<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/NCT03026894</url>
  </required_header>
  <id_info>
    <org_study_id>PG012-2014A</org_study_id>
    <nct_id>NCT03026894</nct_id>
  </id_info>
  <brief_title>Association of Force Distribution and Bone Resorption</brief_title>
  <official_title>Association of Occlusal Force Distribution and Bone Resorption in Implant Supported Overdentures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the residual ridge resorption at anterior and posterior maxillary and&#xD;
      posterior mandibular ridges among conventional complete dentures and implant overdenture&#xD;
      wearers, and determine its association with the relative occlusal forces distribution,&#xD;
      treatment groups and other patient variables.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of forty-six edentulous patients participated in this clinical study divided into two&#xD;
      groups as following; complete denture group (CD) consists of 23 patients wearing conventional&#xD;
      complete dentures and another Implant overdenture group (IOD) consists of 23 patients wearing&#xD;
      mandibular complete overdenture with 2 implants. Two panoramic radiographs at baseline and in&#xD;
      a follow-up to 7 years were used to measure the ratio of bone changes between the anatomical&#xD;
      bone area and the reference area in the maxillary and the mandibular ridges. The occlusal&#xD;
      contacts percentage of force in maximum intercuspation anteriorly and posteriorly were&#xD;
      recorded for both groups by using T-Scan III system.&#xD;
&#xD;
      Oral and written information in English or Malay language, regarding the study, was provided&#xD;
      and written consent obtained before enrolment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Residual ridge resorption</measure>
    <time_frame>7 years</time_frame>
    <description>To estimate residual ridge resorption in patients wearing implant overdentures and complete dentures using area index radiography method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occlusal force distribution</measure>
    <time_frame>1 year</time_frame>
    <description>To measure the percentage of occlusal force distribution in patients wearing implant overdentures and complete dentures using T-scan III occlusal analysis device.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Bone Resorption</condition>
  <arm_group>
    <arm_group_label>CD group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Panoramic Radiographs and T-Scan III occlusal system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IOD group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Panoramic Radiographs and T-Scan III occlusal system</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Panoramic Radiograph</intervention_name>
    <description>Measurement of bone resorption</description>
    <arm_group_label>CD group</arm_group_label>
    <arm_group_label>IOD group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>T-Scan III occlusal system</intervention_name>
    <description>Recording percentage of force in maximum intercuspation</description>
    <arm_group_label>CD group</arm_group_label>
    <arm_group_label>IOD group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients wearing mandibular IODs opposing conventional maxillary CDs.&#xD;
&#xD;
          -  Patients wearing conventional maxillary and mandibular CDs.&#xD;
&#xD;
          -  Clearly visible anatomic landmarks of the panoramic radiography image.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of temporomandibular joint dysfunction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>49 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</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>Bone Resorption</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salicylic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03026894
org study id: PG012-2014A
nct id: NCT03026894
lead sponsor: 
has dmc: Yes
To investigate the residual ridge resorption at anterior and posterior maxillary and
      posterior mandibular ridges among conventional complete dentures and implant overdenture
      wearers, and determine its association with the relative occlusal forces distribution,
      treatment groups and other patient variables.
A total of forty-six edentulous patients participated in this clinical study divided into two
      groups as following; complete denture group (CD) consists of 23 patients wearing conventional
      complete dentures and another Implant overdenture group (IOD) consists of 23 patients wearing
      mandibular complete overdenture with 2 implants. Two panoramic radiographs at baseline and in
      a follow-up to 7 years were used to measure the ratio of bone changes between the anatomical
      bone area and the reference area in the maxillary and the mandibular ridges. The occlusal
      contacts percentage of force in maximum intercuspation anteriorly and posteriorly were
      recorded for both groups by using T-Scan III system.

      Oral and written information in English or Malay language, regarding the study, was provided
      and written consent obtained before enrolment.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Residual ridge resorption
time frame: 7 years
description: To estimate residual ridge resorption in patients wearing implant overdentures and complete dentures using area index radiography method.
measure: Occlusal force distribution
time frame: 1 year
description: To measure the percentage of occlusal force distribution in patients wearing implant overdentures and complete dentures using T-scan III occlusal analysis device.
arm group label: CD group
arm group type: Active Comparator
description: Panoramic Radiographs and T-Scan III occlusal system
arm group label: IOD group
arm group type: Active Comparator
description: Panoramic Radiographs and T-Scan III occlusal system
intervention type: Radiation
intervention name: Panoramic Radiograph
description: Measurement of bone resorption
arm group label: CD group
arm group label: IOD group
intervention type: Device
intervention name: T-Scan III occlusal system
description: Recording percentage of force in maximum intercuspation
arm group label: CD group
arm group label: IOD group
criteria: 
gender: All
minimum age: 49 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Bone Resorption
mesh term: Salicylic Acid
sharing ipd: No