NCT04435951

Brief Summary

The aim of this study was to investigate the effects of temporomandibular joint dysfunction (TMJD) on pain, quality of life and psychological status. A total of one hundred twenty people participated in the study, sixty with TMJD symptoms (according to the Research Diagnostic Criteria for Temporomandibular Disorders) and sixty without TMJD symptoms. The severity of temporomandibular joint (TMJ) pain and headache was assessed using a visual analog scale (VAS), pain threshold using an algometer, anxiety and depression levels with the Hospital Anxiety and Depression Scale (HADS), and the quality of life level was assessed by Short Form-36 (SF-36). Treatment of TMJD with appropriate therapies and psychological support techniques may reduce TMJD symptoms and improve patients' quality of life and psychological status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Typical duration 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

March 6, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2017

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 5, 2020

Last Update Submit

June 15, 2020

Conditions

Keywords

Temporomandibular jointDysfunctionPainQuality of life

Outcome Measures

Primary Outcomes (1)

  • Temporomandibular joint pain severity and headache severity

    Individuals in both groups were asked to mark TMJ pain and headache on a 10 cm straight line using a visual analogue scale (VAS), and the results were recorded in cm. Patients were asked about pain in bilateral resting and mobile positions of the TMJ. On the VAS scale, "0" indicates no pain, and "10" the most severe pain possible.

    5 months

Secondary Outcomes (2)

  • Psychological status (anxiety and depression levels)

    5 months

  • Short Form-36

    5 months

Study Arms (2)

Group 1 (with TMJD)

Group 1, consists of 60 patients diagnosed with Temporomandibular Joint Dysfunction (TMJD) according to the Research Diagnostic Criteria for Temporomandibular Disorders by a specialist and experienced dentist in TMJD.

Other: Evaluation

Group 2 (without TMJD)

Group 2, consists of 60 individuals who did not exhibit TMJD symptoms and have not TMJD diagnosis.

Other: Evaluation

Interventions

No attempt was made to the individuals in Group 1 and Group 2. Individuals were only evaluated.

Group 1 (with TMJD)Group 2 (without TMJD)

Eligibility Criteria

Age17 Years - 57 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Group 1 (60 patients, group with TMJD) consists of patients diagnosed with TMJD according to the Research Diagnostic Criteria for Temporomandibular Disorders by a specialist and experienced dentist in TMJD. Group 2 (60 healthy individuals, group without TMJD) consists of individuals who are evaluated by a specialist and experienced dentist in TMJD and who do not show symptoms of TMJD.

You may qualify if:

  • For Group 1 (group with TMJD):
  • Patients diagnosed with TMJD
  • Able to understand and speak Turkish and cooperate
  • Aged 17 years or older and 65 years or younger
  • Patients have articular sounds in the form of clicks or crepitation from the TMJ during mouth opening or chewing
  • Sensitivity and pain in the TMJ at palpation
  • Not receiving TMJ treatment in the past six months
  • Presence of TMJD symptoms for at least three months For Group 2 (group without TMJD)
  • Able to understand and speak Turkish and cooperate
  • Aged 17 years or aged 17 years or older and 65 years or younger
  • Maximum mouth opening 30 mm or more
  • Absence of articular sounds such as TMJ click or crepitation during mouth opening and closing and/or chewing activity.
  • Absence of tenderness and pain in the TMJ and chewing muscles at palpation

You may not qualify if:

  • For Group 1 (group with TMJD):
  • Absence of at least one of the TMJD symptoms
  • Presence of a history of tumor, cervical discopathy, orthopedic and rheumatic pathologies, head, neck and/or jaw surgery and pregnancy For Group 2 (group without TMJD)
  • Presence of at least one of the symptoms of TMJD
  • Presence of a history of tumor, cervical discopathy, orthopedic and rheumatic pathologies, head, neck and/or jaw surgery and pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (42)

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    RESULT
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    RESULT
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    RESULT
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MeSH Terms

Conditions

Temporomandibular Joint DisordersPain

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nazım Tolgahan YILDIZ, MSc

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Bahar KÜLÜNKOĞLU, PhD

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 17, 2020

Study Start

March 6, 2017

Primary Completion

July 24, 2017

Study Completion

May 25, 2020

Last Updated

June 17, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations