Temporomandibular Dysfunction in Patients With Diabetic Foot Ulcers: What Could Be the Predictors?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Temporomandibular Dysfunction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Temporomandibular Dysfunction
时间窗: baseline
An umbrella term covering pain and dysfunction of the muscles of mastication (the muscles that move the jaw) and the temporomandibular joints (the joints which connect the mandible to the skull). Temporomandibular Dysfunction was assessed using the Mandibular Function Disorder Questionnaire. This valid and reliable scale evaluating mandibular dysfunction consists of two dimensions and 17 questions. The first 11 items form the Functional Capacity dimension, and the next six items form the Nutrition dimension. Each question is scored from '0' (no difficulty) to '4' (very difficult or impossible without assistance). A high total score obtained from the questionnaire indicates a high level of impairment in jaw function.
次要结局
- Pain assessment(baseline)
- Quality of life assessment(baseline)
- Swallowing Disorders(baseline)
研究者
Fatih Enzin
assistant professor
Harran University