Skip to main content
OpenTrials
Completed

NCT Number: NCT05356845

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Copenhagen

Copenhagen, 2200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Electromyographic analysis

    Time frame: 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.

Secondary outcomes

  1. Maximum molar bite force

    Time frame: basline

    Measure the maximum molar bite force using a transducer in Newton

  2. Oral related quality of life

    Time frame: baseline

    Oral Health Impact Profile questionnaire with 14 questions regarding disability, pain, discomfort, physical impairment, mental impairment, social impairment and disability. Scale from 0-56

  3. Oral and dental health

    Time frame: Basline

    Measurment: DMFT. Obtained by dental examination and Panoramic radiograph

  4. Nordic Orofacial Test - Screening

    Time frame: Basline

    Meaure of The orofacial function on a scale from 0 to 12

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Bispebjerg Hospital

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 2, 2022
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.