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临床试验/NCT05532098
NCT05532098招募中不适用

Comparative Efficacy of Platelet Rich Plasma and Dry Needling in Management of Anterior Disc Displacement of Temporomandibular Joint

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
78
试验地点
2
主要终点
Pain intensity

研究概览

简要总结

Pain and trismus are of the prime concerns for the patients in case of Anterior disc displacement ADD of temporomandibular joint (TMJ). In the recent times, PRP has has produced promising results in management of TMDs. It has potential healing properties on new bone and cartilage through the recruitment, proliferation, migration, and differentiation of cells and its tissue remodelling, matrix production, and chondrogenic differentiation properties. It also increases the production of hyaluronic acid by synoviocytes. Needle injury also produces immediate analgesia without hypesthesia, mainly on the painful spot making it effective for the pain reduction and improved mouth opening. Similar effect of dry needling can also be expected in the joint space where it may induce a transient inflammatory cascade leading to healing of the damaged tissue.

So, the Present study is designed to evaluate the efficacy of PRP for the treatment of ADD of TMJ.

详细描述

Study Design: Randomized clinical trial Study Duration: This study will be completed in 1 year 3 months (3 months for patient recruitment, 9 months for study including treatment and follow up and 3 months for data compilation).

Population: Patients suffering from Anterior Disc Displacement will be recruited in study from regular OPD of the Department of Oral Medicine and Radiology.

Sample size: Sample size consists of 39 patients in each group. Methods: PRP will be performed in test group while dry needling will be performed in control group.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with Anterior disc displacement clinically according to TMD/RDC criteria (2013-14).
  • Patients diagnosed with Anterior disc displacement confirmed using Magnetic Resonance Imaging.

排除标准

  • Patients with phobia to needles
  • Patients who have undergone previous treatment for anterior disc displacement in past 6 months
  • Patients with active infection at the site of injection
  • Patients on anticoagulant medication
  • Pregnancy/ Lactation
  • Patients with healing disorder or systemic disease where healing response is compromised
  • Patients with epilepsy/seizures
  • Patients with bleeding and clotting disorder
  • Patients with malignancy
  • Patients with uncontrolled para-functional habits

结局指标

主要结局

Pain intensity

时间窗: 6 months

To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).

Mouth opening and Functional movements

时间窗: 6 months

To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).

次要结局

  • Joint sounds(6 months)
  • Patient satisfaction(6 months)
  • Sleep pattern(6 months)
  • Pain medication(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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