Clinical trial NCT06067022: Temporomandibular Dysfunction in Patients With Diabetic Foot Ulcers
Official title: Temporomandibular Dysfunction in Patients With Diabetic Foot Ulcers: What Could Be the Predictors?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcer
Temporomandibular Disorder
Swallowing Disorder
Keywords: Diabetes Mellitus
Diabetic Foot Ulcer
TMJ
Oral Health
Quality of Life
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The aim of this observational study is to investigate the effects of the type, area and duration of ulceration on jaw pain, mandibular function limitation, TMD and swallowing in individuals with diabetic foot ulcers.The main questions it aims to answer are:

* Does the change in foot structure due to diabetic foot ulcer have an effect on the temporomandibular jointand swalloving?
* What are the determinants of tempomandibular dysfunction in individuals with diabetic foot ulcers?

Participants (both groups) will be evaluated for quality of life, jaw functionality, mandibular dysfunction, oropharyngeal swallowing disorder, pain and diabetes complications.

Detailed description: The study was planned in an observational case-control study design. 84 participants were included. Individuals who signed the Informed Consent Form were included in the study. Individuals aged between 46-80 (min-max) who were diagnosed with type 2 DM and DFU in Harran University Research and Application Hospital Endocrinology Polyclinic were included in the study group, and healthy individuals aged 37-85 (min-max) without a diagnosis of DM were included in the control group. Among the exclusion criteria for all individuals from the study, the Mini-Mental Test score should be below 24, history of psychiatric illness, cancer, neurological problems, congenital anomalies, musculoskeletal problems, having a systemic disease, facial paralysis, undergoing surgery due to spine, abdomen and/or TMJ problem and receiving any treatment related to the spine and TMJ in less than 6 months.

In the clinical evaluation of individuals with DFU about diabetes and ulcers; diabetes duration, HbA1C value, glycemic control adequacy, and peripheral arterial disease were recorded, monofilament test was performed for sensory evaluation. Ulcer type and duration were recorded, and ulcer area was measured. Individuals' quality of life was evaluated with the Ferran Powers Quality of Life Index. In the evaluation of oral health in all participants; burning mouth syndrome, dry mouth sensation, tooth loss, tooth decay, and intraoral lesions were questioned.

Participants' pain reports were evaluated using the Numerical Rating Scale (NRS).

Participants' swallowing disorders were evaluated using the Eating Assessment Tool (EAT-10).

Participants' TMJ disorders were evaluated using the Fonseca Anamnestic Index.

Participants' mandibular dysfunctions were evaluated using the Mandibular Function Disorder Questionnaire .

Eligibility criteria: Inclusion Criteria:

* Being over 18 years old
* Having been diagnosed with Type 2 diabetes for at least 10 years
* Not having a serious musculoskeletal, cardiac, neurological, etc. systemic disorder that may interfere with the research.
* Not having any communication problems

Exclusion Criteria:

* Having a diabetic foot ulcer
* Having a diagnosed psychiatric disease,
* Having had a temporomandibular joint operation,
* Having experienced direct or indirect trauma to the head-neck and spine area,
* Having had previous spine surgery,
* Having any mental problems,
* Having a neuromuscular problem that proves a systemic specific pathological condition such as malignant condition of the spine and/or TMJ, fracture, rheumatoid disease,
* Having had facial paralysis less than 1 year ago,
* Being diagnosed with TMD,
* Having received TMJ-related physical therapy treatment in less than 6 months.

Primary outcomes:
measure: Temporomandibular Dysfunction
timeFrame: baseline
Secondary outcomes:
measure: Quality of life assessment
timeFrame: baseline
measure: Swallowing Disorders
timeFrame: baseline
measure: Pain assessment
timeFrame: baseline
Other outcomes:
Locations:
city: Sanliurfa
country: Turkey
facility: Fatih Enzin
state: Haliliye
Study officials:
affiliation: Harran University
name: Fatih Enzin, asst prof dr
role: PRINCIPAL_INVESTIGATOR
References: