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The Vision System for Mandibular Trajectory Assessment in Women With Mild Temporomandibular Joint Disorder (UMP14/06)

Primary Purpose

Mandibular Deviation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mandibular movements recordings by a mono vision system
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mandibular Deviation focused on measuring Mandibular deviation, mandibular movement recording

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • temporomandibular joint disorder
  • qualitative and quantitative impairments of mandibular movements

Exclusion Criteria:

  • no impairments of mandibular movements

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Example

    Arm Description

    Mandibular movements recordings by a mono vision system.

    Outcomes

    Primary Outcome Measures

    Range of mandibular abduction [mm]
    The maximum mouth opening value calculated as the difference in the distance between the markers before registration and during the maximum opening.
    Maximum displacement in frontal plane [mm]
    The value of the maximum deviation of the lower marker in relation to the upper one in the frontal plane.
    Normalized displacement in frontal plane [mm^2/s]
    The value of normalized displacement calculated by dividing the sum of squared errors in movement trajectory on the transverse axis by the number of measurements taken during analysis time.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 17, 2018
    Last Updated
    April 1, 2023
    Sponsor
    Poznan University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03571035
    Brief Title
    The Vision System for Mandibular Trajectory Assessment in Women With Mild Temporomandibular Joint Disorder
    Acronym
    UMP14/06
    Official Title
    Presentation of Light and Affordable Vision System for Mandibular Trajectory Assessment in Women With Mild Temporomandibular Joint Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    July 15, 2017 (Actual)
    Study Completion Date
    December 10, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Poznan University of Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Recording mandibular movements plays an important role in stomatognathic system diagnosis and has been the subject of numerous research projects. This study presents theoretical assumptions and a practical solution in the form of a novel method of mandibular motion assessment.
    Detailed Description
    In the presented method, mandibular movements are recorded by a mono vision system where a digital camera is fixed on a special extension arm attached to patient's head. During movement the camera records changing positions of two markers placed on two selected two points on a patient's face. With such data, it possible to assess the absolute range of mandibular abduction as well as displacements from optimal trajectory occurring during movement, which indicative of stomatognathic dysfunctions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mandibular Deviation
    Keywords
    Mandibular deviation, mandibular movement recording

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Example
    Arm Type
    Experimental
    Arm Description
    Mandibular movements recordings by a mono vision system.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Mandibular movements recordings by a mono vision system
    Intervention Description
    To examine the mandible's movements, vision analysis was employed and performed with the digital camera which featured 1920 x 1080 resolution and was fixed on an aluminium extension arm attached to a headset worn by the subject.The camera was aligned parallel to the subject's face at a distance of 0.3 meters. The study used two 10 mm x 5 mm reference markers, which were accurately reproduced on the camera recorded images. In line, one marker was put on the medial cleft above the upper lip, and the other one was positioned below the first one in a straight line, in the middle of the chin. Then, the patient was asked to open maximally and close the mouth twice.To establish the mandible's trajectory, the line was drawn between the positions of the two markers to connect the two points. The line's parameters were calculated only during initial measurements and were constant throughout the study.
    Primary Outcome Measure Information:
    Title
    Range of mandibular abduction [mm]
    Description
    The maximum mouth opening value calculated as the difference in the distance between the markers before registration and during the maximum opening.
    Time Frame
    about 2 minutes
    Title
    Maximum displacement in frontal plane [mm]
    Description
    The value of the maximum deviation of the lower marker in relation to the upper one in the frontal plane.
    Time Frame
    about 2 minutes
    Title
    Normalized displacement in frontal plane [mm^2/s]
    Description
    The value of normalized displacement calculated by dividing the sum of squared errors in movement trajectory on the transverse axis by the number of measurements taken during analysis time.
    Time Frame
    about 2 minutes

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: temporomandibular joint disorder qualitative and quantitative impairments of mandibular movements Exclusion Criteria: no impairments of mandibular movements
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Przemysław Lisiński, PhD
    Organizational Affiliation
    Poznań University of Medical Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    The Vision System for Mandibular Trajectory Assessment in Women With Mild Temporomandibular Joint Disorder

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