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Comparing Amla (Emblica Officinalis) and 3% Sodium Hypochlorite Against Enterococcus Faecalis in Root Canal Treatment: A Randomized Controlled Trial

2026年6月30日 更新者:Dr Afshan Afzal Wahla、Postgraduate Medical Institute, Lahore

"Comparative Antibacterial Evaluation of Emblica Officinalis and 3% Sodium Hypochlorite, Against Enterococcus Faecalis, as Root Canal Irrigants in Non-surgical Root Canal Treatment of Mature Single Rooted Anterior Teeth - A Randomized Controlled Trial."

Bacteria inside the root canal are a major cause of tooth infections. If they are not completely removed, the infection may continue even after root canal treatment. One bacterium, Enterococcus faecalis, is commonly found in persistent root canal infections. The goal of root canal treatment is to remove these bacteria and prevent the infection from returning. Along with cleaning the canal using dental instruments, dentists use disinfecting solutions (called irrigants) to kill remaining bacteria.

The most commonly used irrigant is 3% sodium hypochlorite. Although it is effective at killing bacteria, it can irritate tissues, cause allergic reactions, has an unpleasant smell and taste, and may weaken the tooth. Because of these disadvantages, researchers are exploring safer natural alternatives. Amla (Emblica officinalis) is a medicinal plant known for its antibacterial, anti-inflammatory, and pain-relieving properties. This study aims to compare amla with 3% sodium hypochlorite to determine how well each reduces Enterococcus faecalis during root canal treatment and whether they produce similar clinical outcomes.

The study will include 66 patients aged 14-50 years who require root canal treatment for an infected single-rooted front tooth. Participants will be randomly assigned to one of two groups: one will receive 3% sodium hypochlorite, and the other will receive amla as the root canal irrigant. Bacterial samples will be collected before treatment, immediately after cleaning the canal, and one week later. The number of bacteria will be measured and compared between the two groups. The researchers will also assess pain, tenderness, and other signs of healing after treatment. The findings will help determine whether amla is a safe and effective natural alternative to the standard root canal irrigant.

研究概览

详细说明

The primary objective of endodontic therapy is the complete elimination of microorganisms from the root canal system. Successful root canal treatment (RCT) depends on effective cleaning, shaping, and disinfection of the root canal system. During canal preparation, the removal of bacterial toxins and the smear layer is essential to minimize the microbial load. However, because bacteria and dentinal debris may remain within the complex anatomy of the root canal system, mechanical instrumentation alone is often insufficient to achieve complete disinfection. Elimination of the infection before obturation is critical for improving treatment success and promoting periapical healing.

Enterococcus faecalis is one of the microorganisms most frequently associated with persistent root canal infections and endodontic treatment failure. It is a facultative anaerobic, Gram-positive coccus capable of surviving under harsh environmental conditions. E. faecalis can persist in nutrient-deprived environments, exhibits resistance to several intracanal medicaments, and tolerates alkaline conditions with a pH of up to 11.5, making it particularly difficult to eradicate.

To enhance microbial elimination, root canal preparation is routinely supplemented with irrigating solutions. Sodium hypochlorite (NaOCl) is the most widely used endodontic irrigant because of its broad-spectrum antimicrobial activity and tissue-dissolving properties. It is commonly used in concentrations ranging from 0.5% to 5.25%. Although NaOCl is considered the gold standard irrigant, higher concentrations are associated with increased cytotoxicity, tissue irritation, and caustic effects. Accidental extrusion beyond the root apex may result in severe damage to the surrounding periodontal and periapical tissues.

In view of these limitations, there is growing interest in identifying natural irrigants that provide effective antimicrobial activity with fewer adverse effects. Emblica officinalis (Amla) is a medicinal plant with well-documented antibacterial, anti-inflammatory, antioxidant, and analgesic properties. It has been widely used in traditional medicine and is rich in vitamin C and other bioactive compounds. Several in vitro studies have demonstrated significant antibacterial activity of Emblica officinalis against Enterococcus faecalis. In addition, it is inexpensive, readily available, and has no reported toxicity when used appropriately.

