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临床试验/NCT03795636
NCT03795636已完成不适用

Allium Sativum Extract as an Irrigant in Pulpectomy of Primary Molars: 12 Month In-vivo Study

Minia University0 个研究点目标入组 91 人开始时间: 2016年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
91
主要终点
oral examination

研究概览

简要总结

Garlic extract as herbal compound has potent antibacterial properties and can be used safely as an irrigant for pulpectomy procedure of primary molars root canals with high clinical and radiographic outcomes

详细描述

Aim: This study indented to assess the clinical and radiographic assessment of garlic extract as an intracanal irrigant for pulpectomy of primary molars.

Methodology: 91 child with 100 teeth submitted into this study were equally categorized into the test group (group 1) which irrigated with garlic extract and control group (group 2) that received sodium hypochlorite (NaOCl). Then, each group has been subjected to further specification according to the tooth preoperative clinical and radiographic features into has been into 2 subgroups. Clinical and radiographic success rates were checked at 3, 6 and 12 months. Fisher's exact test for binary variable was used for data analysis with p-value ≤ 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 (Participant, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Class I or II according to American Society of Anesthesiologists (ASA)
  • Irreversible pulpititis recognised through; (1) profuse bleeding from root canal orifices after complete debridement of coronal pulp tissue and cannot be dominated by moist cotton pellet. (2) History of lingered thermal pain spontaneous nocturnal pain
  • Necrotic pulp tissues which may be asymptomatic or manifested with dull ache pain
  • Pathological tooth mobility
  • Percussion sensitivity
  • Swelling close to involved tooth accompanied with or without fistula Radiographic characteristics of the root and supporting structures
  • Normal radiographic findings
  • Interruption of lamina dura
  • Furcation radiolucency

排除标准

  • Specifications of exclusion
  • Uncooperativeness of child and/or parents or caregivers behavior
  • Unrestorable tooth
  • Presence of internal root resorption
  • Presence of calcific metamorphosis inside root canals
  • Presence of root resorption exceeding one third of its length

研究组 & 干预措施

Garlic extracts root canal irrigation group

Experimental

Experimental group treated with garlic extract

A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water

干预措施: Garlic extract (Other)

Sodium hypochlorite root canal irrigation group

Active Comparator

Control group which treated conventionally using .5 ml of 5.25% NaOCl (COLTENE®ENDO, Switzerland)

干预措施: NaOCl (COLTENE®) (Other)

结局指标

主要结局

oral examination

时间窗: 12 months

Pain assessment using Visual Analog Score for pain

radiographic success or failure

时间窗: 12 months

Radiographic assessment using periapical radiograph and score (0) applied for absence of radiolucency and score (1) for presence of radiolucency

次要结局

  • Types of failures(12 months)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmad Elheeny

Lecturer of pediatric dentistry

Minia University

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