Efficacy of One-Shape Single-file System in Pulpectomy of Infected Primary Molars: In-vitro and In-vivo Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Pain presence or absence
研究概览
简要总结
The current study evaluates the rotational One Shape single-file system regarding clinical and radiographic outcomes in root canal treatment of infected primary molars.
This randomized clinical trial was carried out on 94 primary molars on children in the age group from 4 to 6 years. The teeth selected for this study were randomly assigned into 2 groups according to the used endodontic preparation system. Group I: 47 primary molars were instrumented with One Shape rotational single-file system. Group II: 47 primary molars were instrumented with stainless steel K-files. All teeth were evaluated clinically and radigraphically for 12 months with periodic recall at 3, 6 and 12 months.
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
- Single (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
- 是
入选标准
- •Children categorized as class I or II according to American Society of Anesthesiologists (ASA).
- •Children aged between 4 and 6 years with at least one necrotic primary second mandibular molar.
- •History of dull toothache over an extended period of time
- •History of spontaneous pain or pain at night
- •Swelling adjacent to tooth with or without a sinus tract
- •Abnormal tooth mobility
- •Presence of necrotic pulp tissue or purulent discharge when the pulp chamber was accessed
- •Interruption of lamina dura or thickening of periodontal ligament space
- •Furcational radiolucency did not surpass half of the distance between the furcation and permanent successor
- •Negative findings of internal root resorption
- •External root resorption confined to the apical third and with at least two-thirds of the root length was intact
排除标准
- •Uncoperative children or parents/legal guardians
- •Sever intellectual, behaviour or emotional problems
- •Non-restorable tooth crowns
- •Root canal obliteration
- •Presence of underlying dentigerous or follicular cysts
结局指标
主要结局
Pain presence or absence
时间窗: one year
score 0 was applied for absence of pain and score 1 was applied for presence of pain
radiographic success or failure
时间窗: one year
it was done using periapical radiograph and score 0 was applied for absence of radiolucency and score 1 was applied for presence of radiolucency
swelling presence or absence
时间窗: one year
score 0 was applied for absence of swelling and score 1 was applied for presence of swelling
次要结局
未报告次要终点
研究者
Osama Seif El-Nasr Hussein Gad El-Hak
assistant lecturer
Minia University