NCT06623552

Brief Summary

The aim of this study is to examine temporomandibular dysfunctions, jaw functional limitation, cervical mobility and craniovertebral angles and possible relations between individuals with cervical pain and individuals without cervical pain and to compare the this four variables between the two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-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 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

September 30, 2024

Last Update Submit

October 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Neck Pain and Disability Scale (NPDS):

    one day

Secondary Outcomes (1)

  • Fonseca Anamnestic Index (FAI):

    one day

Study Arms (2)

Control Group

the population without cervical pain or with a cut off value of less than 15 for neck pain and disability score(NPDS) were selected as the control group

Other: Neck Pain and Disability Scale (NPDS)Other: Fonseca Anamnestic Index (FAI)Other: Evaluation of Jaw Functional Limitation

Study Group

the population without cervical pain or with a cut off value of more than 15 for neck pain and disability score(NPDS) were selected as the study group

Other: Neck Pain and Disability Scale (NPDS)Other: Fonseca Anamnestic Index (FAI)Other: Evaluation of Jaw Functional Limitation

Interventions

The Turkish version of the Neck Pain and Disability Scale (NPDS), developed by Wheeler et al., was used for individuals with neck pain. The severity of neck pain is evaluated on a 5-point Likert scale; where 0 indicates "no pain" and 4 indicates "very severe pain". The score is higher in those with upper extremity symptoms.The cut-off value of this scale was set to 15 to detect disability-related neck pain.The cut-off value is mandatory to evaluate a patient or a particular group of patients for clinically significant neck pain by distinguishing it from insignificant pain

Control GroupStudy Group

It is a questionnaire consisting of 10 questions, including pain during the period, parafunctional habits, movement restriction, clicking, malocclusion, emotional stress.In this study, clinical signs relevant to each severity category of Fonseca's anamnestic index were used to detect the frequency of symptoms and to characterize the symptoms and clinical findings of TMD.The Turkish version of Fonseca's Anamnestic Index (FAI) questionnaire was used to assess the symptom severity.

Control GroupStudy Group

The Jaw Functional Limitation Scale (JFLS) was developed as an 8-item scale for general functional limitation in the jaw. In the light of the obtained items and supporting psychometric data, it has been expanded and re-developed to include the verbal and non-verbal communication limitations that occur in a 20-item tool16 JFLS-20 is a tool with three structure contents (chewing, vertical mobility of jaw state and emotional and verbal statement) to evaluate functional state.Difficulty performing a determined task is graded from 0 (without limitation) to 10 (severe limitation). Higher scores are a more serious sign of functional limitation.

Control GroupStudy Group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All individuals in the study were included on a voluntary basis.All participants were informed about the study before the evaluations and the consent form was signed (Appendix- ).All necessary evaluations for the study were carried out on the same day.During the study, both the participants in the study group and the participants in the control group completed the evaluation completely.No health problems were observed in any participant during and after the evaluations.

You may qualify if:

  • Neck pain disability score below 15 Not having painting problem for TME Being in the age range of 18-50 Volunteering to participate in the study

You may not qualify if:

  • he presence of any orthopedic and / or neurological problem that may prevent evaluations.
  • Being diagnosed with any psychiatric disorder Situations that will prevent evaluation or communication
  • Illiterate individuals
  • Head, neck and maxillofacial surgery operation history
  • Conditions in systemic pathological conditions such as malignant condition, fracture and rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2024

First Posted

October 2, 2024

Study Start

November 1, 2020

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

October 2, 2024

Record last verified: 2024-09

Locations