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

Sponsor
University of Copenhagen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05356845
Collaborator
Bispebjerg Hospital (Other)
40
1
17
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Oral Health, Orofacial Function and Oral Health Care in Patients With Parkinson's Disease
    Actual Study Start Date :
    May 3, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Oct 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    PD group

    Control group

    Outcome Measures

    Primary Outcome Measures

    1. Electromyographic analysis [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 Outcome Measures

    1. Maximum molar bite force [basline]

      Measure the maximum molar bite force using a transducer in Newton

    2. Oral related quality of life [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 [Basline]

      Measurment: DMFT. Obtained by dental examination and Panoramic radiograph

    4. Nordic Orofacial Test - Screening [Basline]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Copenhagen Copenhagen Denmark 2200

    Sponsors and Collaborators

    • University of Copenhagen
    • Bispebjerg Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merete Bakke, Professor, University of Copenhagen
    ClinicalTrials.gov Identifier:
    NCT05356845
    Other Study ID Numbers:
    • OralHelseParkinson
    First Posted:
    May 2, 2022
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 10, 2022