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An Investigation Of The Relationship Between Temporomandibular Disorder With Posture And Pedobarographic Analysis

Primary Purpose

Temporomandibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Postural Analysis
plantar pressure analysis
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Temporomandibular Disorder focused on measuring Plantar Pressure Distribution, Posture, Posturescreen Mobile, RDC/TMD, TMD

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of Temporomandibular Diseases
  • clinical diagnosis of healthy temporomandibular joint

Exclusion Criteria:

  • Trauma history
  • Anatomic deformities and skeletal system fractures
  • Orthopedic or rheumatic diseases diagnosed
  • Pregnancy
  • Having TMR treatment
  • Being included in the physiotherapy program in the last 6 months

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

TMD Group

Control Group

Arm Description

people who has TMD

individuals who dont have healthy temporomandibular joint

Outcomes

Primary Outcome Measures

flexion and extension degree
degree
translation
cm

Secondary Outcome Measures

plantar pressure distribution
kPa

Full Information

First Posted
March 25, 2018
Last Updated
July 20, 2018
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03490643
Brief Title
An Investigation Of The Relationship Between Temporomandibular Disorder With Posture And Pedobarographic Analysis
Official Title
Temporomandibular Rahatsızlığın Postür ve Pedobarografik Ölçüm Sonuçları Ile İlişkisinin Araştırılması
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 28, 2018 (Actual)
Primary Completion Date
May 10, 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is, to evaluate the whole body posture and plantar pressure distributions in individuals with Temporomandibular Disorder and also in people with healthy temporomandibular joints. A study group aged between 18-35 years, 30 patients, who were diagnosed with Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) who applied us with jaw pain and 30 healthy people at the same age range as a control group were included in the study. Both groups received global postural assessments by using PostureScreen Mobile® (PSM) program which is using four side photographs and the New York Posture Scale (NYPS). Static pedobarographic measurements were taken.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
Plantar Pressure Distribution, Posture, Posturescreen Mobile, RDC/TMD, TMD

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMD Group
Arm Type
Other
Arm Description
people who has TMD
Arm Title
Control Group
Arm Type
Other
Arm Description
individuals who dont have healthy temporomandibular joint
Intervention Type
Other
Intervention Name(s)
Postural Analysis
Intervention Description
posture and plantar pressure analysis
Intervention Type
Other
Intervention Name(s)
plantar pressure analysis
Intervention Description
posture and plantar pressure analysis
Primary Outcome Measure Information:
Title
flexion and extension degree
Description
degree
Time Frame
5 minutes
Title
translation
Description
cm
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
plantar pressure distribution
Description
kPa
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of Temporomandibular Diseases clinical diagnosis of healthy temporomandibular joint Exclusion Criteria: Trauma history Anatomic deformities and skeletal system fractures Orthopedic or rheumatic diseases diagnosed Pregnancy Having TMR treatment Being included in the physiotherapy program in the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gizem Ergezen
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zeliha Candan Algun
Organizational Affiliation
Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
34810
Country
Turkey

12. IPD Sharing Statement

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An Investigation Of The Relationship Between Temporomandibular Disorder With Posture And Pedobarographic Analysis

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