NCT03490643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

April 28, 2018

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
Last Updated

July 23, 2018

Status Verified

May 1, 2018

Enrollment Period

12 days

First QC Date

March 25, 2018

Last Update Submit

July 20, 2018

Conditions

Keywords

Plantar Pressure DistributionPosturePosturescreen MobileRDC/TMDTMD

Outcome Measures

Primary Outcomes (2)

  • flexion and extension degree

    degree

    5 minutes

  • translation

    cm

    5 minutes

Secondary Outcomes (1)

  • plantar pressure distribution

    2 minutes

Study Arms (2)

TMD Group

OTHER

people who has TMD

Other: Postural AnalysisOther: plantar pressure analysis

Control Group

OTHER

individuals who dont have healthy temporomandibular joint

Other: Postural AnalysisOther: plantar pressure analysis

Interventions

posture and plantar pressure analysis

Control GroupTMD Group

posture and plantar pressure analysis

Control GroupTMD Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Gizem Ergezen

    Medipol University

    PRINCIPAL INVESTIGATOR
  • Zeliha Candan Algun

    Medipol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT. MSc. PhD (Candidate)

Study Record Dates

First Submitted

March 25, 2018

First Posted

April 6, 2018

Study Start

April 28, 2018

Primary Completion

May 10, 2018

Study Completion

May 15, 2018

Last Updated

July 23, 2018

Record last verified: 2018-05

Locations