<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/NCT03837158</url>
  </required_header>
  <id_info>
    <org_study_id>Mini 1286_2018</org_study_id>
    <nct_id>NCT03837158</nct_id>
  </id_info>
  <brief_title>Titanium Zirconium (TiZr) Mini Implants</brief_title>
  <official_title>Is the Stabilization of a Mandibular Overdenture Employing Four Novel One-piece Immediately Loaded TiZr Implants With Miniaturized Stud-type Attachments a Feasible Alternative to Two Two-piece Early Loaded Tissue-level Implants With Regular Stud-type Attachments?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bern</source>
  <oversight_info>
    <has_dmc>No</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>
      H0: &quot;Within the first year post-placement, four interforaminally placed, immediately loaded&#xD;
      2.4 mm narrow-diameter one-piece TiZr implants with miniaturized stud-type attachments show&#xD;
      improved patient-reported outcome measures (PROMS) compared to two interforaminally placed,&#xD;
      early loaded, TiZr two-piece implants with stud-type attachments to retain a mandibular&#xD;
      overdenture.&quot;The specific aim is to compare both treatment alternatives to evaluate which one&#xD;
      may be recommended for elderly edentulous patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Anticipated">May 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Geriatric Oral Health Assessment Index (GOHAI)</measure>
    <time_frame>One-year follow-up</time_frame>
    <description>Change from baseline questionnaires in Oral Health Related Quality of Life (OHRQoL).&#xD;
Scores 0-60: higher values represent lower OHRQoL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Additional Oral Health Impact Profile for edentulism (OHIP-EDENT)</measure>
    <time_frame>Follow-up (up to 365 days)</time_frame>
    <description>Change from baseline questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional PROM Denture Satisfaction Index (DSI)</measure>
    <time_frame>Baseline, follow-up (up to 365 days)</time_frame>
    <description>Change in Denture Satisfaction higher values represent better satisfaction (0-1200mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant Survival</measure>
    <time_frame>at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up</time_frame>
    <description>Survival (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant Success</measure>
    <time_frame>at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up</time_frame>
    <description>Success according to Misch (2007) Misch criteria scores 1-4: higher values represent better success</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosthetic Survival</measure>
    <time_frame>Baseline, follow-up (up to 365 days)</time_frame>
    <description>Prosthetic Survival (yes/no): is the denture still in place?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chewing Efficiency</measure>
    <time_frame>Baseline, follow-up (up to 365 days)</time_frame>
    <description>Color mixing test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque Index</measure>
    <time_frame>at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up</time_frame>
    <description>Plaque Index Scores 0-3 3= thick plaque is visible along gingival margin 2= plaque is visible along gingival margin, with or without air drying&#xD;
1= following air drying, plaque is not visible but can be wiped off with an explorer 0= following air drying, plaque is not visible nor can be wiped off with an explorer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding Index</measure>
    <time_frame>at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up</time_frame>
    <description>Bleeding Index Scores 0-3 0= Healthy gingival&#xD;
Gingival look inflamed, but don't bleed when probed&#xD;
Gingival look inflamed and bleed when probed&#xD;
Ulceration and spontaneous bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pocket Probing depth</measure>
    <time_frame>at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up</time_frame>
    <description>depth measured in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-Cost-Analysis</measure>
    <time_frame>After surgery, after implants loading, after follow-up (up to 365 days)</time_frame>
    <description>Total treatment time will be collected and added. Total treatment cost will be evaluated and a ratio will be calculated. The groups will be compared on the base of this ration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost Effectiveness and Willingness to Pay</measure>
    <time_frame>Total change and time at 1y follow-up</time_frame>
    <description>Cost effectiveness wil be calculated as a ratio of treatment cost in relation to change of GOHAI sum score. This will allow to evaluate how much monetary item is needed to achieve a change in GOHAI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-vivo evaluated loss of retentive force</measure>
    <time_frame>after implant loading (expected to be after 6 weeks on average) and at follow-up (up to 365 days)</time_frame>
    <description>Measurement with a hand-held digital force gauge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Dental Implants</condition>
  <arm_group>
