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CompletedNCT05356845Updated May 8, 2024

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

An observational study in Parkinsonian Disorders, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University of Copenhagen · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years to 100 Years
Sex
All
01

Study 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.
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Conditions studied

  • Parkinsonian Disorders
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 40 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients at the Department of Neurology at Bispebjerg Hospital.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
40 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • PD group
  • Control group
06

What researchers measure

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.

    Time frame: Basline

Secondary outcomes

  1. Maximum molar bite force

    Measure the maximum molar bite force using a transducer in Newton

    Time frame: basline

  2. 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

    Time frame: baseline

  3. Oral and dental health

    Measurment: DMFT. Obtained by dental examination and Panoramic radiograph

    Time frame: Basline

  4. Nordic Orofacial Test - Screening

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

    Time frame: Basline

07

Study locations

1 site
  • University of Copenhagen
    Copenhagen, 2200, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05356845
Lead sponsor
University of Copenhagen
Collaborators
Bispebjerg Hospital
Responsible party
Merete Bakke (Professor, University of Copenhagen) — Principal investigator
First posted
May 2, 2022
Start date
May 3, 2021
Primary completion
Dec 14, 2023
Completion
Dec 14, 2023
Last update
May 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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