Primary Objective: to investigate the prevalence of bruxism and TMD in PD patients through objective measurements.Secondary Objectives: to identify factors associated with the presence of TMD or bruxism in a PD population.
ID
Source
Brief title
Condition
- Muscle disorders
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: the primary study parameters are the presence
of bruxism, and a TMD diagnosis, according to the Diagnostic Criteria for TMD.
Secondary outcome
The following variables will be evaluated: Medication (viz., Levodopa
Equivalent Daily Dose (LEDD)), pain (viz., pain severity), psychosocial
symptoms (viz., depression, apathy, anxiety, psychotic, impulse control,
somatic symptoms), brain function (viz., cognitive function, presynaptic
dopaminergic loss), disease progression (viz., disease stage, disease
severity), sleep (viz., quality of sleep, REM sleep behaviour disorder, OSAS)
and quality of life.
Background summary
Earlier research shows that there might be a connection between Parkinson*s
disease on one hand and teeth grinding, teeth clenching, and jaw joint issues
on the other hand. The symptoms that can arise from these conditions can very
inconvenient for patients. The knowledge from this research can assist dentists
in providing personalized care to patients with Parkinson*s disease who
experience teeth grinding, teeth clenching, and or TMD problems, thereby
contributing to an improved quality of life.
*
Study objective
Primary Objective: to investigate the prevalence of bruxism and TMD in PD
patients through objective measurements.
Secondary Objectives: to identify factors associated with the presence of TMD
or bruxism in a PD population.
Study design
Study design: Observational case-control study design.
Study burden and risks
During an appointment with the neurologist, patients will be informed about the
study. A few days later they will be called by the investigator with the
question if they want to participate. Participants will fill out a research
questionnaire (±30 min) and be examined clinically (±20-60 min). Subsequently,
all eligible patients will be asked to sleep for 5 nights with a one-channel
EMG mobile device (Butler GrindCare®) at home, and to keep a diary for 7 days
during wakefulness, to confirm the diagnosis of bruxism. Clinical examination
will take place at Academic Centre of Dentistry Amsterdam (ACTA) or at
Amsterdam UMC, according to the preferences of the participants. Short-term
risks of the clinical examination include possible mild muscle pain and fatigue
in the masticatory muscles. This will be minimalized through short
intermissions when needed. In addition, in some patients, the gel pad of the
Butler GrindCare® can cause reversible skin irritation. There are no long-term
risks associated with this study. Patients with a pacemaker or Deep Brain
Stimulator (DBS) cannot use the Butler GrindCare® and are excluded for that
part of the study.
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Listed location countries
Age
Inclusion criteria
- Patients who fulfil the clinical diagnostic criteria for PD.
- Adults (>18 years old)
Exclusion criteria
- Children or adolescents (<18 years old)
- Patients with a pacemaker or DBS (only excluded for using Butler GrindCare®
- Montreal Cognitive Assessment (MoCA) score <18
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84981.018.23 |