    <arm_group_label>Control-group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two Tissue Level TiZr Sand blasted long grit acid-etched (SLA) implants placed in positions 33 and 43 (diameter 3.3mm, length ≥10mm), early loading</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental-group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four narrow-diameter implants (NDI) TiZr SLA implants in positions 34, 32, 42, and 44 (diameter 2.4mm, length ≥10mm), immediate loading</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>early loading</intervention_name>
    <description>two TiZr implants on SLA surface</description>
    <arm_group_label>Control-group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>immediate loading</intervention_name>
    <description>four TiZr implants on SLA surface</description>
    <arm_group_label>Experimental-group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At patient level:&#xD;
&#xD;
               -  Written informed consent&#xD;
&#xD;
               -  Age ≥ 18 years&#xD;
&#xD;
               -  Sufficient complete dentures (Marxkors and Ferger, 1989) not older than 1 year&#xD;
&#xD;
               -  Patient is unsatisfied with mandibular denture to the degree that he/she seeks&#xD;
                  treatment&#xD;
&#xD;
          -  At site level:&#xD;
&#xD;
               -  Healed edentulous mandible (minimum 8 weeks since last extraction)&#xD;
&#xD;
               -  Minimal ridge dimensions 5.5 mm (width) by 12 mm (height) in the anterior&#xD;
                  (interforaminal) area, allowing the placement of 3.3 (endosseous diameter) by 10&#xD;
                  mm (length) implants&#xD;
&#xD;
               -  Opposing dentition: complete denture on a edentulous maxilla&#xD;
&#xD;
               -  Physical status (PS) 1 and 2 (American Society of Anesthesiologists)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  At patient level&#xD;
&#xD;
               -  Any physical or mental disorder that would interfere with the ability to perform&#xD;
                  adequate oral hygiene or the capability of providing written informed consent and&#xD;
                  compliance to the protocol&#xD;
&#xD;
               -  Any disorder that would interfere with wound healing or represent a&#xD;
                  contraindication for oral surgery such as, but not limited to, uncontrolled&#xD;
                  diabetes or conditions resulting in or requiring immunosuppression, radiation,&#xD;
                  chemotherapy, frequent use of antibiotics or antiresorptive medication such as&#xD;
                  bisphosphonates&#xD;
&#xD;
               -  Pregnancy or lactation&#xD;
&#xD;
               -  Heavy smoking habit with &gt; 20 cig/d&#xD;
&#xD;
               -  Severe bruxism or clenching habits, present oro-facial pain&#xD;
&#xD;
          -  At site level:&#xD;
&#xD;
               -  Ridge defects requiring staged bone augmentation procedures (simultaneous Guided&#xD;
                  Bone Regeneration (GBR) within the ridge contour allowed)&#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>Beat Wallkamm, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Private Practice</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin Schimmel, Prof</last_name>
    <role>Study Director</role>
    <affiliation>University of Bern</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martin Schimmel, Prof.</last_name>
    <phone>0316322597</phone>
    <email>martin.schimmel@zmk.unibe.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Beatrice Gerber</last_name>
    <phone>0316328628</phone>
    <email>beatrice.gerber@zmk.unibe.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Private Practice Dr. B. Wallkamm</name>
      <address>
        <city>Langenthal</city>
        <state>Bern</state>
        <zip>4900</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Beat Wallkamm, Dr</last_name>
      <phone>062 919 40 10</phone>
      <email>wallkamm@bluewin.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martin Schimmel, Prof.</last_name>
      <phone>+41316322597</phone>
      <email>martin.schimmel@zmk.unibe.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>It is not planned to use the data of this study for future research.</ipd_description>
  </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/NCT03837158
org study id: Mini 1286_2018
nct id: NCT03837158
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
H0: "Within the first year post-placement, four interforaminally placed, immediately loaded
      2.4 mm narrow-diameter one-piece TiZr implants with miniaturized stud-type attachments show
      improved patient-reported outcome measures (PROMS) compared to two interforaminally placed,
      early loaded, TiZr two-piece implants with stud-type attachments to retain a mandibular
      overdenture."The specific aim is to compare both treatment alternatives to evaluate which one
      may be recommended for elderly edentulous patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Geriatric Oral Health Assessment Index (GOHAI)
time frame: One-year follow-up
description: Change from baseline questionnaires in Oral Health Related Quality of Life (OHRQoL).
