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临床试验/NCT03792217
NCT03792217已完成不适用

Postoperative Pain After Endodontic Irrigation Using 1.3% Versus 5.25% Sodium Hypochlorite

Cairo University0 个研究点目标入组 308 人开始时间: 2011年7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
308
主要终点
Postoperative pain using a pain-measuring scale

研究概览

简要总结

The aim of this prospective, randomized, clinical trial was to evaluate the effect of 1.3% sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative pain and medication intake in adult patients with pulp necrosis in mandibular molars.

详细描述

The aim of this prospective, randomized, clinical trial was to evaluate the effect of 1.3% sodium hypochlorite (NaOCl) concentration versus 5.25% NaOCl concentration on post-operative pain and medication intake in adult patients with pulp necrosis in mandibular molars. Medical and dental history was obtained from all participants in this trial and clinical and radiographic evaluation for teeth was recorded. Participants with pulp necrosis with or without apical periodontitis were included. After access cavity preparation, participants were randomly assigned to one of the following groups: experimental group (irrigation using 1.3% NaOCl) or control group (irrigation using 5.25% NaOCl ). Two-visit root canal treatment was performed with a week interval in between visits. Each patient received a 7-day diary to record postoperative pain and rescue medication intake. Post-operative pain was measured at the following time points: immediately , 3, 24, 48 hours and 7 days after the first visit and postobturation.

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)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age: 25-45 year old.
  • •Medically free.
  • •Non-vital mandibular teeth (first or second molar) with or without apical periodontitis
  • •No sex predilection

排除标准

  • •Pregnant females.
  • •History of allergy to any medication used in the study.
  • •Preoperative premedication 12 hours before procedure.
  • •Acute abscess cases.
  • •Badly-decayed crown.
  • •Retreatment cases

研究组 & 干预措施

1.3% NaOCl

Experimental

Root canal irrigation done using 1.3% NaOCl.

干预措施: 1.3% NaOCl (Other)

5.25% NaOCl

Active Comparator

Root canal irrigation done using 5.25% NaOCl.

干预措施: 5.25% NaOCl (Other)

结局指标

主要结局

Postoperative pain using a pain-measuring scale

时间窗: immediately after obturation

Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured immediately after obturation.

Postoperative pain using a pain-measuring scale

时间窗: immediately after treatment

Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured immediately after the first visit

Postoperative pain using a pain-measuring scale

时间窗: 3 hours

Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 3 hours after the first visit

Postoperative pain using a pain-measuring scale

时间窗: 24 hours

Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the first visit

Postoperative pain using a pain-measuring scale

时间窗: 48 hours

Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the first visit

Postoperative pain using a pain-measuring scale

时间窗: 7 days

Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 7 days after the first visit

次要结局

  • Sham medication intake incidence(7 days)
  • Analgesic medication intake incidence(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzan AW Amin

Professor

Cairo University

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