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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05604729
Other study ID # BoNT A - Morphology
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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