- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Sara Baram, DDS
- Phone Number: 0045 30255350
- Email: sarb@sund.ku.dk
Study Locations
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-
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Copenhagen, Denmark, 2200
- Recruiting
- University of Copenhagen
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Contact:
- Sara Baram, DDS
- Phone Number: 30255350
- Email: sarb@sund.ku.dk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Control group
|
PD group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Basline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum molar bite force
Time Frame: basline
|
Measure the maximum molar bite force using a transducer in Newton
|
basline
|
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
|
baseline
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Oral and dental health
Time Frame: Basline
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Measurment: DMFT.
Obtained by dental examination and Panoramic radiograph
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Basline
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Nordic Orofacial Test - Screening
Time Frame: Basline
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Meaure of The orofacial function on a scale from 0 to 12
|
Basline
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OralHelseParkinson
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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