An Investigation Of The Relationship Between Temporomandi... | NCT03490643

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

NCT03490643

Sponsor

Istanbul Medipol University Hospital

Status

Completed

Last Update Posted

Jul 23, 2018Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Temporomandibular Disorder

Interventions

Postural Analysis
plantar pressure analysis

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 28, 2018Actual

Primary Completion Date

May 10, 2018Actual

Completion Date

May 15, 2018Actual

First Submitted Date

Mar 25, 2018

First Submission Date that Met QC Criteria

Mar 30, 2018

First Posted Date

Apr 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2018

Last Update Posted Date

Jul 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

gizem ergezen, PT. MSc. PhD (Candidate), Istanbul Medipol University HospitalPrincipal Investigator

Lead Sponsor

Istanbul Medipol University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TMD Group	Other	people who has TMD	Other: Postural Analysis Other: plantar pressure analysis
Control Group	Other	individuals who dont have healthy temporomandibular joint	Other: Postural Analysis Other: plantar pressure analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Postural Analysis	Other	posture and plantar pressure analysis	Control Group TMD Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
flexion and extension degree	degree	5 minutes
translation	cm	5 minutes

Secondary Outcomes

Measure	Description	Time Frame
plantar pressure distribution	kPa	2 minutes

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gizem Ergezen	Medipol University	Principal Investigator
Zeliha Candan Algun	Medipol University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Medipol University		Istanbul	Beykoz	34810	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D013705	Temporomandibular Joint Disorders

Ancestor Terms

ID	Term
D017271	Craniomandibular Disorders
D008336	Mandibular Diseases
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided