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临床试验/NCT06759766
NCT06759766尚未招募不适用

Evaluation of Antimicrobial Potency of Garlic Lemon Extract Irrigant Versus Physiological Saline Irrigant Following Partial Pulpectomy in Primary Molars: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 38 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
38
主要终点
bacterial count

研究概览

简要总结

To evaluate the antimicrobial potency of Garlic Lemon extract irrigant versus physiological saline irrigant following partial pulpectomy in primary molars.

详细描述

Pulpectomy is a suitable treatment of primary teeth with irreversible pulpitis, necrosis, or periodontitis due to caries or trauma. Due to the complex nature of the deciduous root canal system makes total removal of necrotic tissue by instrumentation alone impossible. Therefore, irrigation is a replenishing step to create a disinfectant atmosphere inside the root canal.

A variety of antiseptic and antibacterial irrigating solutions have been used such as (NaOCl), (CHX), and (EDTA). Due to their adverse effects, safety issues and cytotoxic reactions, Herbal products can be an alternative to these irrigants based on their previous history in medical field.

Herbal extracts such as garlic (Allium sativum) Shows a wide range of therapeutic effects due to the presence of allicin, ajoene & other thiosulfinates. It has antibacterial effect against wide range of gram-positive and gram-negative bacteria, anti-inflammatory, antioxidant, antiviral, antifungal, antitumor, immunomodulatory effects and tissue-dissolving capacity (Siddique, et al., 2020). According to (Elheeny., 2019) Allium sativum extract can be used efficiently as an irrigant for pulpectomy of primary molar root canals.

Lemon (Citrus Limon) as well has curative properties such as, antibacterial, antiviral, antifungal, anti-inflammatory, anti-cancerous activities and removal of the smear layer as well. Due to presence of ascorbic acid, phenolic acids, polyphenols, and dietary fibers.

the combination of Garlic-Lemon has been tested in adult teeth as an irrigant and showed an effective result equal to NaOCl (Siddique, et al., 2020).However, there is no studies have been performed to assess the combination of Garlic-lemon extract as an irrigant in deciduous molars.

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 (Participant, Outcomes Assessor)

盲法说明

The blinding of operator is not possible due to the nature of the material used. The clinical outcome assessor and statistician will be blinded in this study.

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •The children's age range from four to seven years from both sexes.
  • •Presence of localized swelling, sinus and pain on percussion which indicate non vital pulp.
  • •Presence of periapical and furcation radiolucency in periapical radiograph.
  • •Absence of history of systemic disease which would contraindicate pulp therapy e.g. infective endocarditis.
  • •No previous history of antibiotics administration or last dose was taken from at least two weeks.

排除标准

  • •Presence of advanced physiologic or pathologic root resorption in X-ray.
  • •Uncooperative children.
  • •Teeth with unrestorable crowns.
  • •Teeth with abnormal anatomy and calcified canals.

研究组 & 干预措施

Garlic-Lemon Extract irrigant

Active Comparator

garlic (Allium sativum) Shows a wide range of therapeutic effects due to the presence of allicin, ajoene & other thiosulfinates. It has antibacterial effect against wide range of gram-positive and gram-negative bacteria, anti-inflammatory, antioxidant, antiviral, antifungal, antitumor, immunomodulatory effects and tissue-dissolving capacity (Siddique, et al., 2020). According to (Elheeny., 2019) Allium sativum extract can be used efficiently as an irrigant for pulpectomy of primary molar root canals.

Lemon (Citrus Limon) as well has curative properties such as, antibacterial, antiviral, antifungal, anti-inflammatory, anti-cancerous activities and removal of the smear layer as well. Due to presence of ascorbic acid, phenolic acids, polyphenols, and dietary fibers.

the combination of Garlic-Lemon has been tested in adult teeth as an irrigant and showed an effective result equal to NaOCl (Siddique, et al., 2020).

干预措施: Garlic-Lemon Extract irrigant (Combination Product)

physiological saline irrigant

Active Comparator

Normal saline solution exhibits no adverse effects on the developing successors; Serves primarily to facilitate root canal cleaning during the irrigation process, in comparison to other commercial synthetic irrigants such as Sodium hypochlorite (NaOCl), Chlorhexidine (CHX), Ethylenediamine tetra acetic acid (EDTA) which exhibit potential side effects and cytotoxic reactions (Sayadizadeh et al., 2019).

干预措施: physiological saline (Other)

结局指标

主要结局

bacterial count

时间窗: pre and after irrigation within the same visit

colony forming unit (CFU) quantitative measure

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

Nourhan Yasser Yousef Mohamed

principle investigator

Cairo University

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