How safe is the use of Botulinum Toxin type A in the treatment of Masseter Hypertrophy?

Not Applicable

• Conditions: Masseter muscle; Skeletal Muscle Hypertrophy

• Registration Number: RBR-7tdjcn5
• Lead Sponsor: Faculdade Ingá - UNINGÁ/Paraná

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-10-15
• Study Start: 2024-01-24
• Last Update Posted: 5 March 2024

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Female patients; age between 25 and 50 years; complaining of enlargement of the lower third of the face; complaining of unilateral or bilateral hypertrophy of the masseter muscle; have not received aesthetic procedures on the lower third of the face in the last 12 months

Exclusion Criteria

Having received an anti-tetanus or COVID-19 vaccine within a period of less than three months, before starting the research; having previously received injections of botulinum toxin for aesthetic or therapeutic purposes; presenting autoimmune diseases; pregnant and lactating women; present neuromuscular diseases (Myasthenia gravis and Lambert-Eaton Syndrome); in current use of drugs that act on neuromuscular junctions; having performed cosmetic surgeries on the lower third of the face; missing teeth; individuals under 25 years of age; those who do not agree to sign the Free and Informed Consent Form; those who receive some type of vaccine during the research; received aesthetic procedures in the lower third of the face in the last 12 months

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to find a reduction in the thickness of the masseter muscle over a period of three and six months, verified through ultrasound, based on a variation of at least 5% in pre and post intervention assessments.;It is expected to find a reduction in mandibular bone volume over a period of three and six months, verified through cone beam computed tomography, based on a variation of at least 5% in pre and post intervention assessments.;It is expected to find a reduction in the electrical activity of the masseter muscle over a period of three and six months, verified through surface electromyography based on a variation of at least 5% in pre and post intervention assessments.

Secondary Outcome Measures

Name	Time	Method
It is expected to find a reduction in chewing performance over a period of three and six months, verified through the method of mixing two gums, based on a variation of at least 3% in the pre and post intervention assessments.