The Effect on Envelope of Motion in Asymptomatic Bruxers

Not Applicable

Recruiting

• Conditions: Tooth Wear; Bruxism
• Interventions: Drug: Placebo; Drug: Botulinum toxin type A

• Registration Number: NCT05604729
• Lead Sponsor: Region Västerbotten

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.

Study Timeline

• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-11-01
• Study First Posted: 2022-11-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03
• Study Start: 2023-09-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Saline solution
Control	Placebo	Saline solution, no tooth wear
BoNT A (botulinum neurotoxin type A)	Botulinum toxin type A	Botulinum neurotoxin, 25 units (U) into each masseter at three sessions.

Primary Outcome Measures

Name	Time	Method
Change of envelope of motion	Baseline and 6 months after last intervention. Measurements compared to baseline values.	Volume of envelope of motion measured in cubic millimeters.
Change of range of motion	Baseline and 6 months after last intervention. Measurements compared to baseline values.	Measured on a cartesian plane in millimeters.
Change of length in chewing cycles	Baseline and 6 months after last intervention. Measurements compared to baseline values.	Repetitive chewing cycles, measured in milliseconds.

Secondary Outcome Measures

Name	Time	Method
Tooth wear, change of hard tissue mass	Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.	Intraoral scanning. Tooth wear measured in cubic millimeters.
Change of muscle thickness	Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.	Masseter muscle thickness measured through ultrasonography
Change of maximal voluntary bite force	Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.	Measured through a strain gauge meter

Trial Locations

Locations (1)

Norrlands universitetssjukhus; 🇸🇪 Umeå, Västerbotten, Sweden