The Effect of Diabetic Peripheral Neuropathy Symptoms on Temporomandibular Joint Functionality in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Maximum pain-free mouth opening
研究概览
简要总结
The aim of this observational case-control study was to investigate the effect of diabetic peripheral neuropathy symptoms on temporomandibular joint functionality in patients with type 2 diabetes.
详细描述
The number of participants planned to be included in the study was decided with the G-Power programme. While calculating the number of individuals to be included in the study, it was calculated that the sample size to obtain an effect size of 0.6 for the purpose of evaluation within the 95% confidence interval in a way to provide 80% study power at 5% Type 1 and 20% Type 2 error limits should be 74 (n=37) individuals. This study included 70 individuals (DM study group=40 individuals, control group=30 individuals).
Peripheral neuropathy symptoms of all participants were evaluated with the Michigan Neuropathy Screening Test. In the evaluation of TMJ functionality, the presence of pain, maximum pain-free mouth opening, mandibular dysfunction and dysfunction were assessed with the help of scales. Duration of diabetes mellitus was recorded and quality of life was evaluated with Ferran Powers Quality of Life Index.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 48 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals diagnosed with type 2 DM
排除标准
- •Having diabetic foot ulcer,
- •Mini Mental Test score below 24,
- •History of psychiatric illness, cancer, neurological problems, congenital anomalies, musculoskeletal problems, systemic disease, facial paralysis, surgical operation related to spine, abdomen and/or TMJ problem
- •Receiving any treatment related to spine and TMJ in less than 6 months
结局指标
主要结局
Maximum pain-free mouth opening
时间窗: May 2023- November 2023
The maximum pain-free mouth opening was recorded using a 15 cm ruler
Michigan Neuropathy Screening Instrument
时间窗: May 2023- November 2023
The symptom questionnaire includes 15 questions about the legs and feet. Physical examination includes assessment of the appearance of the feet, Achilles reflex, thumb vibration and monofilament tests. High score indicates increased neuropathy
Ferrans&Powers Quality of Life Index Diabetes Version
时间窗: May 2023- November 2023
The Quality of Life Assessment Index consists of two parts and a total of 68 items. A high score indicates a good quality of life
Numeric Pain Scale
时间窗: May 2023- November 2023
The participant is asked to mark a number on a 10 cm scale, on which numbers are shown in the range of "0" (no pain) to "10" (unbearable pain) for the pain. High score indicates increased pain
Mandibular Function Disorder Questionnaire
时间窗: May 2023- November 2023
This scale evaluating mandibular dysfunction consists of two dimensions and 17 questions.A high total score obtained from the questionnaire indicates a high level of impairment in jaw function.
Fonseca Anamnestic Index
时间窗: May 2023- November 2023
This scale includes 10 questions. The presence of TMD is accepted in those with a score of 25. High score indicates increased dysfunction.
次要结局
未报告次要终点
研究者
Hazel Çelik Güzel
Assist. Prof. Dr
Bandırma Onyedi Eylül University