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临床试验/NCT06034769
NCT06034769已完成不适用

Oral Health, Temporomandibular Dysfunction and Oropharyngeal Dysphagia in Bipolar Patients

Bandırma Onyedi Eylül University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年2月1日最近更新:
适应症

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
Eating Assessment Tool (EAT-10)

研究概览

简要总结

The assessment of oral health, jaw health and related problems in bipolar patients is important to provide a holistic approach to patients in terms of physical, mental and psychosocial aspects and to improve quality of life. In this study, oral health, temporomandibular dysfunction (TMD) and oropharyngeal dysphagia (OD) were investigated in patients with Bipolar Disorder (BD).

详细描述

During the remission period, 70 individuals aged 20-60 years with BD were divided into two groups according to the duration of diagnosis as under ten years (Group 1=33) and over ten years (Group 2=37). Oral and dental health-related quality of life was assessed with the Oral Health Impact Profile-14 (OHIP-14), TMJ pain was assessed with the Numeric Pain Scale (NPS), the presence of TMJ discomfort was assessed with the Fonseca Anamnestic Questionnaire (FAQ), chewing functionality was assessed with the Jaw Function Limitation Scale-8 (JFLS-8), and oropharyngeal dysphagia was assessed with the Eating Assessment Tool (EAT-10).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 20 and 60 years of age who volunteered to participate in the study and signed the informed consent form,
  • diagnosed with BD at the outpatient department of Bakırkoy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital,
  • in remission for at least 3 months,
  • had a history of regular lithium use for at least 1 year in any phase of the disease were included in the study.

排除标准

  • being in a manic or depressive episode (Young Mania Rating Scale score greater than 7, Hamilton Depression Rating Scale score greater than 7)
  • history of comorbid psychiatric illness,
  • alcohol and substance use disorder,
  • cancer, neurological problems, congenital anomalies, musculoskeletal problems, systemic illness,
  • facial paralysis,
  • spinal, abdominal and/or TMJ surgery,
  • and having received any spinal or TMJ treatment in less than 6 months.

结局指标

主要结局

Eating Assessment Tool (EAT-10)

时间窗: February 2023- July 2023

This scale, which assesses the symptoms and severity of oropharyngeal swallowing disorder and has been shown to be valid and reliable, consists of 10 questions. A total score of 3 and above on the scale, indicates the presence of a swallowing problem.

Jaw Functional Limitation Scale-8 (JFLS-8)

时间窗: February 2023- July 2023

This scale, which has demonstrated validity and reliability, provides an assessment of chewing functionality during various activities of the jaw and consists of 8 questions. On this scale, which ranges from 0-80, a high score indicates limited chewing functionality.

Oral Health Impact Profile-14 (OHIP-14)

时间窗: February 2023- July 2023

This scale, which has been shown to be valid and reliable in measuring oral and dental health-related quality of life, consists of 14 questions in 7 dimensions. Each question is scored from 0 (never) to 4 (always). The scale ranges from 0 to 56, with high scores indicating poor quality of life.

Fonseca Anamnestic Questionnaire (FAQ)

时间窗: February 2023- July 2023

This scale, which has been shown to be valid and reliable as a TMD assessment tool, consists of 10 questions. A score of 25 or more on the scale indicates the presence of TMD.

Numerical Pain Scale (NPS)

时间窗: February 2023- July 2023

This simple, valid and reliable method, often used to measure pain intensity in the clinic, asks the participant to mark a number on a 10 cm scale with numbers ranging from '0' (no pain) to '10' (unbearable pain) for the pain felt in the TMJ region

次要结局

未报告次要终点

研究者

发起方
Bandırma Onyedi Eylül University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hazel Çelik Güzel

Assist. Prof. Dr

Bandırma Onyedi Eylül University

研究点 (1)

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