(A) Determine the influence of anger and frustration on self-reported bruxism.(B) Validation of a new ambulant electromyographic (EMG) diagnostic device for bruxism (TeleBrux).(C) Determine the additional value of peripheral modulation with…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(A) Self-reported awake and sleepbruxism, anger and frustration.
(B, C) Established criteria for sleepbruxism (bruxism episodes per hour,
bruxism bursts per episode/hour, episodes with sounds).
Secondary outcome
(A) Use of alcohol, smoking, anxiety, stress, sleep quality.
(B) Subjective experiences with TeleBrux, sleep quality.
(C) Experiences with sleep quality, bruxism and stretching, range of motion of
the jaw, pain threshold and pain tolerance, pain, bite force, mandibular
function.
Background summary
Bruxism is a repetitive jaw muscle activity characterized by clenching and/or
grinding of the teeth and has two distinct manifestations: it can occur during
sleep (sleepbruxism, SB) or during wakefulness (awake bruxism). Bruxism can
cause dental problems such as tooth wear and pain in the jaw muscles and
joints. Psychosocial factors such as emotions are associated with bruxism.
Studies on the emotions anger and frustration as etiological factors for SB are
scarce and contradictory results. For the determination of SB is
polysomnography (PSG) in a sleep laboratory, described as the gold standard.
There is, however, both for clinical and research purposes, a strong need for
ambulatory diagnostic devices which are user-friendly. In the treatment of SB
is the standard care counseling and sleep hygiene. The question is whether
bruxism can be modulated peripherally, for example, by stretching the jaw
muscles.
Study objective
(A) Determine the influence of anger and frustration on self-reported bruxism.
(B) Validation of a new ambulant electromyographic (EMG) diagnostic device for
bruxism (TeleBrux).
(C) Determine the additional value of peripheral modulation with stretching of
the muscles of the jaw in the management of bruxism in comparison with standard
care alone.
Study design
(A, B) Prospective cohortstudy.
(C) Randomised controlled clinical trial.
Intervention
(A, B) No intervention.
(C) Control group receives standard care (counseling and sleep hygiene), and
intervention group receives standard care and stretching exercises.
Study burden and risks
The studies do not bring any risks for the participants. The burden is minimal.
In study A the burden is a minimal time investment for filling in the
questionnaires. In studie B and C the burden also consists of discomfort by
application and wearing the diagnostic devices. In study C the participants can
experience discomfort by the stretching exercises.
Philips van Leydenlaan 25
Nijmegen 6525EX
NL
Philips van Leydenlaan 25
Nijmegen 6525EX
NL
Listed location countries
Age
Inclusion criteria
(A) Study on etiology
- Age: adults of >18 years
- Is aware of his/her clenching and/or grinding and/or his/her bed partner notice this;(B) Study on diagnostics
- Age: 20-45 years
- Awareness of presence or absence of clenching and/or grinding;(C) Study on management
- Age: 20-45 years
- Clear signs (partner/intraoral) and/or the subject is aware of his/her clenching and/or grinding
Exclusion criteria
(A) Study on etiology
- Presence of neurological disorders, neoplasms, psychiatric diseases
- Removable intraoral device, such as a full prothesis, frame prothesis or plate prothesis
- Treatment for TMD or bruxism
- Orthodontic treatment at the moment
- Use of medication which can influence the clenching and grinding
- Use of soft/harddrugs
- Toothache
- Dental treatment in the next 6 months, with plans for crowns, bridges, prothesis of more than one filling;(B) Study on diagnostics, and (C) Study on management
- Waking up with a pain complaint in the orofacial region
- Absence of natural teeth in the front, the presence of loose and/or painful elements
- Dislocated temporomandibular joint
- Limited mouth opening
- Excessive use of alcohol
- Use of soft/harddrugs
- Use of medication affecting sleep or motor behavior (psychotropic drugs, such as amphetamines, benzodiazepines, L-dopa, antipsychotics, tricyclic antidepressants, SSRI)
- Neurological and neuromuscular disorders with effects on motor skills (such as epilepsy, Parkinson's disease, SMA, Duchenne muscular dystrophy)
- Psychiatric disorders (such as schizophrenia)
- Severe systemic diseases (such as MS).
Design
Recruitment
Medical products/devices used
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 | NL46301.091.13 |