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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
University Medicine Greifswald
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 8, 2005
    Last Updated
    November 17, 2005
    Sponsor
    University Medicine Greifswald
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    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

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    The Influence of a Stabilization Splint on the Body Posture

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