A New Approach for Controlling Hemostasis During Canal Treatment: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- Change From Baseline in Root Canal Bleeding Score
研究概览
简要总结
Blood contamination, such as apical microleakage, of root canal during preparation can be a major problem in endodontics. The purpose of this investigation was to evaluate the hemostatic properties of sulfonic/sulfuric acid solution used during root canal therapy in teeth with irreversible pulpitis.
详细描述
A new device (HYBENX®) has been developed with the purpose of destroying dental biofilm. The material contains a concentrated aqueous mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%).
The investigators planned a clinical and microbiological study using the decontaminant device in order to destroy the dental biofilm of root canals in cases of irreversible pulpitis. The ability of the decontaminant device to immediately stop bleeding during canal instrumentation was found out accidentally during the procedures of this still unpublished trial.
Due to this fact, the investigators were interested in evaluating the coagulation property of the material. Therefore, the aim of this prospective study is to describe a new approach to obtain hemostasis during root canal therapy using a sulfonic/sulfuric acid solution.
A total of 15 teeth with irreversible and acute pulpitis were included in the study. After manual and mechanical instrumentation of the root canal, a sterile paper point was introduced in the canal, and a first score was given based on the blood quantity.
The solution was used to irrigate the bleeding root canal; then a second sterile paper point was introduced, and the same score was assessed. The null hypothesis was that there is no difference in root canal bleeding before and after the use of the solution (⎧=0)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •tooth affected by irreversible pulpitis, single-rooted teeth associated with healthy periodontium, physiologic sulcus depth (<3 mm), and absence of bleeding on probing of the involved teeth.
排除标准
- •patients with systemic diseases using anticoagulants, antibiotics, or anti-inflammatory therapies in the last 30 days, patients with allergy to sulfur in any form, and pregnancy.
研究组 & 干预措施
HYBENX®
1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec
干预措施: HYBENX® (Device)
结局指标
主要结局
Change From Baseline in Root Canal Bleeding Score
时间窗: 20 sec - before and after use
After the root canal, shaping was performed, and a first sterile paper point was introduced in the root canal, up to the working length, to detect blood presence. The root canal bleeding score (RCBS) was given as follows: * 0: no blood detected * 1: blood detected in the apical third of the root canal * 2: blood detected both in the apical and the middle thirds of the root canal * 3: blood detected in the whole root canal. After the use of the material a second sterile paper point was introduced in the root canal, up to the working length, to detect the presence of blood and an RCBS was assessed according the previous criteria
次要结局
未报告次要终点
研究者
Dr Riccardo Pace
Principal Investigator
Azienda Ospedaliero-Universitaria Careggi