Dry Needling Versus Stabilization Splint Therapy in Bruxism Associated Myofascial Temporomandibular Disorders: A Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain intensity (VAS)
研究概览
简要总结
This prospective comparative clinical study included 40 patients diagnosed with myofascial TMD who met the diagnostic criteria for bruxism established by the American Academy of Sleep Medicine. Participants were allocated into two groups according to treatment preference: stabilization splint therapy or dry needling. Maximum mouth opening (MMO), pain intensity assessed using the Visual Analog Scale (VAS), and Oral Health Impact Profile for TMD (OHIP-TMD) scores were recorded at baseline and at 1, 3, and 6 months post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Clinical presence of temporomandibular disorder (TMD) symptoms (e.g., joint sounds such as clicking, and/or limited mouth opening)
- •Diagnosis of bruxism according to the American Academy of Sleep Medicine (AASM) criteria
- •Moderate to severe pain in the masseter and/or temporalis muscles, defined as a Visual Analog Scale (VAS) score ≥3.5
排除标准
- •Presence of connective tissue disorders or autoimmune diseases
- •Current use of systemic steroids, muscle relaxants, or narcotic (opioid) medications
- •History of neuromuscular disorders
- •Previous temporomandibular joint (TMJ) surgery
- •History of significant TMJ trauma
- •Presence of dentofacial deformities
- •Any condition that, in the opinion of the investigator, may interfere with study participation or outcome assessment
研究组 & 干预措施
Dry Needling
Patients underwent dry needling applied to the masseter and temporalis muscles. The procedure was performed using sterile acupuncture needles in three sessions at 1-week intervals. Needles were inserted into identified trigger points and manually stimulated during each session.
干预措施: Dry Needling (Procedure)
Stabilization Splint Therapy
Patients received a maxillary hard acrylic stabilization splint designed to provide uniform occlusal contacts. Participants were instructed to use the splint for at least two-thirds of the day over a 6-month period, except during eating and oral hygiene procedures. Monthly follow-up visits were conducted for necessary adjustments.
干预措施: Stabilization Splint (Device)
结局指标
主要结局
Pain intensity (VAS)
时间窗: Baseline, 1 month, 3 months, and 6 months
Pain intensity was assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Measurements were recorded at baseline and during follow-up visits to evaluate changes in pain levels over time.
Maximum mouth opening (MMO)
时间窗: Baseline, 1 month, 3 months, and 6 months
Maximum mouth opening (MMO) was measured in millimeters as the distance between the incisal edges of the maxillary and mandibular central incisors at maximum painless mouth opening. This parameter was used to assess functional improvement in mandibular mobility.
次要结局
- Oral Health-Related Quality of Life (OHIP-TMD)(Baseline, 3 months, and 6 months)
研究者
Hatice Duran
Assos. Prof.
Kocaeli University