Temporomandibular DisorderDAMNCT03283839
Consequences of Temporomandibular Disorder on Balance Control
A study testing Posturography in people with Temporomandibular Disorder and Pathophysiology, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
To evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder, Pathophysiology, Therapy
- What is being tested?
- Posturography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2017to 25 Jun 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient group: TMD patients, care: occlusal splint therapy, behavioral advices
- Control group: matched with TMD patients (age, sex, lifestyle).
Who cannot join
- Patient group: treatment generating secondary effects in postural control (psychotrop, antidepressor, antihypertensive drugs); osteoarticular pathologies and recent trauma (< 4 months); vertigo and dysequilibrium (< 6 months), whiplash
- Control group: id. and TMD.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle.
Parameters will be estimated by measures realized before the therapeutic care of the TMD (T0), then 2, 3 and 5 months after the starting care, both in TMD patients and control subjects. To evaluate also the effects of the TMD and its therapeutic care on balance control in various contexts of multi-sensory stimulation, orientation function, pain and tinnitus.
Read the detailed description
Primary objective: to evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle.
- Conditions
- Temporomandibular Disorder, Pathophysiology, Therapy
- Being tested
- Posturography
- Keywords
- Temporo-mandibular dysfunction, Balance control, Orientation function
- Medical subject headings
- Temporomandibular Joint Disorders, Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PosturographyDiagnostic test
Also called Orientation perception
Evaluation of postural control and of orientation function
| Study group | Role | What they receive |
|---|---|---|
| Temporomandibular disorder | Other | Not described Receives: Diagnostic Test: Posturography |
| Without temporomandibular disorder | Other | Not described Receives: Diagnostic Test: Posturography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural control (before care for patients)
Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
Measured: At inclusion (before care for patients) (first evaluation)
Postural control (during care for patients)
Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
Measured: 2 months after the first evaluation
Postural control (during care for patients)
Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
Measured: 3 months after the first evaluation
Postural control (during care for patients)
Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
Measured: 5 months after the first evaluation
Secondary outcomes (4)
Balance function
Length and surface covered by the foot pressure center are measured
Measured: T0 and 2,3 and 5 months after the first evaluation
Orientation function
Orientation is evaluated by the angle between the direction (of the gravity or of a part of his body) indicated by the subject and the real direction. It is evaluated with the road and frame test.
Measured: T0 and 2,3 and 5 months after the first evaluation
Pain
Visual Analog Scale (1 to 10)
Measured: T0 and 2,3 and 5 months after the first evaluation
Tinnitus
Questionnaire
Measured: T0 and 2,3 and 5 months after the first evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start19 Jun 2017
- Primary completion25 Feb 2019 (estimated)
- Study completion25 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283839
- Sponsor's protocol ID
- 2016-A01317-44
- Acronym
- DAM
- Status last verified
- Jan 2018
- First submitted
- 19 May 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Temporomandibular Disorder on Balance Control
- ClinicalTrials.gov ID
- NCT03283839
- Acronym / sponsor ID
- DAM / 2016-A01317-44
- Conditions
- Temporomandibular Disorder, Pathophysiology, Therapy
- Keywords
- Temporo-mandibular dysfunction, Balance control, Orientation function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 25 Feb 2019 (estimated)
- Study completion
- 25 Jun 2020 (estimated)
- First posted
- 14 Sep 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.
To evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle.
Parameters will be estimated by measures realized before the therapeutic care of the TMD (T0), then 2, 3 and 5 months after the starting care, both in TMD patients and control subjects. To evaluate also the effects of the TMD and its therapeutic care on balance control in various contexts of multi-sensory stimulation, orientation function, pain and tinnitus.
Detailed description
Primary objective: to evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporomandibular disorder | Other | Diagnostic Test: Posturography |
| Without temporomandibular disorder | Other | Diagnostic Test: Posturography |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient group: TMD patients, care: occlusal splint therapy, behavioral advices
- Control group: matched with TMD patients (age, sex, lifestyle).
Key exclusion criteria (2 listed)
- Patient group: treatment generating secondary effects in postural control (psychotrop, antidepressor, antihypertensive drugs); osteoarticular pathologies and recent trauma (< 4 months); vertigo and dysequilibrium (< 6 months), whiplash
- Control group: id. and TMD.
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 |
|---|---|---|
| PosturographyAlso: Orientation perceptionEvaluation of postural control and of orientation function | Diagnostic test | Temporomandibular disorder, Without temporomandibular disorder |
Primary outcome
Postural control (before care for patients)
Time frame: At inclusion (before care for patients) (first evaluation)
Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
Postural control (during care for patients)
Time frame: 2 months after the first evaluation
Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
Postural control (during care for patients)
Time frame: 3 months after the first evaluation
Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
Postural control (during care for patients)
Time frame: 5 months after the first evaluation
Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
4 secondary outcomes
Balance function
Time frame: T0 and 2,3 and 5 months after the first evaluation
Orientation function
Time frame: T0 and 2,3 and 5 months after the first evaluation
Pain
Time frame: T0 and 2,3 and 5 months after the first evaluation
Tinnitus
Time frame: T0 and 2,3 and 5 months after the first evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posturography in people with Temporomandibular Disorder and Pathophysiology, run by Central Hospital, Nancy, France 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 2 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: status not confirmed, as of the sponsor's last update on 18 Jan 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe PERRIN (00 33 3 83 15 49 68, philippe.perrin@univ-lorraine.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural control (before care for patients) (time frame: At inclusion (before care for patients) (first evaluation)). The study lists 4 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 18 Jan 2018.