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The Effect on Envelope of Motion in Asymptomatic Bruxers

Sponsor
Region Västerbotten (Other)
Overall Status
Recruiting
CT.gov ID
NCT05604729
Collaborator
Umeå University (Other)
60
Enrollment
1
Location
3
Arms
34
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Botulinum toxin type A
  • Drug: Placebo
 N/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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double blindedDouble blinded
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Computerised randomisation, colour coded intervention.
Primary Purpose:
Treatment
Official Title:
The Effect on Envelope of Motion in Asymptomatic Bruxers - A Double Blinded Study
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of range of motion [Baseline and 6 months after last intervention. Measurements compared to baseline values.]

      Measured on a cartesian plane in millimeters.

    2. 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.

    3. 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

    1. 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

    2. 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

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Norrlands universitetssjukhus Umeå Västerbotten Sweden 90185

    Sponsors and Collaborators

    • Region Västerbotten
    • Umeå University

    Investigators

    • Principal Investigator: Mattias Pettersson, PhD, Umeå University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Region Västerbotten
    ClinicalTrials.gov Identifier:
    NCT05604729
    Other Study ID Numbers:
    • BoNT A - Morphology
    First Posted:
    Nov 3, 2022
    Last Update Posted:
    Nov 3, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Bruxism
    Tooth Wear
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Nov 3, 2022