跳至主要内容
临床试验/NCT04145102
NCT04145102已完成不适用

Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019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
80
试验地点
2
主要终点
Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin

研究概览

简要总结

The present study will be performed to evaluate:

  1. The remineralizing effect of natural materials versus synthetic materials on deep carious dentin after selective caries removal.
  2. The antibacterial effect of natural materials versus synthetic materials on deep carious dentin.

详细描述

This study will be conducted on 64 teeth selected from patients according to inclusion and exclusion criteria. They will be selected from the dental clinic in faculty of dental medicine, Al-Azhar University. The procedure will be explained and written informed consent will be obtained from each patient. The possible discomforts, risks, and benefits will be fully explained to the patients. Ethical committee approval will be obtained.

Protocol of caries removal will be removed Subsequently, the central cariogenic biomasses and superficial part of the necrotic and demineralized dentin will be then excavated, leaving the last carious affected dentin layer.

Sample grouping:

The patients will be randomly assigned into four main groups according to the material used (16 for each) then each group will be subdivided into two subgroups (n=8) according to time of treatment (B1) after one month,(B2) after three month.

A1: cavities will be treated by propolis extract then sealed directly by temporary conventional glass ionomer.

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, Investigator)

入排标准

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

入选标准

  • Subject must have active deep carious lesion.
  • clinical and radiographic examinations of carious lesions.

排除标准

  • Teeth with pulpal involvement
  • Teeth with abscess
  • Teeth with pain or swelling
  • Teeth with developmental disorders
  • Teeth with adjacent soft tissue lesions
  • patients with systemic illness will be excluded

结局指标

主要结局

Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin

时间窗: antibacterial and reminerlizing effect will be evaluated after three monthes

antibacterial effect will be evaluated by bacterial count at base line and after three months reminerliazation effect will be evaluated by radiographes

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

Dalia Mohamed Elasser

Doaa Elsharkawy,Assistant Professor of operative department

Al-Azhar University

研究点 (2)

Loading locations...

相似试验