An interventional study of Botulinum toxin type A and Placebo in Tooth Wear and Bruxism, sponsored by Region Västerbotten. Recruiting at 1 site in Sweden. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Region Västerbotten · Not applicable, Interventional, and Treatment
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.
62 studies on the registry are indexed under Tooth Wear; 12 are open to participants now.
This study's planned enrollment of 60 is above the median of 49 across 41 interventional studies indexed under Tooth Wear.
Browse Tooth Wear studies →Region Västerbotten is the lead sponsor of 15 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Botulinum neurotoxin, 25 units (U) into each masseter at three sessions.
Drug: Botulinum toxin type A
Saline solution
Drug: Placebo
Saline solution, no tooth wear
Drug: Placebo
Botulinum Neurotoxin type A
Also known as: Xeomin
Saline solution
Also known as: Isotonic solution
Change 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.
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Botulinum toxin type A
Region Västerbotten