The Effect on Envelope of Motion in Asymptomatic Bruxers
Primary Purpose
Tooth Wear, Bruxism
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Botulinum toxin type A
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Wear
Eligibility Criteria
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.
Sites / Locations
- Norrlands universitetssjukhusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
BoNT A (botulinum neurotoxin type A)
Placebo
Control
Arm Description
Botulinum neurotoxin, 25 units (U) into each masseter at three sessions.
Saline solution
Saline solution, no tooth wear
Outcomes
Primary Outcome Measures
Change of range of motion
Measured on a cartesian plane in millimeters.
Change of envelope of motion
Volume of envelope of motion measured in cubic millimeters.
Change of length in chewing cycles
Repetitive chewing cycles, measured in milliseconds.
Secondary Outcome Measures
Change of muscle thickness
Masseter muscle thickness measured through ultrasonography
Change of maximal voluntary bite force
Measured through a strain gauge meter
Tooth wear, change of hard tissue mass
Intraoral scanning. Tooth wear measured in cubic millimeters.
Full Information
NCT ID
NCT05604729
First Posted
April 1, 2022
Last Updated
May 2, 2023
Sponsor
Region Västerbotten
Collaborators
Umeå University
1. Study Identification
Unique Protocol Identification Number
NCT05604729
Brief Title
The Effect on Envelope of Motion in Asymptomatic Bruxers
Official Title
The Effect on Envelope of Motion in Asymptomatic Bruxers - A Double Blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Västerbotten
Collaborators
Umeå University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigating the effect of botulinum neurotoxin on the jaw-neck envelope of motion.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Wear, Bruxism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Computerised randomisation, colour coded intervention.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BoNT A (botulinum neurotoxin type A)
Arm Type
Experimental
Arm Description
Botulinum neurotoxin, 25 units (U) into each masseter at three sessions.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline solution
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Saline solution, no tooth wear
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
Xeomin
Intervention Description
Botulinum Neurotoxin type A
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Isotonic solution
Intervention Description
Saline solution
Primary Outcome Measure Information:
Title
Change of range of motion
Description
Measured on a cartesian plane in millimeters.
Time Frame
Baseline and 6 months after last intervention. Measurements compared to baseline values.
Title
Change of envelope of motion
Description
Volume of envelope of motion measured in cubic millimeters.
Time Frame
Baseline and 6 months after last intervention. Measurements compared to baseline values.
Title
Change of length in chewing cycles
Description
Repetitive chewing cycles, measured in milliseconds.
Time Frame
Baseline and 6 months after last intervention. Measurements compared to baseline values.
Secondary Outcome Measure Information:
Title
Change of muscle thickness
Description
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.
Title
Change of maximal voluntary bite force
Description
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.
Title
Tooth wear, change of hard tissue mass
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Ågren, MScDS
Phone
+46907850000
Email
martin.agren@umu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mattias Pettersson, PhD
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norrlands universitetssjukhus
City
Umeå
State/Province
Västerbotten
ZIP/Postal Code
90185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Ågren, MScDS
Email
martin.agren@regionvasterbotten.se
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect on Envelope of Motion in Asymptomatic Bruxers
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