<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/NCT03272828</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00003063</org_study_id>
    <nct_id>NCT03272828</nct_id>
  </id_info>
  <brief_title>Implant Overdenture Study</brief_title>
  <official_title>A Prospective Randomized Study on the Immediate Loading of Mandibular Overdentures Supported by Parallel Sided or Tapered Dental Titanium Implants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to compare two different types of dental implants which will be&#xD;
      used to support/retain a removable denture in the edentulous mandible. Subjects will have one&#xD;
      implant placed in the midline of the mandible after which the patient's existing denture will&#xD;
      be modified to fit the implant. The population of this study consists of healthy edentulous&#xD;
      individuals 20-75 years of age who have complete dentures in the upper and lower arch.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Titanium dental implants have been frequently used in the rehabilitation of edentulous&#xD;
      patients. Implants may provide adequate denture stability, improve oral function and oral&#xD;
      health related quality of life. There is evidence that implants supporting fixed and&#xD;
      removable prostheses have excellent long term success rates. Factors such as implant surface&#xD;
      characteristics, length, diameter and shape (parallel sided or tapered) may play and&#xD;
      important role for the outcome of the treatment especially when the immediate loading&#xD;
      protocol (loading of the implant the same day it is surgically placed) is utilized. There are&#xD;
      reports indicating that dental implants placed according to the immediate loading protocol&#xD;
      can be used to support removable prostheses in the mandible. Such protocol would minimize the&#xD;
      number of surgical procedures and significantly shorten the overall treatment time. Further,&#xD;
      increased oral health related quality of life has been reported from studies on mandibular&#xD;
      implant overdentures. Traditionally two implants have been suggested for the support of a&#xD;
      mandibular overdenture. However, high patient satisfaction rates and appropriate denture&#xD;
      retention have been reported among patients with a single implant placed in the mid-line. It&#xD;
      is also important to further evaluate and compare various implant designs to determine&#xD;
      clinical outcomes. The two dominating types of implant body design on the market are the&#xD;
      parallel-sided (straight) and the tapered (conical) shaped. Both implants have similar&#xD;
      threads, and the surgical procedure for placing the implants in the bone tissue is similar,&#xD;
      but the drills used have a slightly different design and shape. There are today no randomized&#xD;
      controlled studies evaluating differences in outcomes with respect to the external implant&#xD;
      design i.e. parallel sided or tapered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 15, 2012</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2022</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>Differences in success rate between the two types of dental implants studied</measure>
    <time_frame>1-5 years</time_frame>
    <description>Evaluating successful healing and long term outcomes</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Dental Implants</condition>
  <arm_group>
    <arm_group_label>Parallel sided implant Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A Parallel sided titanium dental implant will be placed in the edentulous mandible.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tapered shaped implant Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A tapered shaped titanium dental implant will be placed in the edentulous mandible.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nobel Biocare titanium dental implants</intervention_name>
    <arm_group_label>Parallel sided implant Group</arm_group_label>
    <arm_group_label>Tapered shaped implant Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be between 20 and 75 years of age&#xD;
&#xD;
          -  Be edentulous and have both upper and lower complete dentures&#xD;
&#xD;
          -  Present with ASA I or ASA II and no medical contraindications to implant treatment&#xD;
&#xD;
          -  Have adequate bone volume for placement of one (1) 4.0 mm diameter titanium dental&#xD;
             implant with a minimum length of 10 mm in the symphyseal area (=midline) of the&#xD;
             anterior mandible&#xD;
&#xD;
          -  Show absence of pathology such as cysts, infections in the gum tissue or bone and&#xD;
             remaining roots.&#xD;
&#xD;
          -  Be able to understand the procedures and have a jaw opening range of 30 mm or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ongoing chemotherapy&#xD;
&#xD;
          -  Previous radiation to head/neck&#xD;
&#xD;
          -  Ongoing corticosteroid medication&#xD;
&#xD;
          -  Ongoing blood thinner medication&#xD;
&#xD;
          -  Ongoing medication with psychopharmacological drugs&#xD;
&#xD;
          -  History of alcohol/drug abuse&#xD;
&#xD;
