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临床试验/NCT05356845
NCT05356845已完成不适用

Oral Health, Orofacial Function and Oral Health Care in Patients With Parkinson's Disease

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Electromyographic analysis

研究概览

简要总结

Introduction: Problems with oral health (dental and oral diseases) as well as orofacial function (jaw opening, chewing and salivation problems) are significant challenges for many people with Parkinson's disease (PD). These challenges may be painful, disabling, and cause great psychosocial strain and negatively affect quality of life. Furthermore, they may contribute to an unsecure and unhealthy aging, because eating and enjoyment of food is important for both the physical and psychological wellbeing for elderly and chronically ill patients. It seems that patients with PD often find it difficult to maintain adequate oral hygiene and fail to visit the dentist, which in the end contributes to tooth loss, eating problems, poorer nutrition, social challenges and reduced quality of life.

To be able to plan interventions on a larger scale more detailed knowledge and mapping is necessary on the extent of various manifestations of PD in the orofacial area, the affect on the patients and their quality of life, and how the disease develops in the orofacial area for the patient group over time. The study will clarify the challenges and problems that patients with PD have due to their disease in terms of dental and oral health and function of mouth and jaws. Such information is important both for single patients with respect to prevention and intervention and for development of community health strategies.

Purpose

  • to investigate specific orofacial, non-motor and motor symptoms and functions as well as the oral microbiome in patients with PD compared to a control group.
  • to examine the quality of life related to oral health in the abovementioned groups.
  • to provide information on the orofacial problems in PD for the benefit of single patients with respect to prevention and intervention and for development of community health strategies.

Hypotheses: It is expected that

  • patients with PD have more orofacial functional problems and poorer oral health than a control group without PD, and patients with late PD have more orofacial functional problems and poorer oral health than patients with early PD.
  • patients with PD have an altered oral microbiome compared to a control group without PD, which possibly may assist in the staging of PD.
  • patients with PD have poorer oral health related quality of life and home dental care than a control group without PD.

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
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All participants must be able to understand the participant information and must be able to collaborate in connection with the study. Must be able to transport himself to and from the Dental School and must be able to sit upright in a dental chair during the examination.
  • Inclusion criteria for patients with PD: Participants must be in stable and well-medicated treatment and affiliated with the Department of Neurology at Bispebjerg Hospital (outpatient clinic N30).
  • Inclusion criteria for controls: Persons with comparable age and gender distribution without PD diagnosis.

排除标准

  • For all participants: Participants with the diagnosis Sjogren's syndrome, implanted electronic devices in the body (pacemaker, DBS and the like) and / or participants who receive or have received radiation in the head / neck region in connection with cancer treatment.

结局指标

主要结局

Electromyographic analysis

时间窗: Basline

Measurment: micro volt. Electromyographic measurement of the resting, chewing, swallowing, jaw opening and teeth clenching of the temporalis muscle, the digastric muscle and the masseter bilaterally. Detected with bipolar surface electrodes during 10 s resting and posture activity, chewing 10 g apple, swallowing 2 mL water, maximal jaw opening and teeth clenching.

次要结局

  • Nordic Orofacial Test - Screening(Basline)
  • Maximum molar bite force(basline)
  • Oral and dental health(Basline)
  • Oral related quality of life(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Merete Bakke

Professor

University of Copenhagen

研究点 (1)

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