The Effect on Envelope of Motion in Asymptomatic Bruxers

NCT05604729 | Unknown

• 1 other identifier: BoNT A - Morphology
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tooth Wear; Bruxism

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change of muscle thickness

  Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.

• Change of maximal voluntary bite force

  Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.

• Tooth wear, change of hard tissue mass

  Baseline and 6 months, 1 year and 2 years after last intervention. Measurements compared to baseline values.

Study Arms (3)

BoNT A (botulinum neurotoxin type A)

EXPERIMENTAL

Botulinum neurotoxin, 25 units (U) into each masseter at three sessions.

Drug: Botulinum toxin type A

Placebo

PLACEBO COMPARATOR

Saline solution

Drug: Placebo

Control

PLACEBO COMPARATOR

Saline solution, no tooth wear

Drug: Placebo

Interventions

Botulinum toxin type A DRUG

Botulinum Neurotoxin type A

Also known as: Xeomin

BoNT A (botulinum neurotoxin type A)

Placebo DRUG

Saline solution

Also known as: Isotonic solution

Control; Placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tooth wear into dentin.

You may not qualify if:

• No temporomandibular pathology.
• No drugs affecting the central nervous system.
• No conditions affecting muscles or central nervous system.

Sponsors & Collaborators

• Region Västerbotten: lead
• Umeå University: collaborator

Study Sites (1)

Norrlands universitetssjukhus

Umeå, Västerbotten County, 90185, Sweden

RECRUITING

MeSH Terms

Conditions

Tooth Wear; Bruxism

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA; Isotonic Solutions

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Solutions; Pharmaceutical Preparations

Study Officials

• Mattias Pettersson, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Ågren, MScDS

CONTACT

+46907850000; martin.agren@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Computerised randomisation, colour coded intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Double blinded

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: November 3, 2022
• Study Start: September 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)