NCT07266064

Repeated Botulinum Toxin Type A Injections on Intramuscular Fat Accumulation in Individuals With Sleep Bruxism.

Repeated Botulinum Toxin Type A Injections on the Masseter Muscle of Individuals With Sleep Bruxism: A Longitudinal Ultrasonographic Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Melek Volkan Yazici · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates whether repeated botulinum toxin type A (BoNT-A) injections used to manage sleep bruxism lead to structural changes-specifically intramuscular fat accumulation-in the masseter muscle. Adults with probable sleep bruxism receive BoNT-A injections every six months and undergo ultrasound evaluations before each injection. By tracking fat percentage in the masseter muscle over multiple treatment cycles, the study aims to determine whether long-term BoNT-A use causes progressive structural alterations or remains safe for repeated clinical use.

Detailed description

Botulinum toxin type A (BoNT-A) is commonly used for the management of sleep bruxism, yet concerns persist regarding its long-term effects on muscle structure, including the possibility of intramuscular fat accumulation in the masseter muscle. This prospective longitudinal study follows adults with probable sleep bruxism who receive bilateral BoNT-A injections at six-month intervals. Ultrasound imaging is performed immediately before each injection, resulting in four injection cycles and five standardized ultrasound assessments. Intramuscular fat percentage is quantified from B-mode images at rest and during maximum voluntary contraction using binary segmentation techniques. By examining changes over repeated treatment cycles, the study evaluates whether BoNT-A leads to progressive fat infiltration or instead demonstrates a stable or adaptive pattern. Findings will help clarify the structural safety of long-term BoNT-A use in non-spastic masticatory muscles and guide clinical decision-making for ongoing bruxism management.

Conditions

• Bruxism
• Bruxism, Sleep
• Bruxism, Sleep-Related

Interventions

Type	Name	Description
OTHER	Botilinum Toxin injection	This prospective longitudinal interventional study included adults with probable sleep bruxism who received bilateral BoNT-A injections every six months, with ultrasonographic assessments also performed at six-month intervals, immediately before each new injection. The protocol therefore comprised four injection cycles and five ultrasound sessions. Ultrasonographic evaluations were conducted before the first injection and six months after each subsequent injection to quantify intramuscular fat percentage at rest and during maximum voluntary contraction. Fat area percentage was computed from standardized B-mode images using binary segmentation in CT-Analyzer software.

Timeline

• Start date: 2024-01-02
• Primary completion: 2025-11-20
• Completion: 2025-11-20
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: Turkey (Türkiye)