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临床试验/NCT07691684
NCT07691684已完成不适用

Evaluation of the Efficacy of Intra-Articular Injection of Platelet-Rich Plasma Versus Dexamethasone With Local Anaesthetic in the Treatment of Internal Derangement of the Temporomandibular Joint: A Randomised Controlled Trial

University Of Anbar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月10日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Change in Pain Intensity (VAS)

研究概览

简要总结

This study looked at whether an injection into the jaw joint (temporomandibular joint, or TMJ) can help people who have pain, clicking, and difficulty opening their mouth due to a slipped joint disc. Thirty patients were randomly assigned to receive one of three injections: platelet-rich plasma (PRP, made from the patient's own blood), a steroid medication (dexamethasone) with a local anesthetic, or a saline (salt water) injection as a comparison. Pain, joint clicking, and mouth opening were measured before the injection and one week later. The study found that both PRP and the steroid injection reduced pain and clicking more than saline, and PRP also improved how wide patients could open their mouth.

详细描述

This was a prospective, parallel-group, three-arm randomised controlled trial conducted at the outpatient clinics of the Maxillofacial and Oral Surgery Division, College of Dentistry, University of Anbar, Ramadi, Iraq. Thirty temporomandibular joints (30 patients) with clinically diagnosed disc displacement with reduction, per DC/TMD Axis I criteria, were randomised 1:1:1 by an independent statistician using a computer-generated sequence, with allocation concealed via sequentially numbered opaque envelopes. The outcome assessor was blinded to treatment allocation throughout follow-up. Patients in the dexamethasone and saline arms were not informed of their specific assignment; full blinding was not feasible for the PRP arm due to the visible blood draw and processing required. All three injections used an identical preauricular approach, injection site, needle gauge, and volume (1 mL) to standardise the procedural experience across groups. Within- and between-group differences were analysed using the Wilcoxon signed-rank test and Kruskal-Wallis test with Dunn post-hoc comparisons. This trial was registered retrospectively after enrolment and follow-up were complete.

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, Outcomes Assessor)

盲法说明

"Outcome assessor was fully blinded throughout follow-up. Participants in the dexamethasone and saline arms were blinded to allocation; full blinding was not feasible in the PRP arm due to the visible blood-draw and processing procedure

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Skeletally mature patients aged 18 years or older
  • Symptomatic TMJ internal derangement in the form of disc displacement with reduction (DDwR), diagnosed using DC/TMD Axis I clinical criteria
  • TMJ arthralgia confirmed by pain reproduced on palpation or provoked by jaw movement
  • Clicking sound detectable on palpation or auscultation during opening and closing movements
  • Elimination or marked reduction of the click on mouth opening from a protruded position

排除标准

  • Intra-articular injection within the previous six months
  • Systemic inflammatory arthropathy
  • Coagulopathy
  • Active local infection
  • Low platelet count
  • Ongoing antiplatelet or anticoagulant therapy
  • Pregnancy

结局指标

主要结局

Change in Pain Intensity (VAS)

时间窗: Baseline and 1 week post-injection

Pain intensity rated on a 10-cm visual analogue scale (0=no pain, 10=worst imaginable pain), reflecting the most intense pain during function.

次要结局

  • Change in Joint Sound (Clicking)(Baseline and 1 week post-injection)
  • Change in Maximum Interincisal Opening (MIO)(Baseline and 1 week post-injection)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hussein Salam Abdulraheem Twayej

Postgraduate Researcher

University Of Anbar

研究点 (1)

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