Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Umeå University | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BoNT A (botulinum neurotoxin type A) | Experimental | Botulinum neurotoxin, 25 units (U) into each masseter at three sessions. |
|
| Placebo | Placebo Comparator | Saline solution |
|
| Control | Placebo Comparator | Saline solution, no tooth wear |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Drug | Botulinum Neurotoxin type A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of range of motion | Measured on a cartesian plane in millimeters. | 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. | Baseline and 6 months after last intervention. Measurements compared to baseline values. |
| Change of length in chewing cycles | Repetitive chewing cycles, measured in milliseconds. | Baseline and 6 months after last intervention. Measurements compared to baseline values. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Change of maximal voluntary bite force |
Not provided
Inclusion Criteria:
• Tooth wear into dentin.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Ågren, MScDS | Contact | +46907850000 | martin.agren@umu.se |
| Name | Affiliation | Role |
|---|---|---|
| Mattias Pettersson, PhD | Umeå University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norrlands universitetssjukhus | Recruiting | Umeå | Västerbotten County | 90185 | Sweden |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D057085 | Tooth Wear |
| D002012 | Bruxism |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D006184 | Habits |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C545476 | incobotulinumtoxinA |
| D007552 | Isotonic Solutions |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Double blinded
Not provided
Not provided
Computerised randomisation, colour coded intervention.
| Placebo | Drug | Saline solution |
|
|
Measured through a strain gauge meter
| 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. | Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values. |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |