跳至主要内容
临床试验/CTRI/2024/12/078636
CTRI/2024/12/078636已完成Phase 3 4

COMPARATIVE EVALUATION OF POST OPERATIVE SEQUELAE BY USING PNEUMATIC PUMP CONTINUOUS IRRIGATION WITH MANUAL IRRIGATION FOR SURGICAL EXTRACTION OF MANDIBULAR THIRD MOLAR

Dr sharda soni1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年1月20日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
54
试验地点
1
主要终点
The study result will help us to know the influence of pneumatic pump continuous irrigation with manual irrigation in the post operative inflammatory sequelae after surgical extraction of third molars.

研究概览

简要总结

The present study aims to evaluate and compare the influence of pneumatic pump continuous irrigation with manual irrigation on post operative inflammatory sequelae following surgical extraction of similarly placed mandibular third molars bilaterally. A split-mouth randomized controlled clinical trial will be conducted among 27 patients to evaluate the effect of pneumatic pump continuous irrigation versus manual irrigation on pain, edema, and trismus after surgical extraction of mandibular third molars. The study will include patients needing surgical extraction of impacted third molars who willingly participate and agree to the postoperative follow-up. Each patient will serve as both the test group (physiodispenser with pneumatic pump continuous irrigation) and the control group (conventional rotary instrument with manual irrigation). Randomization for irrigation method and which side of the tooth would be extracted from will be determined via a lottery method.

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 and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Patient who requires prophylactic surgical removal of bilaterally impacted mandibular third molar (Mesioangular class II, position A).
  • Patient aged below 30 years.
  • Patients coming under American Society of Anesthesiologists (ASA) I.
  • No contra-indication to the drugs or anesthetic which will be used in the surgical protocol.
  • Patient willing to participate and has given written informed consent.

排除标准

  • Acute Pericoronitis.
  • Pregnant and lactating women
  • Patient with chronic use of medication such as antihistaminic, nonsteroidal anti-inflammatory drugs which would complicate evaluation of their postoperative response.
  • Patient coming under category of American society of anesthesiologist II III and IV.

结局指标

主要结局

The study result will help us to know the influence of pneumatic pump continuous irrigation with manual irrigation in the post operative inflammatory sequelae after surgical extraction of third molars.

时间窗: o day, 1st day, 3rd day, 7th day

次要结局

  • The results could contribute to the development of new irrigation methods in oral surgery which will enhance clinical practice and can be used for further research.(0,1,3,7 day)

研究者

发起方
Dr sharda soni
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr sharda soni

Government Dental College and Hospital Raipur

研究点 (1)

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