Temporomandibular Dysfunction in Patients With Cervical D... | NCT06141863

Studies
Temporomandibular Dysfunction in Patients With Cervical Disc Herniation

NCT06141863

Sponsor

Karadeniz Technical University

Status

Completed

Last Update Posted

Nov 21, 2023Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Temporomandibular Joint Dysfunction Syndrome

Interventions

questionnaire

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

Nov 2023

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

May 1, 2022Actual

Primary Completion Date

Nov 30, 2022Actual

Completion Date

Dec 30, 2022Actual

First Submitted Date

Nov 15, 2023

First Submission Date that Met QC Criteria

Nov 20, 2023

First Posted Date

Nov 21, 2023Actual

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

Nov 20, 2023

Last Update Posted Date

Nov 21, 2023Actual

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

Cervical spine problems are associated with temporomandibular joint (TMJ) and related muscles.The aim of the present study was to investigate temporomandibular joint dysfunction (TMD) and pain in individuals with cervical disc herniation (CDH) according to the level of neck disability.

Detailed Description

The study included diagnosed with cervical disc herniation. The participants were divided into two groups based on their The Neck Disability Index (NDI) score: Group 1 with no disability and mild disability and Group 2 with moderate and severe disability. Temporomandibular dysfunction and its severity, intensity of neck and temporomandibular joint pain was assessed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		no disability and mild disability	Other: questionnaire
Group 2		moderate and severe disability	Other: questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire	Other	Neck Disability Index, The Fonseca Anamnestic Index (FAI) and Visual Analogue Scale (VAS)	Group 1 Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neck Disability Index	Assessment of neck disability	one day assessment
Fonseca Anamnestic Index	Assessment of temporomandibular dysfunction	one day assessment

Secondary Outcomes

Measure	Description	Time Frame
Visual Analogue Scale	Assessment of temporomandibular joint pain and neck pain intensity	one day assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with cervical disc herniation aged between 18 and 65,
who could read and write in Turkish

Exclusion Criteria:

Individuals with a history of head and neck surgery, fracture, physiotherapy or medical treatment cervical or temporomandibular joint treatment within the last six months,
presence of any inflammatory rheumatic diseases, such as ankylosing spondylitis and rheumatoid arthritis, facial paralysis, infection, advanced osteoporosis

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Individuals diagnosed with cervical disc herniation. Patients who were referred to physiotherapy after diagnosis were evaluated in terms of study suitability before starting treatment. We divided the participants into two groups based on their level of neck disability to compare their TMD.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Turgay Altunalan, Assist Prof	Karadeniz Technical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karadeniz Technical University		Trabzon		61000	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D013706	Temporomandibular Joint Dysfunction Syndrome
D007405	Intervertebral Disc Displacement

Ancestor Terms

ID	Term
D013705	Temporomandibular Joint Disorders
D017271	Craniomandibular Disorders
D008336	Mandibular Diseases
D007571	Jaw Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided