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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05993494
Other study ID # KTU-FTR-2023/6
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2023
Est. completion date July 30, 2024

Study information

Verified date March 2024
Source Karadeniz Technical University
Contact Nurhayat Korkmaz, PhDstudent
Phone +905387369062
Email krkmznrhyt@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Temporomandibular dysfunction (TMD) is a musculoskeletal and neuromuscular system-related condition that affects the masticatory muscles, temporomandibular joint, and other related structures. Recent research has focused specifically on pain catastrophe, kinesiophobia, and central sensitization in individuals with TMD. Therefore, the aim of this study is to examine the relationship between pain, central sensitization, kinesiophobia and stress level in individuals with temporomandibular dysfunction.


Description:

Temporomandibular dysfunction (TMD) is a musculoskeletal and neuromuscular system-related condition that affects the masticatory muscles, temporomandibular joint, and other related structures. Psychological factors are stated as comorbid in individuals with TMD. Individuals with TMD-related pain show higher levels of stress, anxiety, depression, somatic awareness, pain catastrophizing, and kinesiophobia compared to controls. Therefore, recent research has focused on pain catastrophe, kinesiophobia, and central sensitization, especially in individuals with TMD. Therefore, the aim of this study is to examine the relationship between pain, central sensitization, kinesiophobia and stress level in individuals with temporomandibular dysfunction. Ninety patients aged 18-65 years, who have TME-related complaints for at least 3 months, and diagnosed with TMD as a result of clinical and radiological evaluation by a dentist will be included in the study.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date July 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Between the ages of 18-65, - Having complaints related to TMJ for at least 3 months, - Patients diagnosed with TMD as a result of clinical and radiological evaluation by the dentist Exclusion Criteria: - Cognitive problems, - Any systemic joint or muscle disease (e.g. fibromyalgia, rheumatoid arthritis), - Serious systemic diseases, - Any neurological disorder (e.g. trigeminal neuralgia), - Pregnancy, breastfeeding status, - Previous treatment for TMJ or orofacial muscle pain

Study Design


Related Conditions & MeSH terms

  • Kinesiophobia
  • Pain
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome

Locations

Country Name City State
Turkey Karadeniz Technical University Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Pain Scale Pain Assessment through study completion, an average of 1 year
Primary Tampa Scale for Kinesiophobia Kinesiophobia Assessment for temporomandibular joint dysfunction through study completion, an average of 1 year
Primary Perceived Stress Scale Stress Assessment through study completion, an average of 1 year
Primary Central sensitization scale Central sensitization Assessment through study completion, an average of 1 year
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