Bruxism Clinical Trial
Official title:
The Effect on Envelope of Motion in Asymptomatic Bruxers - A Double Blinded Study
Investigating the effect of botulinum neurotoxin on the jaw-neck envelope of motion.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Norrlands universitetssjukhus | Umeå | Västerbotten |
Lead Sponsor | Collaborator |
---|---|
Region Västerbotten | Umeå University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of range of motion | Measured on a cartesian plane in millimeters. | Baseline and 6 months after last intervention. Measurements compared to baseline values. | |
Primary | Change of envelope of motion | Volume of envelope of motion measured in cubic millimeters. | Baseline and 6 months after last intervention. Measurements compared to baseline values. | |
Primary | Change of length in chewing cycles | Repetitive chewing cycles, measured in milliseconds. | Baseline and 6 months after last intervention. Measurements compared to baseline values. | |
Secondary | Change of muscle thickness | Masseter muscle thickness measured through ultrasonography | Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values. | |
Secondary | Change of maximal voluntary bite force | Measured through a strain gauge meter | Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values. | |
Secondary | Tooth wear, change of hard tissue mass | Intraoral scanning. Tooth wear measured in cubic millimeters. | Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values. |
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