country>
    <country>United States</country>
  </removed_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>July 13, 2018</last_update_submitted>
  <last_update_submitted_qc>July 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>edentulous</keyword>
  <keyword>maxilla</keyword>
  <keyword>mandible</keyword>
  <keyword>dental implant</keyword>
  <keyword>bar</keyword>
  <keyword>overdenture</keyword>
  <keyword>Oral Health Impact Profile (OHIP)</keyword>
  <keyword>survival rate</keyword>
  <keyword>technical complications</keyword>
  <keyword>marginal bone level</keyword>
  <keyword>soft tissue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth, Edentulous</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>April 22, 2020</submitted>
    <returned>May 14, 2020</returned>
    <submitted>January 28, 2021</submitted>
    <submission_canceled>January 28, 2021</submission_canceled>
    <submitted>October 18, 2022</submitted>
    <returned>September 1, 2023</returned>
  </pending_results>
  <!-- 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/NCT01720420
org study id: T-174
nct id: NCT01720420
lead sponsor: 
collaborator: 
has dmc: Yes
AN OPEN 5-YEAR PROSPECTIVE, CLINICAL MULTI-CENTER STUDY on NobelProcera Implant Bar Titanium
      with Locator attachment and related Overdenture on 4 NobelReplace implants with conical
      connection (CC) in the mandible/maxilla.
Study centers: 8 centers in 4 countries

      Objectives of the study:

      Primary Objective:

      To evaluate and compare the clinical marginal bone level change (MBL) around the
      NobelReplaceTM CC implants supporting NobelProceraTM Implant Bar Overdenture
      (fixed-removable) in the mandible with the clinical marginal bone level change (MBL) of the
      NobelReplaceTM CC implants supporting NobelProceraTM Implant Bar Overdenture
      (fixed-removable) in the maxilla for a period of 5 years.

      Secondary Objectives:

        1. To evaluate and compare the cumulative survival rate (CSR) of the NobelReplaceTM CC
           implants supporting NobelProceraTM Implant Bar Overdenture (fixed-removable) in the
           mandible with the cumulative survival rate (CSR) of the NobelReplaceTM CC implants
           supporting NobelProceraTM Implant Bar Overdenture (fixed-removable) in the maxilla for a
           period of 5 years.

        2. To evaluate and compare the cumulative survival rate (CSR) of NobelProceraTM Implant Bar
           Overdenture (fixed-removable) on four (4) NobelReplace CC implants in the mandible with
           the cumulative survival rate (CSR) of NobelProceraTM Implant Bar Overdenture
           (fixed-removable) on four (4) NobelReplace CC implants in the maxilla after 5 years.

        3. To evaluate the clinical behaviour (soft tissue behavior, clinical function, patient
           satisfaction, Quality of Life and prosthetic maintenance needs such as wear, chipping of
           denture teeth, need for exchange of attachment components) of NobelProceraTM Implant Bar
           Overdenture (fixed-removable) in the mandible and maxilla over 5 years of clinical
           function.

      Study design 5-year, open, prospective, clinical multi-center study.

      Number of subjects 76 (in total), 7-9 per center

      Patient population Adult female or male, at least 18 (or age of consent) and not older than
      70 years, suitable for treatment with implant supported bar overdentures in the edentulous
      mandible or maxilla.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MBL,marginal bone level change
time frame: 6 month, 1, 2, 3, 5 year
description: To evaluate and compare the clinical marginal bone level change (change MBL)in relation to defined implant reference point and different time points in the maxilla and mandible(between baseline at implant insertion and follow-up time points at 1 month, 6 month, 1 year, 2 year, 3 year and 5 year after implant insertion) of observation.
measure: CSR implants
time frame: 6 month, 1, 2, 3, 5 year
description: CSR in % of placed implants
measure: CSR prosthetics
time frame: 6 month, 1, 2, 3, 5 year
description: survival in % of placed final restorations
measure: Gingival Status
time frame: 6 month, 1, 2, 3, 5 year
description: Gingival status(Silness and Loe 1963):0 = Normal gingiva surrounding crown/control tooth,1 = Mild inflammation,2 = Moderate inflammation.3 = Severe inflammation.
measure: Status of mucosa
time frame: 6 month, 1, 2, 3, 5 year,
description: 0 = No keratinized mucosa.1 = Mucosa partially keratinized.2 = entire mucosa keratinized.
measure: Bleeding tendency
time frame: 6 month, 1, 2, 3, 5 year
description: (modified Sulcus Bleeding Index_mBI)(Mombelli):0 = No bleeding when a periodontal probe is passed along gingival margin adjacent to the implant.1 = Isolated bleeding spots visible. 2 = Blood forms a confluent red line on the margin 3 = Heavy or profuse bleeding.
measure: plaque accumulation
time frame: 6 month, 1, 2, 3, 5 year
description: modified Plaque Index (mPlI) (Mombelli):0 = No detectible plaque. 1 = Plaque only recognized by running a probe across the marginal surface of the implant. 2 = Plaque can be seen by the naked eye.3 = Abundance of soft matter
measure: Pocket depths
time frame: 6 month, 1, 2, 3, 5 year
description: Pocket depths measured around implants in millimeter (mm)
arm group label: Mandible
arm group type: Experimental
description: NobelReplace CC NobelProcera Implant Bar Titanium Overdenture (lab-made)
arm group label: Maxilla
arm group type: Experimental
description: NobelReplace CC NobelProcera Implant Bar Titanium Overdenture (lab-made)
intervention type: Device
intervention name: NobelReplace CC, NobelProcera Implant Bar
description: Implants titanium with conical connection, individualized titanium bar
arm group label: Mandible
arm group label: Maxilla
other name: NobelReplace CC implants
other name: NobelProcera Implant Bar Titanium
other name: Overdenture (lab-made)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Guido Heydecke, Prof
role: Principal Investigator
affiliation: Poliklinik für Zahnärztliche Prothetik, University Hamburg
last name: Alessandro Pozzi, Prof
role: Principal Investigator
affiliation: University of Rome, Italy
last name: Eugenio Romeo, Prof
role: Principal Investigator
affiliation: University of Milan, Italy
last name: Marco Ferrari, Prof
role: Principal Investigator
affiliation: University of Siena, Italy
last name: Edoardo Stellini, Prof
role: Principal Investigator
affiliation: University of Padova, Italy
last name: Nikolaus and Alexandra Behneke, Prof., Dr.
role: Principal Investigator
affiliation: University of Mainz, Germany
last name: Silvio Meloni, Dr.
role: Principal Investigator
affiliation: Università degli Studi di Sassari
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Italy
country: Switzerland
country: United States
responsible party type: Sponsor
mesh term: Mouth, Edentulous
submitted: April 22, 2020
returned: May 14, 2020
submitted: January 28, 2021
submission canceled: January 28, 2021
submitted: October 18, 2022
returned: September 1, 2023