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临床试验/NCT05399303
NCT05399303已完成不适用

Pain Evaluation After Single Visit Nonsurgical Retreatment Using a Bio Ceramic Sealer

Misr International University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1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
100
试验地点
2
主要终点
Visual analogue scale (VAS)

研究概览

简要总结

Postoperative pain in endodontic retreatment cases presents a challenge to any endodontist. Tricalcium silicate materials as mineral trioxide aggregate (MTA) and bioceramics have shown favorable periapical tissue reactions and healing when used as part of the root canal filling material. This study was conducted to compare the difference in the postoperative pain when resin cements are used versus bioceramic cements in the obturation of root canals.

详细描述

The Faculty of Dentistry Ain Shams University's Research Ethics Committee reviewed the current proposal for ethical approval. One hundred patients with permanent molar teeth requiring endodontic non-surgical retreatment were treated in this study. Teeth with fractured instruments were excluded. Patient ages ranged from twenty to fifty years, both men and women were treated in the current study. Infants, children, people unable to take decisions, university students, orphans, mentally or physically disabled patients were excluded from the current study.

Preoperative assessment of the degree of the patient's pain was done using the visual analog scale. Fifty teeth were obturated with gutta percha using the epoxy resin-based sealer (AH Plus) as the control group, and in the other fifty bioceramic based cement (Endosequence) was used. All teeth were prepared by the protaper next rotary files (Dentsply Sirona) under copious irrigation with 30ml of 2.6 % sodium hypochlorite throughout the procedure. Ethylamine diamine tetracetic acid (EDTA) 17% was used to remove the smear layer before the obturation commenced. Obturation was done using the cold lateral compaction technique in the resin group and single cone technique in the bioceramic group. Postoperative pain assessment was done for each patient after six hours, twenty-four hours, four days and one week.

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Mandibular molars with fully formed roots that need retreatment.
  • Age range 20 - 50 years.
  • Teeth having a baseline periapical lesion (PAI score ≥2) in the affected root.

排除标准

  • • Patients with separated files that need to be retrieved or bypassed.
  • Pregnant females.
  • Patients suffering from a systemic disease.
  • Teeth with lesions connected to adjacent teeth.
  • Teeth with root fractures or perforations.
  • Teeth with lesions communicating with the alveolar crest.
  • Patients with generalized chronic periodontitis or teeth that need periodontal surgery prior to coronal restorations due to marginal deficiency
  • Teeth with damaged or resorbed peri- apex
  • Teeth that were treated with a fiber post and teeth with canal curvature more than 30 degrees.

结局指标

主要结局

Visual analogue scale (VAS)

时间窗: one week

Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

次要结局

未报告次要终点

研究者

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

Ahmed Ghobashy

associate professor

Misr International University

研究点 (2)

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