Investigating the effect of botulinum neurotoxin on the jaw-neck envelope of motion.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Botulinum Neurotoxin type A
Saline solution
Norrlands universitetssjukhus
Umeå, Västerbotten County, Sweden
RECRUITINGChange of range of motion
Measured on a cartesian plane in millimeters.
Time frame: Baseline and 6 months after last intervention. Measurements compared to baseline values.
Change of envelope of motion
Volume of envelope of motion measured in cubic millimeters.
Time frame: Baseline and 6 months after last intervention. Measurements compared to baseline values.
Change of length in chewing cycles
Repetitive chewing cycles, measured in milliseconds.
Time frame: Baseline and 6 months after last intervention. Measurements compared to baseline values.
Change of muscle thickness
Masseter muscle thickness measured through ultrasonography
Time frame: Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.
Change of maximal voluntary bite force
Measured through a strain gauge meter
Time frame: Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.
Tooth wear, change of hard tissue mass
Intraoral scanning. Tooth wear measured in cubic millimeters.
Time frame: Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.
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