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Muscle Weakness Duration After Single Botulinum Toxin Injection in Masseter

Muscle Weakness Duration Post-injection of a Single Dose of Botulinum Toxin in the Masseter Muscle Bilaterally: a One-year Non-randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05309564
Enrollment
32
Registered
2022-04-04
Start date
2020-03-01
Completion date
2022-03-14
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bite Force, Botulinum Toxins, Type A

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.

Interventions

DRUGBotulinum toxin type A

Single intervention

Sponsors

Umeå University
CollaboratorOTHER
Mahidol University
CollaboratorOTHER
Region Västerbotten
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume.

Exclusion criteria

Conditions or drugs affecting the central nervous system.

Design outcomes

Primary

MeasureTime frameDescription
Change of bite forceBaseline, 4 weeks, 3 months, 6 months, 12 months.Maximum voluntary bite force measured in Newtons at baseline, and change of bite force compared to baseline.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026