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临床试验/NCT05050071
NCT05050071已完成2 期

Comparative Evaluation of Antibacterial Effect of Allium Sativum, Calcium Hydroxide and Their Combination as Intracanal Medicaments in Infected Mature Teeth. A Randomized Control Trial

Suez Canal University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年10月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
48
试验地点
1
主要终点
Test the antibacterial efficiency of Garlic extract as intracanal medicament in comparison to Calcium hydroxide and their combinations , against E.faecalis and streptococcus bacteria using qRT-PCR analysis.

研究概览

简要总结

This study was to evaluate and compare garlic extract antibacterial effect when used as an intra-canal medicament in infected mature anterior teeth with calcium hydroxide and a mixture of calcium hydroxide and garlic, using real time PCR analysis.

详细描述

Sixty-six permanent mature necrotic incisors associated with apical periodontitis in male children were selected. Teeth were randomly divided into three groups (n=22) according to intra canal medications used; group I: Ca OH2, group II: garlic extract and group III: mixture of Ca OH2 and garlic extract. After access preparation, four microbiological samples (S) were taken using sterile absorbent paper points as follows; (S1): were taken before canal instrumentation and irrigation. (S2): after cleaning and shaping, Then, the third samples (S3) and forth samples (S4) were taken after placement of the tested intracanal medications into the corresponding canals, for 7 and 14 days respectively. Total DNA was extracted from microbiological samples and relative quantitive real time PCR reactions were done to quantify the relative gene expression levels (FC) for Streptococcus and Enterococcus faecalis species. Data was statistically analyzed using Kruskal-Wallis and Freidman's tests, followed by Mann-Whitney and Wilcoxon singed rank tests at significance level p ≤ 0.05.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 13 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Cooperative male children with age ranging from 10 to 13 years.
  • All patients should have pulp necrosis with apical periodontitis in one or more upper incisor(s).
  • Teeth included in the study were preliminarily evaluated by preoperative periapical radiographs and should have: single canal (type I vertucci's classification) with closed apices, periapical lesions of endodontic origin with a diameter ranging from 2 to 5 mm without any previous RCT procedure.

排除标准

  • immune-compromised patient or patient with complicating systemic disease.
  • Patients received antibiotic therapy within the previous 3 months.
  • Tooth having gross carious lesions, fractures or cracks involving the periodontium (un-restorable tooth).
  • Tooth with root canal calcifications or resorption
  • 6- Tooth with periodontal pockets of more than 4 mm depth, with or without endo-perio communication either concomitant or combined.

研究组 & 干预措施

Calcium hydroxide (7 days)

Active Comparator

is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime

干预措施: Allium Sativum (Drug)

Calcium hydroxide (7 days)

Active Comparator

is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime

干预措施: Polymerase chain reaction (Device)

Allium sativum (7 days)

Experimental

is a species of bulbous flowering plant in the onion genus Allium

干预措施: Allium Sativum (Drug)

Allium sativum (7 days)

Experimental

is a species of bulbous flowering plant in the onion genus Allium

干预措施: Polymerase chain reaction (Device)

Combination (7 days)

Experimental

combination between Calcium hydroxide and Allium sativum

干预措施: Allium Sativum (Drug)

Combination (7 days)

Experimental

combination between Calcium hydroxide and Allium sativum

干预措施: Polymerase chain reaction (Device)

Allium sativum (14 days)

Experimental

is a species of bulbous flowering plant in the onion genus Allium

干预措施: Polymerase chain reaction (Device)

Calcium hydroxide (14 days)

Active Comparator

is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime

干预措施: Allium Sativum (Drug)

Calcium hydroxide (14 days)

Active Comparator

is also known as slaked lime or calcium hydrate. It is produced by the hydration of lime

干预措施: Polymerase chain reaction (Device)

Allium sativum (14 days)

Experimental

is a species of bulbous flowering plant in the onion genus Allium

干预措施: Allium Sativum (Drug)

Combination (14 days)

Experimental

combination between Calcium hydroxide and Allium sativum

干预措施: Allium Sativum (Drug)

Combination (14 days)

Experimental

combination between Calcium hydroxide and Allium sativum

干预措施: Polymerase chain reaction (Device)

结局指标

主要结局

Test the antibacterial efficiency of Garlic extract as intracanal medicament in comparison to Calcium hydroxide and their combinations , against E.faecalis and streptococcus bacteria using qRT-PCR analysis.

时间窗: 12 months

The change in the mean relative gene expression (bacterial load), for E.faecalis and streptococcus species was measured using quantitative real time polymerase chain reaction (qRT-PCR) after placement garlic (Allium Sativum), Calcium hydroxide and their combinations for one week, in infected single rooted anterior teeth. Statistical analysis was done to compare between the tested medicaments

次要结局

  • Test the antibacterial effect of increasing the contact time (14 days) for garlic (Allium Sativum), Calcium hydroxide or their combinations inside infected root canals, against E.faecalis and streptococcus bacteria using qRT-PCR analysis.(12 months)

研究者

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

Reham Mohamed

Principle Investigator

Suez Canal University

研究点 (1)

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