跳至主要内容
临床试验/NCT04669392
NCT04669392Unknown早期 1 期

Clinical and Radiographic Evaluation of 70% Ethanol Alcohol Versus Normal Saline as Root Canal Irrigating Solutions in Partial Pulpectomy of Primary Molars With Metapex A Randomized Controlled (Pilot Trial)

Cairo University0 个研究点目标入组 20 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
20
主要终点
Postoperative pain of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.

研究概览

简要总结

The aim of the study is to perform a clinical and radiographic evaluation of 70% Ethanol Alcohol versus Normal Saline as root canal irrigating solutions in partial pulpectomy of primary molars with Metapex.

详细描述

In permanent dentition, Calcium Hydroxide-Iodoform paste (Metapex) has a high potential in forming a calcific barrier in the pulpal tissue. Yet, in primary dentition Metapex forms a chronic inflammatory reaction to the pulpal tissue leading to its internal and root resorption. Although the high success rate of Metapex in partial pulpectomy, the rapid resorption of Metapex has led to the presence of the hollow tube effect due to voids formation in the canals. However, this will cause early root resorption before the time of exfoliation. Due to its rapid resorption, Metapex is usually recommended to be used in the pulpectomy of teeth near exfoliation in order to avoid the early root resorption of primary dentition in order to avoid the premature loss of the endodontically treated vital primary teeth with Metapex.

Saline solution is the basic irrigating solution in root canal treatments, yet it has no antimicrobial activities and only results in cleaning the root canals. Ethanol irrigation is believed to be an alternative promising replacement in tissue fixation from Formocresol due to the concerns from its carcinogenicity and toxicity. Also, Ethanol has an excellent bactericidal, virucidal, and fungicidal, and most importantly it is one of the volatile liquids.

In this study, the effect of Ethanol Alcohol on increasing the success rate of Metapex in vital pulp therapy will 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
Prevention
盲法
None

入排标准

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

入选标准

  • Patients medically within normal.
  • Cooperative patients and cooperative parents.
  • Children aged 4-7 years old.
  • Primary mandibular second molar.
  • Deep carious molars.
  • A history of spontaneous pain.
  • Molars with pulp exposure due to caries.
  • Absences of Internal resorption.
  • Absences of external pathological resorption.
  • where the bleeding could not be stopped following removal of the coronal pulp tissue

排除标准

  • Parents unable to give informed consent.
  • Necrotic pulp.
  • Unrestorable Teeth.

研究组 & 干预措施

70% Ethanol

Experimental

Using 70% Ethanol Alcohol as a root canal irrigating solution before obturating the lower primary second molar with Metapex

干预措施: 70% Ethanol Alcohol (Drug)

结局指标

主要结局

Postoperative pain of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.

时间窗: Patients will be assessed at 12 months follow ups

Assessment through Visual Analog Scale , A score from (0-10) 0 is means no pain and 10 is the maximum level of pain.

次要结局

  • Radiographic evaluation of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.(Patients will be assessed at 12 months follow ups)

研究者

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

Thamar Al-Gannah Samy Rashed

Thamar Al-Gannah Samy Mohamed Rashed

Cairo University

相似试验

The Effect of Using 70% Ethanol Alcohol as a Root... | 临床试验