Effect of High-frequency Bio-oxidative Ozone Therapy for Masticatory Muscle Pain: a Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 1 month
研究概览
简要总结
This study investigates the efficacy of bio-oxidative ozone application in the treatment of TMD of muscular origin.
详细描述
Ozone is a natural pale blue gas that can be found in the atmosphere. Medical grade ozone is a powerful oxidizing agent which can be produced commercially in ozone generators. Ozone can have effects on blood components and positively affect oxygen metabolism, cell energy, immunomodulation and microcirculation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD)
- •Natural posterior occlusion.
排除标准
- •Any TMJ internal derangement
- •Inflammatory connective tissue disease
- •Psychiatric problem
- •Hearth disease or pacemaker
- •Pregnancy
- •Other orofacial region disease symptoms (e.g. toothache, neuralgia, migraine)
- •Treatment or medication use for headache or bruxism in the last 2 years
- •Local skin infection over the masseter or temporal muscle
研究组 & 干预措施
Placebo
Sham ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks
干预措施: Placebo (for Ozone) (Device)
Occlusal splint
Occlusal splint use every night over a period of 4 weeks.
干预措施: Dental treatment with occlusal splint (Device)
Ozone
Ozone application to the greatest points of pain in the related muscle, 3 times per week for 2 weeks
干预措施: Ozone (Device)
结局指标
主要结局
Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 1 month
时间窗: Change from Baseline Pain Values (kg/cm2) at 1 month
Patient-reported pain intensity data when the feeling of pressure become painful, at which time the pressure is stopped. Measurements were separated by 30-s rest periods.
Change From Baseline in Pain Values (kg/cm2) on the Pressure pain threshold measurement (PPT) using a Pressure Algometry at 3 months
时间窗: Change from Baseline Pain Values (kg/cm2) at 3 months
Patient-reported pain intensity data when the feeling of pressure become painful, at which time the pressure is stopped. Measurements were separated by 30-s rest periods.
Change From Baseline in Pain Scores on the Visual Analog Scale at 1 month
时间窗: Change from Baseline Pain Scores at 1 month
The measurement of subjective pain intensity is done using a 100-mm visual analogue scale.
Change From Baseline in Pain Scores on the Visual Analog Scale at 3 months
时间窗: Change from Baseline Pain Scores at 3 months
The measurement of subjective pain intensity is done using a 100-mm visual analogue scale.
次要结局
- Functional examination(Baseline, 1 month and 3 months)
研究者
Tamer Celakil
Research Assistant
Istanbul University