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Clinical Trial 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.


Clinical Trial 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 . ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06067022
Study type Observational [Patient Registry]
Source Harran University
Contact
Status Completed
Phase
Start date January 5, 2023
Completion date July 5, 2023

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