Scores 0-60: higher values represent lower OHRQoL
measure: Additional Oral Health Impact Profile for edentulism (OHIP-EDENT)
time frame: Follow-up (up to 365 days)
description: Change from baseline questionnaires
measure: Additional PROM Denture Satisfaction Index (DSI)
time frame: Baseline, follow-up (up to 365 days)
description: Change in Denture Satisfaction higher values represent better satisfaction (0-1200mm)
measure: Implant Survival
time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
description: Survival (yes/no)
measure: Implant Success
time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
description: Success according to Misch (2007) Misch criteria scores 1-4: higher values represent better success
measure: Prosthetic Survival
time frame: Baseline, follow-up (up to 365 days)
description: Prosthetic Survival (yes/no): is the denture still in place?
measure: Chewing Efficiency
time frame: Baseline, follow-up (up to 365 days)
description: Color mixing test
measure: Plaque Index
time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
description: Plaque Index Scores 0-3 3= thick plaque is visible along gingival margin 2= plaque is visible along gingival margin, with or without air drying
1= following air drying, plaque is not visible but can be wiped off with an explorer 0= following air drying, plaque is not visible nor can be wiped off with an explorer
measure: Bleeding Index
time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
description: Bleeding Index Scores 0-3 0= Healthy gingival
Gingival look inflamed, but don't bleed when probed
Gingival look inflamed and bleed when probed
Ulceration and spontaneous bleeding
measure: Pocket Probing depth
time frame: at implant loading (at 24 hours for arm B, at 6-8 weeks for arm A), at the one-year follow-up
description: depth measured in mm
measure: Time-Cost-Analysis
time frame: After surgery, after implants loading, after follow-up (up to 365 days)
description: Total treatment time will be collected and added. Total treatment cost will be evaluated and a ratio will be calculated. The groups will be compared on the base of this ration
measure: Cost Effectiveness and Willingness to Pay
time frame: Total change and time at 1y follow-up
description: Cost effectiveness wil be calculated as a ratio of treatment cost in relation to change of GOHAI sum score. This will allow to evaluate how much monetary item is needed to achieve a change in GOHAI
measure: In-vivo evaluated loss of retentive force
time frame: after implant loading (expected to be after 6 weeks on average) and at follow-up (up to 365 days)
description: Measurement with a hand-held digital force gauge
arm group label: Control-group
arm group type: Experimental
description: Two Tissue Level TiZr Sand blasted long grit acid-etched (SLA) implants placed in positions 33 and 43 (diameter 3.3mm, length ≥10mm), early loading
arm group label: Experimental-group
arm group type: Experimental
description: Four narrow-diameter implants (NDI) TiZr SLA implants in positions 34, 32, 42, and 44 (diameter 2.4mm, length ≥10mm), immediate loading
intervention type: Procedure
intervention name: early loading
description: two TiZr implants on SLA surface
arm group label: Control-group
intervention type: Procedure
intervention name: immediate loading
description: four TiZr implants on SLA surface
arm group label: Experimental-group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Beat Wallkamm, Dr
role: Principal Investigator
affiliation: Private Practice
last name: Martin Schimmel, Prof
role: Study Director
affiliation: University of Bern
last name: Martin Schimmel, Prof.
phone: 0316322597
email: martin.schimmel@zmk.unibe.ch
last name: Beatrice Gerber
phone: 0316328628
email: beatrice.gerber@zmk.unibe.ch
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No
ipd description: It is not planned to use the data of this study for future research.