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临床试验/NCT05376033
NCT05376033已完成不适用

Outcome of Root Canal Treatments Obturated With Calcium Silicate Based Sealers

University of Bologna2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
109
试验地点
2
主要终点
Healing rate

研究概览

简要总结

The clinical use of a flowable premixed calcium-silicate bioceramic sealer used in association with warm carrier-based/single-cone technique will be compared with epoxy resin-based sealer with carrier-based technique.

详细描述

Healthy consecutive patients (n= 109) requiring 141 root canal treatments were enrolled in this study and divided in 3 groups (Group 1: Ceraseal + single cone cold technique n=47. Group 2: Ceraseal + Carrier-based technique n=47. Group 3 AH Plus + Carrier based technique n=47).

Periapical X-rays were taken preoperatively, after root canal filling and after 6, 12 and 24 months. Two evaluators blindly assessed the Periapical Index (PAI) and sealer extrusion in the 3 groups (k =0.90). Healing rate and survival rate were also analysed.

Chi square tests was used to analyse significant differences among the groups. Multilevel analysis was performed to analyse the factors associated to healing status and survival status.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-75 years
  • no use of antiresorptive or antiangiogenic drug
  • healthy status (ASA 1 or 2).
  • Needing one or more root canal treatment

排除标准

  • Teeth with less than 2 walls of structural integrity
  • Wide apexes (>40 diameter)
  • Any pathology that could compromise bone healing or the immune response,
  • pregnancy or breast feeding
  • heavy smoking (>15 cigarettes/day), (Tverdal & Bjartveit 2006)
  • exposure to radiation therapy focussed on the head and neck region and malignant disease directly involving the jaws.
  • Lacks of occlusal contacts

结局指标

主要结局

Healing rate

时间窗: 24 months

Periapical index minor than 3 at the endline

次要结局

  • Survival rate(24 months)

研究者

发起方
University of Bologna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fausto Zamparini

University of Bologna

University of Bologna

研究点 (2)

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