The Effect on Envelope of Motion in Asymptomatic Bruxers

Bruxism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05604729
• Other study ID #: BoNT A - Morphology
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Region Västerbotten
• Contact: Martin Ågren, MScDS
• Phone: +46907850000
• Email: martin.agren[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigating the effect of botulinum neurotoxin on the jaw-neck envelope of motion.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bruxism
• Tooth Wear

Intervention

Drug:
• Botulinum toxin type A
Botulinum Neurotoxin type A
• Placebo
Saline solution

Locations

Country	Name	City	State
Sweden	Norrlands universitetssjukhus	Umeå	Västerbotten

Sponsors (2)

Lead Sponsor	Collaborator
Region Västerbotten	Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

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.