Back to resultsMuscle Weakness Duration After Single Botulinum Toxin Injection in Masseter
Primary Purpose
Bite Force, Botulinum Toxins, Type A
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Bite Force
Eligibility Criteria
Inclusion Criteria:
Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume.
Exclusion Criteria:
Conditions or drugs affecting the central nervous system.
Sites / Locations
- Norrlands universitetssjukhus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Intervention with single botulinum neurotoxin injection into masseter.
No intervention
Outcomes
Primary Outcome Measures
Change of bite force
Maximum voluntary bite force measured in Newtons at baseline, and change of bite force compared to baseline.
Secondary Outcome Measures
Full Information
NCT ID
NCT05309564
First Posted
March 14, 2022
Last Updated
May 2, 2023
Sponsor
Region Västerbotten
Collaborators
Umeå University, Mahidol University
1. Study Identification
Unique Protocol Identification Number
NCT05309564
Brief Title
Muscle Weakness Duration After Single Botulinum Toxin Injection in Masseter
Official Title
Muscle Weakness Duration Post-injection of a Single Dose of Botulinum Toxin in the Masseter Muscle Bilaterally: a One-year Non-randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
January 10, 2022 (Actual)
Study Completion Date
March 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Västerbotten
Collaborators
Umeå University, Mahidol University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to evaluate the duration of a reduced maximal voluntary bite force after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz Pharma GmbH & Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected into the masseter muscles bilaterally (to a total of 50 units).
Detailed Description
This study aimed to evaluate the duration of a reduced maximal voluntary bite force (MVBF) after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz Pharma GmbH & Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected into the masseter muscles bilaterally (to a total of 50 units). A control group did not receive any intervention. MVBF was measured in Newtons using a strain gauge meter at the incisors and first molars. The intervention group was comprised of individuals seeking aesthetic treatment for masseter reduction (n = 20), and the control group (n = 12) comprised of volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bite Force, Botulinum Toxins, Type A
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention with single botulinum neurotoxin injection into masseter.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
Xeomin
Intervention Description
Single intervention
Primary Outcome Measure Information:
Title
Change of bite force
Description
Maximum voluntary bite force measured in Newtons at baseline, and change of bite force compared to baseline.
Time Frame
Baseline, 4 weeks, 3 months, 6 months, 12 months.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume.
Exclusion Criteria:
Conditions or drugs affecting the central nervous system.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
2020-03517 Pettersson, PhD
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norrlands universitetssjukhus
City
Umeå
State/Province
Västerbotten
ZIP/Postal Code
90185
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Muscle Weakness Duration After Single Botulinum Toxin Injection in Masseter
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