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Association of Force Distribution and Bone Resorption

Primary Purpose

Bone Resorption

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Panoramic Radiograph
T-Scan III occlusal system
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bone Resorption

Eligibility Criteria

49 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients wearing mandibular IODs opposing conventional maxillary CDs.
  • Patients wearing conventional maxillary and mandibular CDs.
  • Clearly visible anatomic landmarks of the panoramic radiography image.

Exclusion Criteria:

  • Patients with a history of temporomandibular joint dysfunction.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    CD group

    IOD group

    Arm Description

    Panoramic Radiographs and T-Scan III occlusal system

    Panoramic Radiographs and T-Scan III occlusal system

    Outcomes

    Primary Outcome Measures

    Residual ridge resorption
    To estimate residual ridge resorption in patients wearing implant overdentures and complete dentures using area index radiography method.

    Secondary Outcome Measures

    Occlusal force distribution
    To measure the percentage of occlusal force distribution in patients wearing implant overdentures and complete dentures using T-scan III occlusal analysis device.

    Full Information

    First Posted
    January 9, 2017
    Last Updated
    January 19, 2017
    Sponsor
    University of Malaya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03026894
    Brief Title
    Association of Force Distribution and Bone Resorption
    Official Title
    Association of Occlusal Force Distribution and Bone Resorption in Implant Supported Overdentures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Malaya

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Resorption

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CD group
    Arm Type
    Active Comparator
    Arm Description
    Panoramic Radiographs and T-Scan III occlusal system
    Arm Title
    IOD group
    Arm Type
    Active Comparator
    Arm Description
    Panoramic Radiographs and T-Scan III occlusal system
    Intervention Type
    Radiation
    Intervention Name(s)
    Panoramic Radiograph
    Intervention Description
    Measurement of bone resorption
    Intervention Type
    Device
    Intervention Name(s)
    T-Scan III occlusal system
    Intervention Description
    Recording percentage of force in maximum intercuspation
    Primary Outcome Measure Information:
    Title
    Residual ridge resorption
    Description
    To estimate residual ridge resorption in patients wearing implant overdentures and complete dentures using area index radiography method.
    Time Frame
    7 years
    Secondary Outcome Measure Information:
    Title
    Occlusal force distribution
    Description
    To measure the percentage of occlusal force distribution in patients wearing implant overdentures and complete dentures using T-scan III occlusal analysis device.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    49 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients wearing mandibular IODs opposing conventional maxillary CDs. Patients wearing conventional maxillary and mandibular CDs. Clearly visible anatomic landmarks of the panoramic radiography image. Exclusion Criteria: Patients with a history of temporomandibular joint dysfunction.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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