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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | September 8, 2005 | ||||||||||||
| Last Updated Date | November 17, 2005 | ||||||||||||
| Start Date ICMJE | April 2005 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE |
changes in body posture | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00154128 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | The Influence of a Stabilization Splint on the Body Posture | ||||||||||||
| Official Title ICMJE | The Influence of of a Stabilization Splint on the Body Posture in TMD Cases and Controls | ||||||||||||
| Brief 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. Changes of the mandibular position and occlusal equilibrations are assumed to have an impact on the general body posture. |
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| 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. |
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| Study Phase | Phase I | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Non-Randomized, Single Blind, Uncontrolled, Parallel Assignment, Efficacy Study | ||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | Device: occlusal appliance | ||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 40 | ||||||||||||
| Completion Date | August 2005 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years to 65 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | |||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00154128 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | RD-B-01 | ||||||||||||
| Study Sponsor ICMJE | Ernst Moritz Arndt University of Greifswald | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | Ernst Moritz Arndt University of Greifswald | ||||||||||||
| Verification Date | September 2005 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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