Mandibular DeviationUMP14/06NCT03571035
The Vision System for Mandibular Trajectory Assessment in Women With Mild Temporomandibular Joint Disorder
A study testing Mandibular movements recordings by a mono vision system in people with Mandibular Deviation, run by Poznan University of Medical Sciences.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Mandibular Deviation
- What is being tested?
- Mandibular movements recordings by a mono vision system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 10 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- temporomandibular joint disorder
- qualitative and quantitative impairments of mandibular movements
Who cannot join
- no impairments of mandibular movements
About this study
Official title: 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.
Read the 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.
- Conditions
- Mandibular Deviation
- Being tested
- Mandibular movements recordings by a mono vision system
- Keywords
- Mandibular deviation, mandibular movement recording
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular movements recordings by a mono vision systemDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Example | Experimental | Mandibular movements recordings by a mono vision system. Receives: Diagnostic Test: Mandibular movements recordings by a mono vision system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: about 2 minutes
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.
Measured: about 2 minutes
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.
Measured: about 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start1 Jan 2015
- Primary completion15 Jul 2017
- Study completion10 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular DeviationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jagoda Goślińska, Poznan University of Medical Sciences
- Investigators
- Przemysław Lisiński, PhD, Study director, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571035
- Sponsor's protocol ID
- 501/14
- Acronym
- UMP14/06
- Status last verified
- Apr 2023
- First submitted
- 17 Jun 2018
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presentation of Light and Affordable Vision System for Mandibular Trajectory Assessment in Women With Mild Temporomandibular Joint Disorder
- ClinicalTrials.gov ID
- NCT03571035
- Acronym / sponsor ID
- UMP14/06 / 501/14
- Conditions
- Mandibular Deviation
- Keywords
- Mandibular deviation, mandibular movement recording
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 10 Dec 2017 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Example | Experimental | Diagnostic Test: Mandibular movements recordings by a mono vision systemMandibular movements recordings by a mono vision system. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- temporomandibular joint disorder
- qualitative and quantitative impairments of mandibular movements
Key exclusion criteria (1 listed)
- no impairments of mandibular movements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandibular movements recordings by a mono vision systemTo 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. | Diagnostic test | Example |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
Related trials for Mandibular Deviation
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
Recruiting
Calcium Gluconate Activated in Anterior Disc Displacement With Reduction of the Temporomandibular Joint
Temporomandibular Joint Disorders
Not yet recruiting
Effects of Orofacial Myofunctional Therapy and Cervical Stabilization Exercises in Patients With Axis-i Group Iia Temporomandibular Dysfunction
Temporo-mandibular Dysfunction, Disc Displacement
Not yet recruiting
Effects of Orofascial Myofunctional Therapy and Cervical Stabilization Exercises on Temporomandibular Dysfunction
Temporomandibular Disorders (TMDs), Temporo-mandibular Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Przemysław Lisiński, PhD study director
Poznań University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular movements recordings by a mono vision system in people with Mandibular Deviation, run by Poznan University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of mandibular abduction [mm] (time frame: about 2 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.