- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00154128
The Influence of a Stabilization Splint on the Body Posture
The Influence of of a Stabilization Splint on the Body Posture in TMD Cases and Controls
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- TMD cases: diagnoses of myofascial pain and/or arthralgia
Exclusion Criteria:
- TMD cases: chronic systemic diseases, cardiac pacemakers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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changes in body posture
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Secondary Outcome Measures
Outcome Measure |
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|
score of compliants
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number of tender muscles and TMJs
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Georg Meyer, Prof., School of Dentistry, University of Greifswald, Germany
- Principal Investigator: Georg Meyer, Prof. Dr., School of Dentistry, University of Greifswald
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Mandibular Diseases
- Myofascial Pain Syndromes
- Disease
- Chronic Disease
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Craniomandibular Disorders
- Anti-Infective Agents
- Dermatologic Agents
- Antifungal Agents
- Keratolytic Agents
- Salicylic Acid
Other Study ID Numbers
- RD-B-01
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