NCT04948320

Brief Summary

The temporomandibular joint (TMJ), is the only movable joint between the joints in the head and neck system. It is a component of the chewing system and is involved in important functions such as speech, swallowing, taste and breathing. Temporomandibular dysfunction (TMD) is the general name given to various musculoskeletal problems seen in the stomatognathic system, mostly affecting the masticatory muscles and/or TMJ. TMD is the second most common musculoskeletal pain after chronic low back pain. Patients with TMD may also complain of other musculoskeletal problems, craniocervical problems, sleep problems, and anxiety disorders. The aim of this study is to investigate, compare and examine the relationship between neck dysfunction, headache and temporomandibular dysfunction severity, anxiety and sleep quality in female individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

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

November 25, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

June 27, 2021

Last Update Submit

June 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pittsburgh Sleep Quality Index

    Baseline

Secondary Outcomes (5)

  • Fonseca Anamnestic Index

    Baseline

  • Numerical Rating Scale

    Baseline

  • Neck Disability Index

    Baseline

  • Headache Impact Test

    baseline

  • General Anxiety Disorder-7 Scale

    baseline

Study Arms (2)

Temporomandibular Disorder Group

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

temporomandibular disorder and healthy women

You may qualify if:

  • Between 18 and 65 years
  • Temporomandibular disorders more than 6 months
  • Volunteering

You may not qualify if:

  • Cranio-cervical trauma and temporomandibular operation history
  • Infection
  • points from Fonseca Anamnestic Index 20-40 points

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersHeadacheAnxiety DisordersSleep Wake Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 1, 2021

Study Start

November 25, 2020

Primary Completion

January 25, 2021

Study Completion

January 25, 2021

Last Updated

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations