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临床试验/CTRI/2025/01/079081
CTRI/2025/01/079081尚未招募3 期

Effect of Four Different Irrigants as a Final Rinse on Post Operative Pain Following Single Sitting Root Canal Treatment in Symptomatic Irreversible Pulpitis: A Randomised Control Trial.

Dr. Aarya Rajan Mankodi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Post Operative Pain

研究概览

简要总结

Postoperative pain is a usual and unpredictable outcome of endodontic treatment. Different studies show that prevalence of Post Operative pain is 3% to 58%. It is the yardstick of clinician’s skill according to the patients. Symptomatic Irreversible pulpitis is a pulpal pathosis that requires Root Canal treatment. Just like any other inflamed tissue, inflamed pulp cells showed the presence of COX-2 positive cells. Steroidal anti-inflammatory agents function by inhibiting phospholipase-A2, while non-steroidal anti-inflammatory drugs operate by blocking cyclooxygenase enzymes, resulting in a decrease in levels of prostaglandins and leukotrienes. Dexamethasone is a potent steroid with great anti-inflammatory action. Diclofenac Sodium is a preferential COX-2 inhibitor. Ketorolac tromethamine, a potent NSAID, is over 400 times more potent as a selective inhibitor of COX-1 and COX-2 than  many other drugs  

Well done and copious irrigation is a must for a successful endodontic treatment.

In recent times , there has been a peaked interest to scope out newer irrigants that are multi faceted i.e. disinfection as well as provide symptomatic relief.  There are many studies to compare newer irrigants and effects on post operative pain.  The irrigants selected in this study have proven to provide symptomatic relief on oral consumption i.e. systemic administration.  It is also known that local deposition of drug has increased bioavailability than systemic administration .There are no studies which compare Diclofenac Sodium, Dexamethasone, Ketorolac Tromethamine to be used as an irrigants and a final rinse check its effect on Post Operative Pain.

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 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Healthy patients aged between 18-60 years.
  • 2.Permanent mandibular single rooted teeth with complete root formation.
  • 3.Permanent mandibular single rooted teeth with diagnosis of symptomatic irreversible pulpitis.

排除标准

  • 1.Patients who are medically compromised.
  • 2.Patients who had taken antibiotics in last 1 month and non-steroidal anti-inflammatory drugs 24 hours prior to procedure.
  • 3.Patients contraindicated for Diclofenac Sodium, Ketorolac Tromethamine, Lignocaine, use of apex locator 4.Patients allergic to latex 5.Patients who are denied consumption of steroids due various reasons.
  • 6.Patients who have renal and hepatic disorder 7.Patients with loss of tooth structure such that a rubber dam cannot be applied.
  • 8.Pregnant and lactating women.
  • 9.Adjacent carious teeth which are suspected of pulpal involvement.
  • 10.Immature teeth or teeth with root resorption.
  • 11.Teeth with calcified canals.
  • 12.Teeth with sinus opening or periapical radiolucency with PAI score of 3 or higher.

结局指标

主要结局

Post Operative Pain

时间窗: 6 hours, 24 hours, 48 hours, 72 hours

次要结局

  • Post Operative Analgesic Consumption(6 hours, 24 hours, 48 hours, 72 hours)

研究者

发起方
Dr. Aarya Rajan Mankodi
申办方类型
Other [Self Sponsored]
责任方
Principal Investigator
主要研究者

Dr Aarya Rajan Mankodi

Government Dental College and Hospital Nagpur

研究点 (1)

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