Bruxism, Tooth Wear
Conditions
Brief summary
Investigating the effect of botulinum neurotoxin on the jaw-neck envelope of motion.
Detailed description
Research subjects will be allocated to placebo or botulinum neurotoxin intervention. A control group will not receive any intervention. The intervention will be administered at three separate sessions with 12 weeks in between. Prior to intervention, and 6 months after last intervention the jaw-neck envelope of motion will be studied using 3D optoelectronic recording systems.
Interventions
DRUGBotulinum toxin type A
Botulinum Neurotoxin type A
DRUGPlacebo
Saline solution
Sponsors
Umeå University
Region Västerbotten
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Computerised randomisation, colour coded intervention.
Intervention model description
Double blinded
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Tooth wear into dentin.
Exclusion criteria
* No temporomandibular pathology. * No drugs affecting the central nervous system. * No conditions affecting muscles or central nervous system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of range of motion | Baseline and 6 months after last intervention. Measurements compared to baseline values. | Measured on a cartesian plane in millimeters. |
| Change of envelope of motion | Baseline and 6 months after last intervention. Measurements compared to baseline values. | Volume of envelope of motion measured in cubic millimeters. |
| Change of length in chewing cycles | Baseline and 6 months after last intervention. Measurements compared to baseline values. | Repetitive chewing cycles, measured in milliseconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of muscle thickness | Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values. | Masseter muscle thickness measured through ultrasonography |
| Change of maximal voluntary bite force | Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values. | Measured through a strain gauge meter |
| Tooth wear, change of hard tissue mass | Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values. | Intraoral scanning. Tooth wear measured in cubic millimeters. |
Countries
Sweden
Contacts
Primary ContactMartin Ågren, MScDS
Outcome results
None listed