Temporomandibular DisordersPhase 1NCT00154128
The Influence of a Stabilization Splint on the Body Posture
A Phase 1 study testing occlusal appliance in people with Temporomandibular Disorders and Craniomandibular Disorders, run by University Medicine Greifswald.
Trial summary
The study was designed to investigate a possible influence of an occlusal stabilization splint on the body posture in TMD cases and controls. Interocclusal appliances or occlusal splints are therapeutic devices that are most frequently used in the treatment of TMD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders, Craniomandibular Disorders, Arthromyalgia
- What is being tested?
- occlusal appliance
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Aug 2005
- Phase
- Phase 1
- 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
- TMD cases: diagnoses of myofascial pain and/or arthralgia
Who cannot join
- TMD cases: chronic systemic diseases, cardiac pacemakers
About this study
Official title: The Influence of of a Stabilization Splint on the Body Posture in TMD Cases and Controls
The study was designed to investigate a possible influence of an occlusal stabilization splint on the body posture in TMD cases and controls. Interocclusal appliances or occlusal splints are therapeutic devices that are most frequently used in the treatment of TMD. Changes of the mandibular position and occlusal equilibrations are assumed to have an impact on the general body posture.
Read the detailed description
Thirty TMD cases and 10 controls were included in the study. All participants were recruited from the School of Dentistry, University of Greifswald. All subjects gave their written consent to participate in the study. They then completed a TMD history questionnaire and underwent a clinical examination. The examination included palpation of the masticatory muscles and the TMJs, range of mandibular motion measurements, and assessment of joint noises. The TMD cases were required to have a diagnoses of myofascial pain and/or arthralgia. Controls had to be free of pain symptoms in their masticatory muscles and TMJs. Body posture was measured during five minutes of walking using an ultrasound-distance measuring device (sonoSens® Monitor) with small sensors placed on the skin that continually record changes in the distance between them. A static posture evaluation was performed with a contactless, and radiation-free static measurement of the back surface and spine using a 3D measurement system (formetric II). A second measurement was performed after insertion of the occlusal appliance and a third one after 7 days of treatment.
The occlusal appliances were inserted after the first examination and all participants were instructed to use it at night and during examinations.
- Conditions
- Temporomandibular Disorders, Craniomandibular Disorders, Arthromyalgia, Chronic Disease, Occlusal Appliance
- Being tested
- occlusal appliance
- Keywords
- temporomandibular disorder, craniomandibular disorder, occlusal appliance, clinical trial
- Medical subject headings
- Temporomandibular Joint Disorders, Craniomandibular Disorders, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occlusal applianceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in body posture
Secondary outcomes (2)
score of compliants
number of tender muscles and TMJs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Investigators
- Georg Meyer, Prof., Principal investigator, School of Dentistry, University of Greifswald, GermanyGeorg Meyer, Prof. Dr., Principal investigator, School of Dentistry, University of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154128
- Sponsor's protocol ID
- RD-B-01
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 18 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of of a Stabilization Splint on the Body Posture in TMD Cases and Controls
- ClinicalTrials.gov ID
- NCT00154128
- Acronym / sponsor ID
- RD-B-01
- Conditions
- Temporomandibular Disorders, Craniomandibular Disorders, Arthromyalgia, Chronic Disease, Occlusal Appliance
- Keywords
- temporomandibular disorder, craniomandibular disorder, occlusal appliance, clinical trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Aug 2005
- First posted
- 12 Sep 2005 (estimated)
- 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.
The study was designed to investigate a possible influence of an occlusal stabilization splint on the body posture in TMD cases and controls. Interocclusal appliances or occlusal splints are therapeutic devices that are most frequently used in the treatment of TMD. Changes of the mandibular position and occlusal equilibrations are assumed to have an impact on the general body posture.
Detailed description
Thirty TMD cases and 10 controls were included in the study. All participants were recruited from the School of Dentistry, University of Greifswald. All subjects gave their written consent to participate in the study. They then completed a TMD history questionnaire and underwent a clinical examination. The examination included palpation of the masticatory muscles and the TMJs, range of mandibular motion measurements, and assessment of joint noises. The TMD cases were required to have a diagnoses of myofascial pain and/or arthralgia. Controls had to be free of pain symptoms in their masticatory muscles and TMJs. Body posture was measured during five minutes of walking using an ultrasound-distance measuring device (sonoSens® Monitor) with small sensors placed on the skin that continually record changes in the distance between them. A static posture evaluation was performed with a contactless, and radiation-free static measurement of the back surface and spine using a 3D measurement system (formetric II). A second measurement was performed after insertion of the occlusal appliance and a third one after 7 days of treatment.
The occlusal appliances were inserted after the first examination and all participants were instructed to use it at night and during examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- TMD cases: diagnoses of myofascial pain and/or arthralgia
Key exclusion criteria (1 listed)
- TMD cases: chronic systemic diseases, cardiac pacemakers
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 |
|---|---|---|
| occlusal appliance | Device | – |
Primary outcome
changes in body posture
2 secondary outcomes
score of compliants
number of tender muscles and TMJs
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 18 Nov 2005.
Related trials for Temporomandibular Disorders
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
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.
Georg Meyer, Prof. principal investigator
School of Dentistry, University of Greifswald, Germany
Georg Meyer, Prof. Dr. principal investigator
School of Dentistry, University of Greifswald
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing occlusal appliance in people with Temporomandibular Disorders and Craniomandibular Disorders, run by University Medicine Greifswald.
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 1 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 18 Nov 2005. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
changes in body posture. 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 Nov 2005.