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临床试验/NCT05852444
NCT05852444已完成不适用

Comparison of Postoperative Pain After Using Passive Ultra Sonic Activation (PUA) and Manual Dynamic Agitation (MDA) During Root Canal Treatment

Armed Forces Institute of Dentistry, Pakistan2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Post Operative pain assessed by VAS after endodontic therapy

研究概览

简要总结

The study analyzes the difference in post operative pain after root canal therapy, after using different activation protocols and devices. The subjects are divided into 2 groups and a different activation protocol is used in each group. In one group, final activation of irrigating agent during root canal therapy is done with an ultrasonic activation device, and in the other group, manual dynamic agitation is done using master gutta percha cone. The Post operative pain is then compared at 8, 24,and 48 hour intervals

详细描述

Root canal therapy is a procedure in which inflamed pulp tissue and microorganisms are removed from root canals and pulp chamber, in order to eradicate infection and symptoms. Irrigation is a crucial step of an endodontic therapy and different methods and protocols are used to enhance the efficacy of irrigation. Ultrasonic activation of root canal irrigation agent is one of the effective methods that enhance the outcomes and success rate of endo therapies. It removes the smear layer, bacterial biofilms and debris by acoustic streaming and agitating the irrigant inside root canals. Similarly, a conventional method of agitation (manual dynamic agitation) also play an important role in endodontic therapy, particularly by improving the delivery of irrigation agent to the apex of a root canal. The later method involves agitation of irrigant with master gutta percha cone with continuous to and fro strokes manually.

In this study, the efficacy of both the different irrigation protocols will be compared and assessed based on post-operative pain, measured by Visual Analog Scale (VAS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants of the study and outcomes assessor would not know the details of groups, and only the investigator and care provider would be aware of that, as they cannot be blinded due to the nature of this study

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with unremarkable/ noncontributory medical history
  • Healthy persons between the ages of 18 and 60 years
  • Maxillary and mandibular molar teeth diagnosed with symptomatic irreversible pulpitis.
  • Patients not having taken any medication for 6 hours before treatment
  • No allergies to the drugs or dental material being used in the treatment

排除标准

  • Patients who had taken analgesics on anti-inflammatory drugs within the last 12 hours
  • Pregnant women and patients with immunocompromised health state
  • Patients having severe malocclusion associated with traumatic occlusion
  • Teeth with calcified canals
  • Teeth with periapical radiolucency
  • Teeth with root resorption
  • Teeth previously undergone root canal treatment

研究组 & 干预措施

Group A

Experimental

Manual Dynamic Agitation Group: Irrigation in this group shall be done using a master gutta percha cone during root canal therapy

干预措施: Manual Dynamic Agitation (Device)

Group B

Experimental

Passive Ultrasonic Activation Group: In this group, final activation during endodontic therapy shall be done using an ultrasonic activation device (Ultra X)

干预措施: Passive Ultrasonic Activation (Device)

结局指标

主要结局

Post Operative pain assessed by VAS after endodontic therapy

时间窗: 1 week

comparative evaluation of post operative pain after using different irrigation devices, using VAS (Visual Analog Scale). It is drawn as a straight line of 10 inches and marked in numbers which show intensity of pain, from 0-10, with 0 being no pain at all to10 being the worst pain imaginable. In detail, it is a scale which shows pain intensity in ascending order and can also be used to analyze the intensity of pain experienced by the patient. 0: No pain at all 1-3: mild pain 4-6: moderate pain 7-9: severe pain 10: worst pain imaginable

次要结局

未报告次要终点

研究者

发起方
Armed Forces Institute of Dentistry, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Abdullah

Registrar Operative Dentistry and Endodontics

Armed Forces Institute of Dentistry, Pakistan

研究点 (2)

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