Repeated Botulinum Toxin Type A Injections on the Masseter Muscle of Individuals With Sleep Bruxism: A Longitudinal Ultrasonographic Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Ultrasonographic imaging
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
The radiologist who acquired the ultrasonographic data and the researcher who performed the cross-sectional fat infiltration analysis were completely blinded to each other's procedures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Clinical diagnosis of probable sleep bruxism according to the international consensus criteria proposed by Lobbezoo et al.
- •Indication for BoNT-A injection in the masseter muscle due to bruxism-related pain or muscle hypertrophy.
- •Willingness to undergo repeated BoNT-A injections at six-month intervals.
- •Willingness to participate in ultrasonographic evaluations at each follow-up visit.
排除标准
- •Presence of neurological or neuromuscular disorders affecting the masticatory muscles (e.g., dystonia, myasthenia gravis).
- •History of orofacial trauma, temporomandibular joint dysfunction, or maxillofacial surgery.
- •Systemic diseases that may affect neuromuscular transmission or muscle metabolism.
- •Use of medications known to interfere with neuromuscular function, including aminoglycoside antibiotics or corticosteroids.
结局指标
主要结局
Ultrasonographic imaging
时间窗: From enrollment to 6 months
Cross-sectional imaging was obtained from the same anatomical plane. The probe position was determined at each visit using consistent anatomical landmarks-specifically the lower border of the mandibular corpus and the thickest region of the masseter muscle. The imaging plane part of the masseter, located between the posterior border adjacent to the parotid gland and the anterior border of the mandibular ramus. Ultrasonographic images were acquired both at rest (RST) and during maximum voluntary contraction (MVC) under identical device settings by the same experienced radiologist.
次要结局
未报告次要终点
研究者
Melek Volkan Yazici
Associate Professor
Yuksek Ihtisas University