NCT05356845Completed
Oral Health, Orofacial Function and Oral Health Care in Patients With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 40 (actual)
- First submitted
- 26 Apr 2022
- Start date
- 3 May 2021
- Primary completion date
- 14 Dec 2023
- Lead sponsor
- University of Copenhagen
- Diseases
- Parkinson disease
- NCT number
- NCT05356845
What you commit to
- Study type: Observational
- Participants enrolled: 40
- From 3 May 2021 to the primary completion date, 14 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Copenhagen Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.