Evaluation of the Effects of Dry Needling and Botulinum Toxin Applications on VAS Scores and Muscle Thickness in the Masseter and Temporalis Muscles of Patients Diagnosed With Bruxism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Pain Intensity Measured by Visual Analog Scale (VAS)
研究概览
简要总结
- Aim: The aim of this study is to prospectively compare the clinical efficacy of Dry Needling (DN), Nabota (PrabotulinumtoxinA), and Dysport (AbobotulinumtoxinA) treatments on the thickness of masseter and anterior temporal muscles and pain intensity (VAS) in patients diagnosed with chronic bruxism.
- Material and Method: This randomized, prospective, and single-blind clinical study will be conducted on 60 patients diagnosed with bruxism. Patients will be divided into three groups: Dry Needling (n=20), Nabota (n=20), and Dysport (n=20). Pain levels will be assessed using the Visual Analog Scale (VAS) at baseline, 1st month, and 3rd month. Muscle thicknesses will be measured using ultrasonography (USG) at baseline and 3rd month. Data distribution will be analyzed using the Kolmogorov-Smirnov test; intergroup comparisons will be performed using ANOVA and Post-hoc Duncan tests.
- Results:The results will be analyzed following the completion of the 3-month follow-up period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years diagnosed with "Probable Bruxism". ASA I or ASA II physical status. Patients with severe pain, defined as a score of 8 or higher on a 0-10 Visual Analogue Scale (VAS) (where 0 = no pain and 10 = worst possible pain).
排除标准
- •Allergy to botulinum toxin, silver, or gold. Pregnancy, neuromuscular diseases, or bleeding disorders. Previous TMJ surgery or current use of other treatments.
研究组 & 干预措施
Dry Needling Group
Patients in this group received deep dry needling treatment. The procedure was performed once a week for a total of three sessions. Sterile needles (0.25x25 mm) were applied to myofascial trigger points in the masseter and anterior temporal muscles.
干预措施: Dry Needling (DN) (Procedure)
PraBotulinumtoxinA
Patients received a single-session injection of 50 Units (U) of PrabotulinumtoxinA. The total dose was distributed bilaterally as 15U for each masseter muscle (at 3 points) and 10U for each anterior temporal muscle (at 2 points).
干预措施: PrabotulinumtoxinA (Drug)
AbobotulinumtoxinA
Patients received a single-session injection of approximately 167 Units (U) of AbobotulinumtoxinA. The total dose was distributed bilaterally as 50U for each masseter muscle (at 3 points) and approximately 33U for each anterior temporal muscle (at 2 points).
干预措施: Abobotulinumtoxina (Drug)
结局指标
主要结局
Pain Intensity Measured by Visual Analog Scale (VAS)
时间窗: Baseline, 1 month, and 3 months.
Self-reported pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain). Measurements were taken at baseline, 1 month, and 3 months post-treatment.
Masseter and Anterior Temporal Muscle Thickness Via Ultrasonography (USG)
时间窗: 3rd month post-treatment.
Measurement of the thickness of the masseter and anterior temporal muscles in millimeters (cm) using a high-frequency linear probe. Measurements are taken bilaterally both at rest and during maximum voluntary contraction (clenching).
Visual Analog Scale (VAS) Score for Pain Intensity
时间窗: Baseline (Day 0), 1st month, and 3rd month post-treatment.
Patients are asked to rate their current pain level on a 100 mm (or 10 cm) horizontal line, where 0 represents "no pain" and 10 represents "the worst possible pain." Higher scores indicate greater pain intensity.
Masseter and Anterior Temporal Muscle Thickness via Ultrasonography (USG)
时间窗: Baseline (Day 0) and 3rd month post-treatment.
Measurement of the thickness of the masseter and anterior temporal muscles in millimeters (mm) using a high-frequency linear probe. Measurements are taken bilaterally both at rest and during maximum voluntary contraction (clenching).
次要结局
未报告次要终点
研究者
Şamil Güven
DDS, Resident in Oral and Maxillofacial Surgery
Recep Tayyip Erdogan University