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

Parkinsonian Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05356845
• Other study ID #: OralHelseParkinson
• Status: Completed
• Start date: May 3, 2021
• Est. completion date: December 14, 2023

Study information

• Verified date: May 2024
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 14, 2023
• Est. primary completion date: December 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinsonian Disorders

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum molar bite force	Measure the maximum molar bite force using a transducer in Newton	basline
Secondary	Oral related quality of life	Oral Health Impact Profile questionnaire with 14 questions regarding disability, pain, discomfort, physical impairment, mental impairment, social impairment and disability. Scale from 0-56	baseline
Secondary	Oral and dental health	Measurment: DMFT. Obtained by dental examination and Panoramic radiograph	Basline
Secondary	Nordic Orofacial Test - Screening	Meaure of The orofacial function on a scale from 0 to 12	Basline