Muscle Weakness Duration After Single Botulinum Toxin Injection in Masseter

NCT ID: NCT05309564

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-03-14

Brief Summary

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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

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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.

Conditions

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Bite Force Botulinum Toxins, Type A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Intervention with single botulinum neurotoxin injection into masseter.

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type DRUG

Single intervention

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Botulinum toxin type A

Single intervention

Intervention Type DRUG

Other Intervention Names

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Xeomin

Eligibility Criteria

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Inclusion Criteria

Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume.

Exclusion Criteria

Conditions or drugs affecting the central nervous system.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Umeå University

OTHER

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role collaborator

Region Västerbotten

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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2020-03517 Pettersson, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

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Norrlands universitetssjukhus

Umeå, Västerbotten County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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BTX-Thailand

Identifier Type: -

Identifier Source: org_study_id

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