The Influence of a Stabilization Splint on the Body Posture

Chronic Disease Clinical Trial

Official title:

The Influence of of a Stabilization Splint on the Body Posture in TMD Cases and Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154128
• Other study ID #: RD-B-01
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2005
• Last updated: November 17, 2005
• Start date: April 2005
• Est. completion date: August 2005

Study information

• Verified date: September 2005
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• TMD cases: chronic systemic diseases, cardiac pacemakers

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthromyalgia
• Chronic Disease
• Craniomandibular Disorders
• Disease
• Occlusal Appliance
• Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
• occlusal appliance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in body posture
Secondary	score of compliants
Secondary	number of tender muscles and TMJs