The present randomized controlled trial aims to compare the antibacterial efficacy of Emblica officinalis with 3% sodium hypochlorite as root canal irrigants during non-surgical root canal treatment of mature single-rooted anterior teeth with pulp necrosis and apical periodontitis. Antibacterial efficacy will be assessed by measuring bacterial colony-forming units (CFU/mL), and clinical outcomes will be evaluated by assessing pain on percussion, tenderness on palpation, and the presence of a sinus tract following treatment.

研究类型

介入性

注册 (估计的)

66

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Punjab Province
      • Lahore、Punjab Province、巴基斯坦、54000
        • Punjab Dental Hospital, Lahore

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Co-operative patients of both sexes aged between 18-50 years
  • Patients belonging to ASA classification I and II (mild to moderate systemic disease).
  • Permanent mature single-rooted and single canal teeth.
  • Patients with pulp necrosis / apical periodontitis (primary endodontic infection with periapical radiolucency) will be included.
  • Adequate crown structure.
  • Probing level </= 3mm
  • Patients not taking antibiotics for the last two weeks (pragmatic approach).

Exclusion Criteria:

  • ●Patients with ASA Classification III, IV, V and VI or any other congenital disease.

    • Patient with liver failure and patient on blood thinning medication will be excluded.
    • Teeth with Multiple roots and canals.
    • Teeth with calcified pulp chamber.
    • Teeth with previous endodontic therapy performed.
    • Aberrant anatomy.
    • Teeth associated with vertical root fracture and coronal perforation.
    • Patient taking antibiotics in the last two weeks.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:3% Sodium Hypochlorite Irrigation ( Control)
Participants assigned to this arm will undergo non-surgical root canal treatment using 3% sodium hypochlorite as the root canal irrigant. Following access cavity preparation and working length determination, the root canal will be instrumented using K-files. A total of 6 mL of 3% sodium hypochlorite will be used for irrigation during canal preparation and shaping. Microbiological samples will be collected before instrumentation (S1), immediately after instrumentation and irrigation (S2), and one week later (S3) to evaluate the reduction in Enterococcus faecalis colony-forming units (CFU/mL). Clinical outcomes, including pain on percussion, tenderness on palpation, and the presence of a sinus tract, will also be assessed.
A total of 6 mL of 3% sodium hypochlorite will be used as the root canal irrigant during cleaning and shaping in non-surgical root canal treatment.
实验性的:Emblica officinalis (Amla) Irrigation (Experimental)
Participants assigned to this arm will undergo non-surgical root canal treatment using Emblica officinalis (Amla) as the root canal irrigant. Following access cavity preparation and working length determination, the root canal will be instrumented using K-files. A total of 6 mL of Emblica officinalis solution will be used for irrigation during canal preparation and shaping. Microbiological samples will be collected before instrumentation (S1), immediately after instrumentation and irrigation (S2), and one week later (S3) to evaluate the reduction in Enterococcus faecalis colony-forming units (CFU/mL). Clinical outcomes, including pain on percussion, tenderness on palpation, and the presence of a sinus tract, will also be assessed.
A total of 6 mL of Emblica officinalis (Amla) solution will be used as the root canal irrigant during cleaning and shaping in non-surgical root canal treatment.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Reduction in Enterococcus faecalis bacterial count (CFU/mL)
大体时间:Baseline, immediately after irrigation, and 7 days after treatment.
Change in the number of Enterococcus faecalis colony-forming units (CFU/mL) recovered from root canal samples collected before treatment, immediately after irrigation, and 7 days after treatment, comparing 3% sodium hypochlorite and Emblica officinalis irrigation.
Baseline, immediately after irrigation, and 7 days after treatment.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2026年8月1日

研究完成 (估计的)

2026年9月1日

研究注册日期

首次提交

2026年6月30日

首先提交符合 QC 标准的

2026年6月30日

首次发布 (实际的)

2026年7月7日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年6月30日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Undecided Confidentiality

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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