The Influence of a Stabilization Splint on the Body Posture

This study has been completed.
Sponsor:
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00154128
First received: September 8, 2005
Last updated: November 17, 2005
Last verified: September 2005
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Influence of of a Stabilization Splint on the Body Posture in TMD Cases and Controls

Resource links provided by NLM:


Further study details as provided by University Medicine 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
University Medicine 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
  More Information

No publications provided

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

Keywords provided by University Medicine Greifswald:
temporomandibular disorder
craniomandibular disorder
occlusal appliance
clinical trial

Additional relevant MeSH terms:
Chronic Disease
Craniomandibular Disorders
Disease
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Disease Attributes
Jaw Diseases
Joint Diseases
Mandibular Diseases
Muscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Pathologic Processes
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 23, 2014