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Sponsor study identifier
observational
40
1 country
1
Study Start
May 3, 2021
Actual (reported)Primary Completion
December 14, 2023
Actual (reported)Study Completion
December 14, 2023
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 14, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 3, 2021
Actual (reported)April 26, 2022
Actual (reported)May 2, 2022
Actual (reported)December 14, 2023
Actual (reported)December 14, 2023
Actual (reported)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
Maximum molar bite force
basline
Oral related quality of life
baseline
Oral and dental health
Basline
Nordic Orofacial Test - Screening
Basline
Patients at the Department of Neurology at Bispebjerg Hospital.
University of Copenhagen
Copenhagen, 2200, Denmark
Baram S, Thomsen CE, Ozhayat EB, Karlsborg M, Bakke M. Orofacial function and temporomandibular disorders in Parkinson's Disease: a case-controlled study. BMC Oral Health. 2023 Jun 12;23(1):381. doi: 10.1186/s12903-023-03051-6.
Saliva and tongue plaque
40 participants (actual enrollment reported by the registry).
First Submitted
April 26, 2022
First Posted
May 2, 2022
Study Start
May 3, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 14, 2023
Actual (reported)Study Completion
December 14, 2023
Actual (reported)Last Updated
May 8, 2024
Record last verified: 2024-05
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Source: ClinicalTrials.gov.
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