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临床试验/NCT03278054
NCT03278054已完成不适用

Effect of Different Instrumentation Technique on Outcome of Primary Non Surgical Endodontic Treatment

Postgraduate Institute of Dental Sciences Rohtak0 个研究点目标入组 90 人开始时间: 2015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
入组人数
90
主要终点
Radiographic success

研究概览

简要总结

Aim: To evaluate and compare the outcome of primary endodontic treatment following use of different instrumentation techniques.

Materials and methods: Study subjects were recruited from the pool of patients referred for the non-surgical root canal treatment in the Department of Conservative Dentistry & Endodontics at PGIDS, Rohtak (Haryana).

The study population comprised of patients requiring primary root canal treatment following the diagnosis of pulpal necrosis with chronic apical periodontitis in mature mandibular first and second molars.

Subjects were allocated to one of the three study groups: manual instrumentation, ProTaper instrumentation and Hybrid instrumentation.

详细描述

AIMS AND OBJECTIVES

The present study has been designed with the following aims and objective:

  • To evaluate the effect of manual / rotary/hybrid instrumentation techniques on success of primary non surgical root canal treatment in teeth with apical periodontitis.
  • To assess the incidence of postoperative pain in teeth treated with and without rotary instrumentation.
  • To compare manual, rotary and hybrid instrumentation techniques in terms of periapical healing in teeth with apical periodontitis.

METHODOLOGY

Prior to treatment a thorough clinical and radiological examination was carried out. A thorough history was taken from each patient. Prior informed consent was taken after explaining the procedure, risks and benefits.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient willing to participate in the study.
  • Age greater than 18 years.
  • No history of antibiotic use prior to treatment.
  • Mature permanent mandibular molar having apical periodontitis requiring primary root canal treatment.
  • There must be a radiographic evidence of periapical radiolucency and a diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber.

排除标准

  • Root canal retreatment.
  • Failure to obtain authorization from patients.
  • The presence of a difficult canal anatomy, internal or external resorption and immature teeth.
  • Accident or complication during treatment like calcified canals, inability to achieve apical patency in any canals.
  • Immuno-compromised, diabetic, pregnant and hypertensive patients.
  • Periodontally compromised teeth.

研究组 & 干预措施

Manual group

Active Comparator

Root Canal Treatment with hand instruments:Root canal treatment was done with instrumentation using manual K files.

干预措施: Root Canal Treatment with hand instruments (Other)

ProTaper group

Active Comparator

Root canal treatment with Protaper instruments:Root canal treatment was done using ProTaper rotary files S1, S2, F1, and F2.

干预措施: Root canal treatment with Protaper instruments (Other)

Hybrid group

Active Comparator

Root canal treatment with hybrid instrumentation:Root canal treatment was carried out using ProTaper and Hyflex CM files.

干预措施: Root canal treatment with hybrid instrumentation (Other)

结局指标

主要结局

Radiographic success

时间窗: till 12 month period

Periapical radiolucency was graded as Periapical Index (PAI) and scores less than 3 were grded as success

Clinical success

时间窗: 12 months

Absence of pain tenderness sinus or swelling was graded as clinical success

次要结局

  • Pain intensity(every 24 hours for 7 days)

研究者

申办方类型
Other
责任方
Sponsor

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