- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03571035
The Vision System for Mandibular Trajectory Assessment in Women With Mild Temporomandibular Joint Disorder (UMP14/06)
April 1, 2023 updated by: Jagoda Goślińska, Poznan University of Medical Sciences
Presentation of Light and Affordable Vision System for Mandibular Trajectory Assessment in Women With Mild Temporomandibular Joint Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- temporomandibular joint disorder
- qualitative and quantitative impairments of mandibular movements
Exclusion Criteria:
- no impairments of mandibular movements
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Example
Mandibular movements recordings by a mono vision system.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of mandibular abduction [mm]
Time Frame: about 2 minutes
|
The maximum mouth opening value calculated as the difference in the distance between the markers before registration and during the maximum opening.
|
about 2 minutes
|
|
Maximum displacement in frontal plane [mm]
Time Frame: about 2 minutes
|
The value of the maximum deviation of the lower marker in relation to the upper one in the frontal plane.
|
about 2 minutes
|
|
Normalized displacement in frontal plane [mm^2/s]
Time Frame: about 2 minutes
|
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.
|
about 2 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
July 15, 2017
Study Completion (Actual)
December 10, 2017
Study Registration Dates
First Submitted
June 17, 2018
First Submitted That Met QC Criteria
June 26, 2018
First Posted (Actual)
June 27, 2018
Study Record Updates
Last Update Posted (Actual)
April 4, 2023
Last Update Submitted That Met QC Criteria
April 1, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 501/14
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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