The objective of this pilot study is to provide further insights about the neural correlates of teeth clenching (during awake state) and tmd pain in bruxers and non-bruxers or more specific:The primary objective of the study is to provide further…
ID
Source
Brief title
Condition
- Other condition
- Movement disorders (incl parkinsonism)
Synonym
Health condition
orale bewegingsstoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a. the measure (qualitative/quantitative) of brain activity during teeth
clenching
b. the measure of brain activity during tmd pain
Endpoints will be if there is no brain activity at all or the measurements are
too weak so that a follow up study will not be indicated anymore; if the
measurements of brain activity are strong enough in case of teeth clenching but
not in the case of tmd pain, the follow up study will be executed in a modified
form.
Secondary outcome
not applicable
Background summary
This pilot study will function as a baseline measurement of an intervention
study, investigating changes in brain activity during awake state in the group
of awake bruxers with tmd pain by application of cognitive behaviour therapy
and if/whether behaviour change correlates with the change in frequency of
tooth contact and tmd pain.
Cognitive behaviour therapy (CBT) currently is an appropriate application in
the management of bruxism. The intervention therapy, which is specific focused
on awake bruxism, is based on the hypothesis that this behaviour (i.e. teeth
clenching) shows neural correlates in human brains. To improve the objectivism
of behavioural change, we want to deploy MRI. Before we can start with the
intervention study, we want to investigate by this pilot study whether the
neural correlates are strong enough to use in the intervention study. Apart
from already in existing studies applied functional MRI, we also want applying
*resting-state* MRI in this pilot study. Till now there are no studies
publicised investigating behaviour change in bruxism by MRI and the neural
correlates associated with it.
Study objective
The objective of this pilot study is to provide further insights about the
neural correlates of teeth clenching (during awake state) and tmd pain in
bruxers and non-bruxers or more specific:
The primary objective of the study is to provide further insights about the
neural correlates (i.e. the extent of brain activity) of teeth clenching
(during awake state) in bruxers and non-bruxers.
The secondary objective of the study is to provide further insights about the
neural correlates (i.e. the extent of brain activity) of tmd pain and to
investigate the difference in brain activity between subjects (bruxers) with
tmd pain and subjects (non-bruxers) without tmd pain.
Study design
This is an exploring, observing and inventorying pilot study in which MRI
measurements of brain activity in relevant brain structures are collected.
All participants will undergo MRI measurements in which data are collected
concerning relevant brain structures (motor cortex, somatosensory cortex),
executive brain function, intrinsic organisation of brain function (functional
connectivity) and white matter integrity.
Study burden and risks
not applicable
P.Debyelaan 25
Maastricht 6229 HX
NL
P.Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
bruxers with tmd pain
non-bruxers without tmd pain
beside this criteria subjects needs to meet the following criteria: 18 years or older; mentally competent; in a good physical and mental health.
Exclusion criteria
bruxers without tmd pain
non-bruxers with tmd pain
beside this criteria subjects who meets any of the following criteria will be excluded: persons with a full denture in upper and or lower jaw; persons with pain elsewhere in the body; persons who meets one of the criteria below:
a history of head or brain operations,
in case of an implanted electronic device (i.g. pacemaker),
in case of an subcutaneous insulin pump,
in case of claustrophobia,
in case of cardiac arrhythmia,
in case of pregnancy,
in case of, except tooth fillings and dental crowns, other metal particles embedded in the body such as: implants, blood vessel clips, metal particles in the eye, an IUD, metal wires, other kinds of metal objects.
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 | NL56974.068.16 |