Diseases of the Temporomandibular JointCinématiqueATMNCT03305315
Study of Temporomandibular Joint Dysfunction
An observational study of Diseases of the Temporomandibular Joint, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Given the frequency of temporomandibular joint (TMJ) dysfunction and the variations in its expression, this project intends to initiate a process of objective evaluation of mandible function and its impairment due to different diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diseases of the Temporomandibular Joint
- What is being tested?
- Measurements of jaw movement and Measurement of natural electrical activity of facial muscles
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2017to 22 Nov 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with temporomandibular joint disorders and asymptomatic subjects
Who may be able to join
- Patients:
- Patients who have provided verbal consent,
- Patients over 18 years old,
- Patients with mandible dentition compatible with placement of the kinetic measurement device,
- Patients with a TMJ disease requiring surgery (irreducible dislocation of the joint disc, damage to the joint disc requiring discectomy, ankylosis or severe arthritis of the mandible requiring mandible implants or a TMJ prosthesis).
- Asymptomatic subjects:
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- Subjects who have provided verbal consent,
- Subjects over 18 years old,
- Subjects with Class 1 occlusion,
- Subjects without dental implants,
- Subjects with no history of joint dysfunction,
- Absence of clicking, popping, or grating sounds during large movements and during palpation of the TMJ with the mouth slightly open (distance between incisors around 1 cm)
- Absence of headache,
- Absence of tinnitus,
- Kinematic curves around the mean.
Who cannot join
- Adults under guardianship,
- Patients without national health insurance cover.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Movement of the Pathological Temporomandibular Joint.
Given the frequency of temporomandibular joint (TMJ) dysfunction and the variations in its expression, this project intends to initiate a process of objective evaluation of mandible function and its impairment due to different diseases. The first step is to determine whether 3D kinematic quantification of the mandible would make it possible to objectively assess the effect of post-operative management on TMJ function recovery. If the first results are encouraging and show the sensitivity of the analysis of minor joint dysfunctions, the investigators will evaluate the feasibility of kinematic assessments for major TMJ dysfunctions and for the follow-up of patients.
The expected benefits of this study are to be considered in the medium term and concern the possibilities offered by measuring mandible kinetics in the treatment of TMJ disorders.
- Conditions
- Diseases of the Temporomandibular Joint
- Being tested
- Measurements of jaw movement, Measurement of natural electrical activity of facial muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurements of jaw movementOther
Jaw mobility will be measured during simple movements of the mouth (opening the mouth, side-to-side and backwards-and-forwards movement of the jaw). These movements will be measured using a specific apparatus, part of which will be placed on the head like a helmet with the other part placed in the mouth and stuck to the teeth using a dental adhesive. The part in the mouth is specifically designed for this purpose. Measurements using this apparatus will take around 30 minutes.
Measurement of natural electrical activity of facial musclesOther
Natural electrical activity of the facial muscles will be measured using electrodes placed on the skin.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Diseases of the temporomandibular joint Receives: Other: Measurements of jaw movement; Other: Measurement of natural electrical activity of facial muscles | |
| Controls | Asymptomatic subjects Receives: Other: Measurement of natural electrical activity of facial muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility of the jaw with regard to the skull during each movement.
Measured: Until 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start12 Dec 2017
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diseases of the Temporomandibular JointStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305315
- Sponsor's protocol ID
- ZWETYENGA ENIM 2016
- Acronym
- CinématiqueATM
- Status last verified
- Jan 2021
- First submitted
- 4 Oct 2017
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Movement of the Pathological Temporomandibular Joint.
- ClinicalTrials.gov ID
- NCT03305315
- Acronym / sponsor ID
- CinématiqueATM / ZWETYENGA ENIM 2016
- Conditions
- Diseases of the Temporomandibular Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 9 Oct 2017 (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.
Given the frequency of temporomandibular joint (TMJ) dysfunction and the variations in its expression, this project intends to initiate a process of objective evaluation of mandible function and its impairment due to different diseases. The first step is to determine whether 3D kinematic quantification of the mandible would make it possible to objectively assess the effect of post-operative management on TMJ function recovery. If the first results are encouraging and show the sensitivity of the analysis of minor joint dysfunctions, the investigators will evaluate the feasibility of kinematic assessments for major TMJ dysfunctions and for the follow-up of patients.
The expected benefits of this study are to be considered in the medium term and concern the possibilities offered by measuring mandible kinetics in the treatment of TMJ disorders.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Measurements of jaw movement, Other: Measurement of natural electrical activity of facial musclesDiseases of the temporomandibular joint |
| Controls | – | Other: Measurement of natural electrical activity of facial musclesAsymptomatic subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with temporomandibular joint disorders and asymptomatic subjects
Key inclusion criteria (15 listed)
- Patients who have provided verbal consent,
- Patients over 18 years old,
- Patients with mandible dentition compatible with placement of the kinetic measurement device,
- Patients with a TMJ disease requiring surgery (irreducible dislocation of the joint disc, damage to the joint disc requiring discectomy, ankylosis or severe arthritis of the mandible requiring mandible implants or a TMJ prosthesis).
- Subjects who have provided verbal consent,
Key exclusion criteria (2 listed)
- Adults under guardianship,
- Patients without national health insurance cover.
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 |
|---|---|---|
| Measurements of jaw movementJaw mobility will be measured during simple movements of the mouth (opening the mouth, side-to-side and backwards-and-forwards movement of the jaw). These movements will be measured using a specific apparatus, part of which will be placed on the head like a helmet with the other part placed in the mouth and stuck to the teeth using a dental adhesive. The part in the mouth is specifically designed for this purpose. Measurements using this apparatus will take around 30 minutes. | Other | Cases |
| Measurement of natural electrical activity of facial musclesNatural electrical activity of the facial muscles will be measured using electrodes placed on the skin. | Other | Cases, Controls |
Primary outcome
Mobility of the jaw with regard to the skull during each movement.
Time frame: Until 6 months post-surgery
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 26 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diseases of the Temporomandibular Joint, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 15 inclusion and 2 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 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Mobility of the jaw with regard to the skull during each movement. (time frame: Until 6 months post-surgery). 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 26 Jan 2021.