The Effect Of Core Stability Training In Temporomandibula... | NCT04755621

Studies
The Effect Of Core Stability Training In Temporomandibular Disorders

NCT04755621

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Status

Completed

Last Update Posted

Feb 16, 2021Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Temporomandibular Disorder

Interventions

Core stability training
Rocabado Exercises

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

Feb 2021

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 1, 2019Actual

Primary Completion Date

Aug 1, 2019Actual

Completion Date

Sep 1, 2019Actual

First Submitted Date

Jan 28, 2021

First Submission Date that Met QC Criteria

Feb 12, 2021

First Posted Date

Feb 16, 2021Actual

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

Feb 12, 2021

Last Update Posted Date

Feb 16, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emre Serdar Atalay, Assist. Prof., Saglik Bilimleri UniversitesiPrincipal Investigator

Lead Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyOTHER

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

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.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Core stability Group	Experimental		Other: Core stability training
Control Group	Active Comparator		Other: Rocabado Exercises

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Core stability training	Other	Core stability exercises	Core stability Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Foot Posture	Foot Posture Index-6	6 weeks
Graded Pain	Graded Chronic Pain Scale	6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emre Serdar Atalay, PhD	University of Health Sciences, Physical Therapy and Rehabilitation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University and Health Sciences Physical Therapy and Rehabilitation		Istanbul	Uskudar	34668	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37924356	Derived	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.

ID	Term
D013705	Temporomandibular Joint Disorders
D010146	Pain

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