Clinical trial NCT05356845: Oral Health, Orofacial Function and Oral Health Care in Patients With Parkinson's Disease
Official title: Oral Health, Orofacial Function and Oral Health Care in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinsonian Disorders
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2022-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at the Department of Neurology at Bispebjerg Hospital.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

- 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.

Primary outcomes:
measure: Electromyographic analysis
timeFrame: Basline
Secondary outcomes:
measure: Maximum molar bite force
timeFrame: basline
measure: Oral related quality of life
timeFrame: baseline
measure: Oral and dental health
timeFrame: Basline
measure: Nordic Orofacial Test - Screening
timeFrame: Basline
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
References: