Quantitative Ultrasonographic Assessment of Masseter Muscle Changes Following Botulinum Toxin Injection in Patients With Bruxism: A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Masseter Muscle Thickness
研究概览
简要总结
This prospective pilot study aimed to evaluate short-term clinical and ultrasonographic changes in the masseter muscle following botulinum toxin injection in patients with bruxism. Clinical assessments included pain evaluation using the Visual Analog Scale (VAS), while ultrasonographic evaluation included measurement of masseter muscle thickness and quantitative texture analysis using fractal dimension and histogram parameters. Measurements were performed at baseline, 14 days, and 90 days after treatment. The study aimed to assess both macroscopic and microstructural changes in the muscle tissue.
详细描述
This study investigated the short-term effects of botulinum toxin injection on the masseter muscle in patients with bruxism using quantitative ultrasonographic methods. All participants received bilateral botulinum toxin injections into the masseter muscle using a standardized technique. Ultrasonographic examinations were performed using a high-frequency linear probe. Masseter muscle thickness was measured at a standardized anatomical location during maximal clenching.
For quantitative texture analysis, a fixed-size region of interest (ROI) was placed in the central intramuscular portion of the masseter muscle while avoiding fascia, bone, and artifacts. Fractal analysis was performed using the box-counting method to assess structural complexity, while histogram analysis was used to evaluate grayscale pixel distribution reflecting echotexture characteristics.
Clinical and ultrasonographic measurements were recorded at baseline, 14 days, and 90 days post-injection. The study aimed to determine whether botulinum toxin induces not only functional and morphological changes but also microstructural alterations in muscle tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking was applied in this study. All participants received the same intervention, and both participants and investigators were aware of the treatment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-60 years Clinically diagnosed with bruxism Scheduled for botulinum toxin injection into the masseter muscle Willing to participate and provided written informed consent Completed all follow-up visits (baseline, Day 14, and Day 90)
排除标准
- •Previous botulinum toxin injection to the masseter muscle Presence of neuromuscular disorders affecting masticatory muscles History of temporomandibular joint surgery Pregnancy or breastfeeding Presence of trauma, infection, or mass in the masseter region Any condition that may interfere with ultrasonographic evaluation Failure to complete follow-up visits
研究组 & 干预措施
Botulinum Toxin Group
Participants received bilateral botulinum toxin injections into the masseter muscle using a standardized injection protocol. Clinical and ultrasonographic assessments were performed at baseline, 14 days, and 90 days post-treatment.
干预措施: Botulinum Toxin A (Botox ) (Drug)
结局指标
主要结局
Masseter Muscle Thickness
时间窗: Baseline, Day 14, Day 90
Change in masseter muscle thickness measured in millimeters using ultrasonography at baseline, 14 days, and 90 days following botulinum toxin injection.
次要结局
- Pain Intensity (VAS Score)(Baseline, Day 14, Day 90)
- Fractal Dimension of Masseter Muscle(Baseline, Day 14, Day 90)
- Ultrasound Echotexture (Histogram Analysis)(Baseline, Day 14, Day 90)
研究者
AYŞE GÜL ÖNER TALMAÇ
Assistant Professor
Kahramanmaras Sutcu Imam University