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The Influence of a Stabilization Splint on the Body Posture

This study has been completed.

Sponsored by: Ernst Moritz Arndt University of Greifswald
Information provided by: Ernst Moritz Arndt University of Greifswald
ClinicalTrials.gov Identifier: NCT00154128
  Purpose

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.


Condition Intervention Phase
Temporomandibular Disorders
Craniomandibular Disorders
Arthromyalgia
Chronic Disease
Occlusal Appliance
Device: occlusal appliance
Phase I

MedlinePlus related topics:   Coping with Chronic Illness    Temporomandibular Joint Dysfunction   

ChemIDplus related topics:   Salicylic acid   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Single Blind, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:   The Influence of of a Stabilization Splint on the Body Posture in TMD Cases and Controls

Further study details as provided by Ernst Moritz Arndt University of Greifswald:

Primary Outcome Measures:
  • changes in body posture

Secondary Outcome Measures:
  • score of compliants
  • number of tender muscles and TMJs

Estimated Enrollment:   40
Study Start Date:   April 2005
Estimated Study Completion Date:   August 2005

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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • TMD cases: diagnoses of myofascial pain and/or arthralgia

Exclusion Criteria:

  • TMD cases: chronic systemic diseases, cardiac pacemakers
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154128

Sponsors and Collaborators
Ernst Moritz Arndt University of Greifswald

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    
Principal Investigator:     Georg Meyer, Prof. Dr.     School of Dentistry, University of Greifswald    
  More Information

Study ID Numbers:   RD-B-01
First Received:   September 8, 2005
Last Updated:   November 17, 2005
ClinicalTrials.gov Identifier:   NCT00154128
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ernst Moritz Arndt University of Greifswald:
temporomandibular disorder  
craniomandibular disorder  
occlusal appliance  
clinical trial  

Study placed in the following topic categories:
Temporomandibular Joint Disorders
Muscular Diseases
Musculoskeletal Diseases
Temporomandibular Joint Dysfunction Syndrome
Myofascial Pain Syndromes
Fibromyalgia
Joint Diseases
Craniomandibular Disorders
Salicylic Acid
Pain
Chronic Disease
Stomatognathic Diseases

Additional relevant MeSH terms:
Mandibular Diseases
Disease Attributes
Pathologic Processes
Disease
Jaw Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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