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临床试验/NCT04197531
NCT04197531已完成不适用

A Comparative Evaluation of the Effect of EndoActivator and Endodontic Syringe Usage on Postoperative Pain in Root Canal Irrigations in Primary Molar Teeth: A Randomized Clinical Study

TC Erciyes University2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
2
主要终点
Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 72th hours

研究概览

简要总结

This study was to evaluate and compare the postoperative pain levels after using EndoActivator and conventional endodontic syringe irrigation in root canal therapy of primary molars.

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
Single (Participant)

入排标准

年龄范围
5 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients exhibiting positive or definitely positive behavior on the Frankl's behavior rating scale (rating 3 or 4 on the Frankl's scale)
  • American Society of Anesthesiologists class 1 patients aged 5-9 years
  • Patients with symptomatic irreversible pulpitis of maxillary primary molars confirmed using periapical radiographs, percussion, and cold test
  • Patients having teeth with two-thirds of each root remaining
  • Absence of periapical lesions and interradicular radiolucency
  • Moderate to very severe (2-4) five-face scale pain scores in the 24-hour period before the procedure.

排除标准

  • Patients who had taken analgesics and antibiotics within the last 12 hours before root canal treatment
  • Teeth with pathologic root resorption
  • Teeth with excessive mobility.

结局指标

主要结局

Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 72th hours

时间窗: 72th hours

Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.

Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 8th hours

时间窗: 8th hours

Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.

Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 24th hours

时间窗: 24th hours

Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.

Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 48th hours

时间窗: 48th hours

Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.

次要结局

  • Analgesic intake comparison after root canal treatment with two different irrigation methods at 0-8 hours.(0-8 hours)
  • Analgesic intake comparison after root canal treatment with two different irrigation methods at 8-24 hours.(8-24 hours)
  • Analgesic intake comparison after root canal treatment with two different irrigation methods at 24-48 hours.(24-48 hours)
  • Analgesic intake comparison after root canal treatment with two different irrigation methods at 48-72 hours.(48-72 hours)

研究者

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

Husniye Gumus

Study Director, PHD., Dr.

TC Erciyes University

研究点 (2)

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