The Influence of a Stabilization Splint on the Body Posture
Primary Purpose
Temporomandibular Disorders, Craniomandibular Disorders, Arthromyalgia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
occlusal appliance
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorders focused on measuring temporomandibular disorder, craniomandibular disorder, occlusal appliance, clinical trial
Eligibility Criteria
Inclusion Criteria: TMD cases: diagnoses of myofascial pain and/or arthralgia Exclusion Criteria: TMD cases: chronic systemic diseases, cardiac pacemakers
Sites / Locations
Outcomes
Primary Outcome Measures
changes in body posture
Secondary Outcome Measures
score of compliants
number of tender muscles and TMJs
Full Information
NCT ID
NCT00154128
First Posted
September 8, 2005
Last Updated
November 17, 2005
Sponsor
University Medicine Greifswald
1. Study Identification
Unique Protocol Identification Number
NCT00154128
Brief Title
The Influence of a Stabilization Splint on the Body Posture
Official Title
The Influence of of a Stabilization Splint on the Body Posture in TMD Cases and Controls
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Medicine Greifswald
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders, Craniomandibular Disorders, Arthromyalgia, Chronic Disease, Occlusal Appliance
Keywords
temporomandibular disorder, craniomandibular disorder, occlusal appliance, clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
occlusal appliance
Primary Outcome Measure Information:
Title
changes in body posture
Secondary Outcome Measure Information:
Title
score of compliants
Title
number of tender muscles and TMJs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
TMD cases: diagnoses of myofascial pain and/or arthralgia
Exclusion Criteria:
TMD cases: chronic systemic diseases, cardiac pacemakers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Meyer, Prof.
Organizational Affiliation
School of Dentistry, University of Greifswald, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georg Meyer, Prof. Dr.
Organizational Affiliation
School of Dentistry, University of Greifswald
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Influence of a Stabilization Splint on the Body Posture
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