NCT04755621

Brief Summary

This study is to investigate the effect of Core stability training on pain, function, quality of life, sleep quality, body posture, foot posture, oral habits and kinesiophobia in individuals with temporomandibular disorder. Materials and Methods: The study included 40 people over the age of 18, who were diagnosed with temporomandibular disorder from the dentist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

January 28, 2021

Last Update Submit

February 12, 2021

Conditions

Temporomandibular Disorder

Keywords

core stabilitypainquality of lifefunctiontemporomandibular disorder

Outcome Measures

Primary Outcomes (5)

  • Posture

    New York Posture Scale

    6 weeks

  • Sleep Quality

    Pittsburg Sleep Quality Index

    6 weeks

  • Kinesiophobia

    Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD)

    6 weeks

  • Oral Habits

    Oral Behavior Checklist

    6 weeks

  • Jaw Function

    Jaw Functional Limitation Scale-20

    6 weeks

Secondary Outcomes (2)

  • Foot Posture

    6 weeks

  • Graded Pain

    6 weeks

Study Arms (2)

Core stability Group

EXPERIMENTAL
Other: Core stability training

Control Group

ACTIVE COMPARATOR
Other: Rocabado Exercises

Interventions

Core stability trainingOTHER

Core stability exercises

Core stability Group
Rocabado ExercisesOTHER

Exercises for Temporomandibular Disorders

Control Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female patients aged 18-55, diagnosed with temporomandibular disease by a dentist

You may not qualify if:

  • Having received another treatment for TMR other than the use of night plate in the last 6 months
  • Having a disease that can cause facial pain such as sinusitis, migraine, tension headache, trigeminal neuralgia
  • Skeletal system fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University and Health Sciences Physical Therapy and Rehabilitation

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

Related Publications (1)

  • Seyhan M, Atalay ES. Is core stability training effective in temporomandibular disorder? A randomized controlled trial. Clin Oral Investig. 2023 Dec;27(12):7237-7246. doi: 10.1007/s00784-023-05274-x. Epub 2023 Nov 4.

    PMID: 37924356DERIVED

MeSH Terms

Conditions

Temporomandibular Joint DisordersPain

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emre Serdar Atalay, PhD

    University of Health Sciences, Physical Therapy and Rehabilitation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 16, 2021

Study Start

April 1, 2019

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

February 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)