Comparison of intra-articular injection of platelet rich fibrin (i-prf) as a stand-alone treatment modality with concomitant use of arthrocentesis and i-prf in patients with temporomandibular disorders - a randomised clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of pain—VISUAL ANALOGUE SCALE (horizontal graded linear)
研究概览
简要总结
Temporomandibular disorders represent a wide range of functional changes and pathological conditions affecting the temporomandibular joint, masticatory muscles, and other components of the oro-maxillofacial region. In recent years, TMD has become a frequent cause for seeking medical assistance. Their multifactorial etiology and diverse presentation necessitate evidence-based, minimally invasive management strategies tailored to optimize clinical outcomes.
Management is mainly focused on relieving the functional pain and re-establishing normal range of mandibular function. From the range of surgical alternatives available, arthrocentesis has been widely used since many decades. In conjunction with arthrocentesis, intra-articular administration of various substances has been used. The injectables studied so far include corticosteroids, hyaluronic acid, tenoxicam, morphine, bupivacaine, local anaesthesia-steroid combination, hypertonic dextrose, analgesics, ozone, and auto-derived preparations. The currently used autologous products are mainly substances obtained from the patient’s centrifuged blood: platelet-rich plasma, plasma rich in growth factor, and injectable platelet-rich fibrin, of the most favourable composition.
Arthrocentesis followed by intra-articular injection of i-PRF has been the standard of care recently. The advantage of injecting PRF in TMJ is that each PRF injection causes a mechanical tear of adhesions through a hydraulic distension and expansion of the superior articular space, thereby eliminating the vacuum effect present in osteoarthritis.It is established that PRF can reduce pain and has growth factors incorporated.
At present, PRF has more advantages and appears be a better choice, whereas further research is required to prove the long-term efficacy of PRF to avoid the invasive procedure of arthrocentesis.
Intraarticular administration of i-PRF is better tolerated by the patient owing to its less invasiveness. Evaluating the effectiveness of arthrocentesis prior to administration of intra-articular injection of i-PRF is necessary to prevent over-treating the joint. The lack of RCTs on the intra-articular administration of I-PRF as a stand-alone procedure encourages further research.Hence, we have proposed to conduct a Randomised Clinical Trial to compare the efficacy of intra-articular injection of i-PRF as a stand-alone treatment modality to the current trend of arthrocentesis followed by intra-articular injection of i-PRF in patients with Temporomandibular disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with TMD Wilkes stage III, IV, V (DC TMD Criteria 2015) Patients not having relief from conservative treatment for at least 3 months with VAS score more than 5 Age group 18-65 years, regardless of gender Patients willing to give written informed consent.
排除标准
- •Autoimmune disorders -Benign or malignant lesion of the temporomandibular joint, Neurological disorders- Bruxism Blood disorders and coagulopathies Patients with a history of allergy or anaphylactic shock Severe malocclusion- Crowding, Anterior deep bite Patients with acute infectious disorders.
结局指标
主要结局
Assessment of pain—VISUAL ANALOGUE SCALE (horizontal graded linear)
时间窗: Evaluation will be carried out at 14 days, 1 month, 2 months and 3 months post intervention. The change in VAS score [from baseline to VAS at 3 months (VAS T4)] will be considered as the primary outcome.
次要结局
- The range of mandibular motion (maximum unassisted opening (MUO), maximum assisted opening (MAO), protrusive movement (PM), right lateral excursion (RLE) and left lateral excursion (LLE)(Evaluation will be carried out at 14 days, 1 month, 2 months and 3 months post intervention. The change in VAS score [from baseline to VAS at 3 months (VAS T4)] will be considered as the primary outcome.)
- Tenderness of masticatory muscles (masseter and temporalis) – by manual palpation(Evaluation will be carried out at 14 days, 1 month, 2 months and 3 months post intervention. The change in VAS score [from baseline to VAS at 3 months (VAS T4)] will be considered as the primary outcome.)
- Clicking sound and crepitus(Evaluation will be carried out at 14 days, 1 month, 2 months and 3 months post intervention. The change in VAS score [from baseline to VAS at 3 months (VAS T4)] will be considered as the primary outcome.)
研究者
Kirthi George
Post graduate institute of medical education and research, Chandigarh