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

Mandibular Deviation Clinical Trial

— UMP14/06  

Official title:

Presentation of Light and Affordable Vision System for Mandibular Trajectory Assessment in Women With Mild Temporomandibular Joint Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03571035
• Other study ID #: 501/14
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 10, 2017

Study information

• Verified date: April 2023
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 10, 2017
• Est. primary completion date: July 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• temporomandibular joint disorder

• qualitative and quantitative impairments of mandibular movements

Exclusion Criteria:

• no impairments of mandibular movements

Related Conditions & MeSH terms

• Joint Diseases
• Mandibular Deviation
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	about 2 minutes
Primary	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.	about 2 minutes
Primary	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.	about 2 minutes