          -  Remaining teeth/root tips&#xD;
&#xD;
          -  Poor quality /fractured/severely worn dentures that cannot be modified to fit the&#xD;
             implant&#xD;
&#xD;
          -  Jaw opening range less than 30 mm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mats Kronstrom, DDS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the Regional Research Clinic, School of Dentistry at the University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kronstrom M, Davis B, Loney R, Gerrow J, Hollender L. Satisfaction and Clinical Outcomes Among Patients with Immediately Loaded Mandibular Overdentures Supported by One or Two Dental Implants: Results of a 5-Year Prospective Randomized Clinical Trial. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):128-136. doi: 10.11607/jomi.4824.</citation>
    <PMID>28095527</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>December 6, 2021</last_update_submitted>
  <last_update_submitted_qc>December 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Mats Kronstrom</investigator_full_name>
    <investigator_title>Professor, Department of Restorative Dentistry</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be shared with other researchers</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/NCT03272828
org study id: STUDY00003063
nct id: NCT03272828
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of the study is to compare two different types of dental implants which will be
      used to support/retain a removable denture in the edentulous mandible. Subjects will have one
      implant placed in the midline of the mandible after which the patient's existing denture will
      be modified to fit the implant. The population of this study consists of healthy edentulous
      individuals 20-75 years of age who have complete dentures in the upper and lower arch.
Titanium dental implants have been frequently used in the rehabilitation of edentulous
      patients. Implants may provide adequate denture stability, improve oral function and oral
      health related quality of life. There is evidence that implants supporting fixed and
      removable prostheses have excellent long term success rates. Factors such as implant surface
      characteristics, length, diameter and shape (parallel sided or tapered) may play and
      important role for the outcome of the treatment especially when the immediate loading
      protocol (loading of the implant the same day it is surgically placed) is utilized. There are
      reports indicating that dental implants placed according to the immediate loading protocol
      can be used to support removable prostheses in the mandible. Such protocol would minimize the
      number of surgical procedures and significantly shorten the overall treatment time. Further,
      increased oral health related quality of life has been reported from studies on mandibular
      implant overdentures. Traditionally two implants have been suggested for the support of a
      mandibular overdenture. However, high patient satisfaction rates and appropriate denture
      retention have been reported among patients with a single implant placed in the mid-line. It
      is also important to further evaluate and compare various implant designs to determine
      clinical outcomes. The two dominating types of implant body design on the market are the
      parallel-sided (straight) and the tapered (conical) shaped. Both implants have similar
      threads, and the surgical procedure for placing the implants in the bone tissue is similar,
      but the drills used have a slightly different design and shape. There are today no randomized
      controlled studies evaluating differences in outcomes with respect to the external implant
      design i.e. parallel sided or tapered.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Differences in success rate between the two types of dental implants studied
time frame: 1-5 years
description: Evaluating successful healing and long term outcomes
arm group label: Parallel sided implant Group
arm group type: Active Comparator
description: A Parallel sided titanium dental implant will be placed in the edentulous mandible.
arm group label: Tapered shaped implant Group
arm group type: Active Comparator
description: A tapered shaped titanium dental implant will be placed in the edentulous mandible.
intervention type: Device
intervention name: Nobel Biocare titanium dental implants
arm group label: Parallel sided implant Group
arm group label: Tapered shaped implant Group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mats Kronstrom, DDS, PhD
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
citation: Kronstrom M, Davis B, Loney R, Gerrow J, Hollender L. Satisfaction and Clinical Outcomes Among Patients with Immediately Loaded Mandibular Overdentures Supported by One or Two Dental Implants: Results of a 5-Year Prospective Randomized Clinical Trial. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):128-136. doi: 10.11607/jomi.4824.
PMID: 28095527
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Mats Kronstrom
investigator title: Professor, Department of Restorative Dentistry
sharing ipd: No
ipd description: IPD will not be shared with other researchers