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临床试验/NCT04903808
NCT04903808Unknown2 期

Clinical And Cost- Effectiveness of Allium Sativum Oil Versus Mineral Trioxide Aggregate in Primary Molars Pulpotomy in Group of Egyptian Children : A Randomised Clinical Pilot Study.

Cairo University0 个研究点目标入组 26 人开始时间: 2021年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
26
主要终点
Clinical effectiveness

研究概览

简要总结

Allium Sativum oil is advocated to prove the capability of new natural products in replacing higher cost pharmacological materials, while achieving the same successful clinical and radiographic long-term results.

详细描述

One of the most challenging subjects in paediatric dentistry is choosing the ideal pulp medication material that has the required properties such as preserving the vitality of the remaining intact pulp and stimulating its repair. This material should prevent pathological root resorption.Clinical and cost effectiveness trials from different countries are useful to determine which medicament should be advocated in which economic setting . Alternative pulpotomy materials clinically effective as MTA but with lower cost should be studied .

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

participants and outcome assessor will be blinded (double blind study )

入排标准

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

入选标准

  • Apparently healthy children aged from 5- 7 years.
  • Children not having antibiotics in the past 14 days.
  • Cooperative children.
  • Children are having at least two carious asymptomatic second primary molars.

排除标准

  • Uncooperative children.
  • Immunocompromised children.
  • Children with clinical or radiographic symptoms

研究组 & 干预措施

Allium sativum oil

Experimental

The pulp stumps of the molars are dressed with a cotton pellet that is made damp with Allium Sativum oil for 1 min .

干预措施: Allium Sativum Oil (Drug)

Mineral Trioxide Aggregate

Active Comparator

The material will be prepared according to the manufacturer's instructions , applied to the pulp chamber and a moistened cotton pellet was placed over the MTA paste to allow the material to set.

干预措施: Mineral Tri-Oxide Aggregate (Drug)

结局指标

主要结局

Clinical effectiveness

时间窗: 1 year follow up

clinical effectiveness will be measured by intraoral examination and radiographic assessment

次要结局

  • Cost-effectiveness(1 year follow up)

研究者

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

Lobna Magdy

Researcher

Cairo University

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