The Platelet -Rich Plasma in the Therapy of Temporomandibular Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Pain intensity reduction in VAS scale,(VAS scale 0-10 points)
研究概览
简要总结
The Platelet-Rich Plasma intramuscular injections into the masseter and temporalis muscle were performed to reduce painful temporomandibular disorder symptoms,such as myalgia, myofascial pain and myofascial pain with referrals. Patients(n=120) were randomly divided into two groups: experimental(n=60) and control group(n=60). In controls injections with 0,9% NaCl were performed. Pain intensity was measured with NPRS (numeriic pain rating scale, 0= no pain, 11= the worst pain that one can imagine) before(0 day), during(10 day) and after(20 day) the therapy with PRP injections.
详细描述
Patients(n=120) attending The Department of Temporomandibular Disorders and Orthodontics at the Silesian Medical University Poland, Zabrze were enrolled to the study and randomly divided into one of two groups: experimental and control group. Platelet-Rich Plasma(PRP) was prepared for each patient and an intramuscular injections of 0,5 ml PRP into 6 points at each side were performed in experimental group. A follow-up appointment was made after 10 and 20 days and in each visit an injection of PRP or 0,9% NaCl was performed. Pain intensity was measured in NPRS(numeric pain rating scale) and collected data data were analyzed.
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, Care Provider)
盲法说明
double blinded study
入排标准
- 年龄范围
- 23 Years 至 42 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •presence of local myalgia, myofascial pain and myofascial pain with referral within masseter muscles according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) (II.1.A. 1, 2 and 3)
- •patient's agreement for taking part into the research study
排除标准
- •patients being treated with or addicted to analgesic drugs and/or drugs that affect muscle function
- •presence of contraindications for injection therapy
- •patients being treated by neurologist for neurological disorders and/or neuropathic pain and/or headache
- •patients after traumas to the head and neck region in the previous 2 years
- •edentulous patients
- •patients after radiotherapy
- •presence of severe mental disorders
- •pregnancy or lactation
- •pain of dental origin
- •presence of malignancy
- •drug and/or alcohol addiction
- •patients with needle phobia
研究组 & 干预措施
PRP injections
Intramuscular injection of Platelet-Rich Plasma into the masseter and temporalis muscle
干预措施: Platelet-Rich Plasma intramuscular injections (Biological)
0,9% NaCl injections
Intramuscular injection of 0,9% NaCl into the masseter and temporalis muscle
干预措施: Placebo Comparator: 0,9% NaCl intramuscular injections (Biological)
结局指标
主要结局
Pain intensity reduction in VAS scale,(VAS scale 0-10 points)
时间窗: 14 days
Decrease in pain intensity in masseter and temporalis muscles.
次要结局
未报告次要终点
研究者
Aleksandra Nitecka-Buchta
DMD, PhD
Medical University of Silesia