Temporamandibular Joint Functions and Parafunctional Habits | NCT05580276

Studies
Temporamandibular Joint Functions and Parafunctional Habits

NCT05580276

Sponsor

Karadeniz Technical University

Status

Completed

Last Update Posted

Oct 4, 2023Actual

Enrollment

48Actual

Phase

Not provided

Conditions

Headache
Temporomandibular Disorder

Interventions

Not provided

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

Oct 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

Mar 10, 2022Actual

Primary Completion Date

Jan 30, 2023Actual

Completion Date

Mar 13, 2023Actual

First Submitted Date

Sep 28, 2022

First Submission Date that Met QC Criteria

Oct 13, 2022

First Posted Date

Oct 14, 2022Actual

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

Oct 2, 2023

Last Update Posted Date

Oct 4, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nurhayat KORKMAZ, Research assistant, Karadeniz Technical UniversityPrincipal Investigator

Lead Sponsor

Karadeniz Technical UniversityOTHER

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

Headache is the most common type of pain in children and adolescents with effects on health-related quality of life (HrQoL), school attendance, and social functioning. The International Headache Society recognizes that secondary headaches can be attributed to temporamandibular joint (TMJ) problems. The primary aim of the study is to evaluate temporamandibular joint functions and parafunctional habits in adolescents with headache. The second aim is to examine the relationship between temporamandibular joint functions and parafunctional habits and headache.

Detailed Description

24 individuals under the age of 18 diagnosed with headache and 24 healthy controls will be included in the study. Age, height, weight characteristics and parafunctional habits of individuals will be recorded. The severity of headache and its effect on daily life, temporamandibular joint pain severity will be evaluated. Temporamandibular joint dysfunction severity will be determined and mouth openings will be measured.

Participants who meet the inclusion criteria will be included in the study group. Healthy volunteers without headache complaints will also be included in the study as a control group.In this study, which is planned to include those who meet the inclusion criteria and agree to participate in the study, written informed consent form will be obtained from all individuals and from their parents for those under the age of 18. The study will be carried out in accordance with the ethical principles of the Declaration of Helsinki. The study will be done through a questionnaire form and with anthropetric measurements. No invasive procedure will be applied. A p value of ≤0.05 will be considered significant in all statistics.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		Adolescent with headache, 10-18 ages
Control group		Adolescent without headache

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Headache Impact Test (HIT-6)		1 day (one assessment)
Temporomandibular dysfunction	Fonseca Anamnestic Index. No dysfunction, mild, moderate, severe	1 day (one assessment)

Secondary Outcomes

Measure	Description	Time Frame
Wong Baker Pain Scale	Severity of Headache	1 day (one assessment)
Mouth opening measurement	Maximum painless mouth opening width and lateral deviations from the distance between the two anterior incisors in the lower and upper palate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Being diagnosed with headache according to the ICDH-II (International Classification of Headache Disorders 2nd edition) criteria published by IHS (International Headache Society) in 2004
Having a headache complaint in the last 3 months
Having a HIT-6 score of 50 or higher

Exclusion Criteria:

Being on any analgesic, anti-sedative, myorelaxant medication
Those with mental and psychiatric problems

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Adolescents 10-18 years old with headache and without headache

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elif Acar Arslan, Assoc. Prof	Karadeniz Technical University	Study Director

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006261	Headache
D013705	Temporomandibular Joint Disorders

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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