跳至主要内容
临床试验/CTRI/2024/12/078787
CTRI/2024/12/078787招募中2/3 期

To evaluate the efficacy of Intra-articular injectable platelet-rich fibrin with arthrocentesis versus arthrocentesis alone in the management of temporomandibular joint internal derangement: A Prospective Study

Government College of Dentistry Indore1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月2日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
to evaluate the efficacy of arthrocentesis with and without i-PRF injection in upper joint space on the improvement of symptoms and jaw function in management of TMJ internal derangement.

研究概览

简要总结

In this prospective interventional hospital-based study, with temporomandibular joint & internal derangement patients attending OPD of Oral and Maxillofacial Surgery Govt. College of Dentistry Indore Madhya Pradesh, India. Informed consent will be obtained from each patient enrolled in the study. 40 patients will be included in this study. All patients will be treated using the same method. These 40 patients will be divided into two groups of for namely group I and group 2.

In group l patients, arthrocentesis will be planned and In group 2 patients, arthrocentesis with i-PRF will be planned. Preoperative inter-incisal distance will be measured using Vernier calibre

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 55.00 Year(s)(—)
性别
All

入选标准

  • The study included patient aged 18-55 years.
  • suffering from TMJ internal derangement with reduction and patient who have given consent.
  • All the patients whose condition was refractory to conservative treatment were included in the study.

排除标准

  • Patients suffering from TMJ related Disorder other than Internal derangement.
  • 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.
  • Patients who were pregnant or in the lactation period.
  • Patients who were edentulous were excluded.

结局指标

主要结局

to evaluate the efficacy of arthrocentesis with and without i-PRF injection in upper joint space on the improvement of symptoms and jaw function in management of TMJ internal derangement.

时间窗: Baseline | 1 week | 1 month | 2 months | 3 months | 6 months

次要结局

  • 1) To compare preoperative and postoperative pain in TMJ using Visual analogue scale.(2)To compare maximum mouth opening both pre and post operatively.)

研究者

发起方
Government College of Dentistry Indore
申办方类型
Other [Government Medical College ]
责任方
Principal Investigator
主要研究者

Dr. Sachin Jha

Government College Of Dentistry Indore

研究点 (1)

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