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

Efficacy and safety of using Botulinum Toxin type A in the Masseter Hypertrophy treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7tdjcn5
Enrollment
Unknown
Registered
2024-01-24
Start date
2022-12-17
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Masseter muscle

Interventions

Volunteers will be randomized into 2 groups: G1 (n=13) which will receive a single application of TxB-A on the masseter muscle bilaterally and at 3 months they will receive saline solution and G2 (n=

Sponsors

Faculdade Ingá - UNINGÁ/Paraná
Lead Sponsor
Associação Brasileira de Odontologia- Secção Goiás
Collaborator

Eligibility

Sex/Gender
Female
Age
25 Years to 50 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactLuciana Machado

Faculdade Ingá - UNINGÁ/PR

lu_oresende@hotmail.com+5562991785589

Outcome results

None listed

Source: REBEC (via WHO ICTRP)