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Completed

NCT Number: NCT05309564

Muscle Weakness Duration After Single Botulinum Toxin Injection in Masseter

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).

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Key information

Conditions

Bite Force Botulinum Toxins, Type A

Age range

18 year–120 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Norrlands universitetssjukhus

Umeå, Västerbotten County, 90185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume.

Exclusion criteria

Conditions or drugs affecting the central nervous system.

Treatment and study plan

Botulinum Toxin Type A

Drug

Single intervention

Other names: Xeomin

Primary outcomes

  1. Change of bite force

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

Region Västerbotten

Other Gov

Collaborators

  • Mahidol University
  • Umeå University

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2022
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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