Assessment of Injectable Platelet-rich Fibrin With Hyaluronic Acid Versus Hyaluronic Acid in Management of Temporomandibular Joint Internal Derangement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- pain intensity at TMJ during spontaneous mouth opening and with articular palpation and forced opening
研究概览
简要总结
Injectable PRF technology, according to literature evidence, ensures the release of growth factors over time which play a major role in the release of regenerative factors for tissue repair after injection, while HA is an anti-inflammatory medication that can provide rapid relief from pain and inflammation in joints. It is a major natural component of synovial fluid that plays an important role in lubrication of synovial tissues However, its effect is typically temporary, and it doesn't promote tissue healing or regeneration.
For this reason, this protocol has been designed with the aim to investigate whether injection in the injection i- pRF with HA can achieve the same improvements of pain and function, compare this technique with arthrocentesis.
详细描述
One group will receive arthrocentesis only, the second group will receive 1 mm hyaluronic acid injection and the third group will receive a mixture of 1 ml hyaluronic acid, 1 ml of injectable PRF
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of TMJ-ID related symptoms.
- •Patients suffering from TMJ internal derangement (disc displacement with reduction).
- •Age limit between 20 and 45years so Patient less than 21years will need assent form ...as well as written informed consent from the parents \guardians.
- •No previous TMJ surgical procedures
- •Acquisition of informed consent.
- •Cooperative patient
- •Patients free from any systemic disease that may affect the procedure.
排除标准
- •Previous malignant head and neck neoplasms.
- •Patients suffering from inflammatory or connective tissue systemic diseases.
- •Neurologic disorders.
- •History of bony or fibrous adhesion
- •Gross mechanical restrictions and condylar fractures, previous TMJ surgery, TMJ ankylosis, or acute infection.
- •Patients maintained on anti-coagulants, muscle relaxants, non-steroidal anti-inflammatory drugs within 48 h preoperatively, corticosteroid injection at treatment site within one month or systemic use of corticosteroids within 2 weeks was also excluded in this study.
- •Uncooperative patient
- •Pregnant and lactating female.
- •Patients with systemic diseases (e.g., rheumatoid arthritis, psoriatic arthritis, or juvenile arthritis), and those who had shown symptoms of hypersensitivity to the HA solution.
结局指标
主要结局
pain intensity at TMJ during spontaneous mouth opening and with articular palpation and forced opening
时间窗: evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.
Pain measured through a (10 scale) visual analogue scale (VAS)
Maximum mouth opening
时间窗: evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.
mandibular mouth opening defined as MIO (maximum interincisal opening) \>/35
次要结局
- MRI disc angle changes(preoperative examination (baseline) and 6 months after the procedure.)
研究者
Baghdad Mohammed abdo-alhage
Principal researcher at oral and Maxillofacial surgery department
Cairo University