Muscle Weakness Duration After Single Botulinum Toxin Injection in Masseter

Not Applicable

Completed

• Conditions: Bite Force; Botulinum Toxins, Type A
• Interventions: Drug: Botulinum toxin type A

• Registration Number: NCT05309564
• Lead Sponsor: Region Västerbotten

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.

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2022-01-10
• Study Completion: 2022-03-14
• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-04-01
• Study First Posted: 2022-04-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume.

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Exclusion Criteria

Conditions or drugs affecting the central nervous system.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Botulinum toxin type A	Intervention with single botulinum neurotoxin injection into masseter.

Primary Outcome Measures

Name	Time	Method
Change of bite force	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.

Trial Locations

Locations (1)

Norrlands universitetssjukhus; 🇸🇪 Umeå, Västerbotten, Sweden