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临床试验/NCT06400030
NCT06400030已完成不适用

The Effects of BioCeramic Sealer With Single Cone Technique on the Healing of Periapical Lesions: A Randomized Controlled Trial

Damascus University2 个研究点 分布在 2 个国家目标入组 41 人开始时间: 2020年6月22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
41
试验地点
2
主要终点
Change in the periapical lesion diameter

研究概览

简要总结

This clinical study will evaluate the effect of BioCeramic sealer with single cone compared with the control group treated with AH Plus with lateral condensation in root canal obturation on the healing of periapical lesions.

The study sample will consist of 41 patients with 65 teeth with clear periapical lesions.

Root canal obturation will be applied for all patients. BioCeramic sealer will be applied for the experimental group only.

The changes of the dimensions of the periapical lesion will be assessed using CBCT radiographs; pre- and post- treatment changes for each group will be evaluated individually.

详细描述

Periapical lesions is considered as the most common symptoms associated with infected root canals.

Recently, the BioCeramic sealer has been considered one of the most common endodontic sealer that possess antibacterial properties, so it can have an effective role in the healing of periapical lesions, as well as its ability to prevent periapical leakage due to its attachment to the dentinal walls and gutta-percha cones.

This study will evaluate the effect of BioCeramic sealer on the healing of periapical lesions and the changes of the dimensions of the lesions.

Root canal obturation with gutta-percha cones will be applied in the two groups: The control group will receive the AH Plus with lateral condensation technique, and the experimental group will receive BioCeramic sealer with single cone technique.

CBCT radiographs will be gotten before and after one year of the treatment to evaluate the periapical lesion dimensions changes.

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
None

入排标准

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

入选标准

  • One maxillary anterior tooth with a clear periapical lesion at least.
  • Normal anatomic features and straight or slightly curved roots.
  • The treated teeth must have complete roots and a closed apex.
  • The ability to isolate the teeth with a rubber dam and restore them.
  • Good oral hygiene.
  • Good systemic health.

排除标准

  • Root caries.
  • Root fractures or resorption.
  • Signs of occlusal trauma on the treated tooth.
  • Internal or external resorption.
  • Active periodontal disease.
  • Pregnancy or lactation.

结局指标

主要结局

Change in the periapical lesion diameter

时间窗: before and after one year of the treatment (root canal obturation)

This diameter of the periapical lesions is going to be measured on a CBCT image. Initially, the sections of the periapical lesions will be evaluated in the three planes (sagittal, coronal, and axial). The section that contains the largest area of the lesion in each studied plane, will be used for measurement. * If the shape of periapical lesion is circular, the periapical diameter would be taken (at this plane) relying on the scale in the program accompanying the radiograph (CBCT). * If the shape of periapical lesion is not circular, the largest and smallest diameter of the lesion will be taken (at this plane) depending on the scale in the program accompanying the CBCT image, then the mean diameter will be calculated by collecting the previous two diameter and dividing them by 2. Ultimately, the three diameters of the lesion (taken at the three planes) are collected and the total is divided into 3 to obtain the mean diameter of the lesion.

次要结局

  • Change in the presence of edema(before, after six months, and one year of the treatment (root canal obturation))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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