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

NCT05356845 | Completed

• 1 other identifier: OralHelseParkinson
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinsonian Disorders

Outcome Measures

Primary Outcomes (1)

• Electromyographic analysis

  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.

  Basline

Secondary Outcomes (4)

• Maximum molar bite force

  basline

• Oral related quality of life

  baseline

• Oral and dental health

  Basline

• Nordic Orofacial Test - Screening

  Basline

Study Arms (2)

PD group

Control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at the Department of Neurology at Bispebjerg Hospital.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• Bispebjerg Hospital: collaborator

Study Sites (1)

University of Copenhagen

Copenhagen, 2200, Denmark

Location

Related Publications (1)

• Baram S, Thomsen CE, Ozhayat EB, Karlsborg M, Bakke M. Orofacial function and temporomandibular disorders in Parkinson's Disease: a case-controlled study. BMC Oral Health. 2023 Jun 12;23(1):381. doi: 10.1186/s12903-023-03051-6.

  PMID: 37308874 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and tongue plaque

MeSH Terms

Conditions

Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: May 3, 2021
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)