The Effect on Envelope of Motion in Asymptomatic Bruxers

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

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

Study Overview

• Status: Recruiting
• Conditions: Bruxism; Tooth Wear
• Intervention / Treatment: Drug: Placebo; Drug: Botulinum toxin type A

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Ågren, MScDS; Phone Number: +46907850000; Email: martin.agren@umu.se

Study Locations

• Sweden
  • Västerbotten
    • Umeå, Västerbotten, Sweden, 90185
      • Recruiting
      • Norrlands Universitetssjukhus
      • Contact: Martin Ågren, MScDS; Email: martin.agren@regionvasterbotten.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Region Västerbotten
• Collaborators: Umeå University
• Investigators: Principal Investigator: Mattias Pettersson, PhD, Umeå University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Bruxism; Tooth Wear; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: BoNT A - Morphology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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