The Effect on Envelope of Motion in Asymptomatic Bruxers

Study Overview
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Brief Summary
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Investigating the effect of botulinum neurotoxin on the jaw-neck envelope of motion.

Detailed Description
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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.

Official Title
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The Effect on Envelope of Motion in Asymptomatic Bruxers - A Double Blinded Study

Conditions
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Tooth Wear, Bruxism

Intervention / Treatment
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* Drug: Botulinum toxin type A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BoNT A (botulinum neurotoxin type A)<br>Botulinum neurotoxin, 25 units (U) into each masseter at three sessions. | Drug: Botulinum toxin type A<br>* Botulinum Neurotoxin type A<br>* Other names: Xeomin;|
| Placebo Comparator: Placebo<br>Saline solution | Drug: Placebo<br>* Saline solution<br>* Other names: Isotonic solution;|
| Placebo Comparator: Control<br>Saline solution, no tooth wear | Drug: Placebo<br>* Saline solution<br>* Other names: Isotonic solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |