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
About this trial
This is an interventional diagnostic trial for Mandibular Deviation focused on measuring Mandibular deviation, mandibular movement recording
Eligibility Criteria
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
NCT ID
NCT03571035
First Posted
June 17, 2018
Last Updated
April 1, 2023
Sponsor
Poznan University of Medical Sciences
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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