Comparative evaluation of hand files and two rotary systems for pulpectomy in children aged 4-9 years: A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Obturation Quality
研究概览
简要总结
The Principal Investigator will perform the procedure under Standard Operating Protocols. Patients allocated to Group I will be treated using Hand files, Group II will be treated using Kedo Nano Plus Rotary Files and In Group III Neoendo Pedoflex Files will be used. The teeth selected for the study will be isolated using Rubber dam and the pulpectomy procedure will be carried out in primary molars. The post-operative evaluation of the obturation quality will be done using Modified Coll and Sedrian criteria Instrumentation Time will be recorded using stopwatch. Evaluation of postoperative pain will be done using the Wong-Baker Faces Pain Rating Scale. Parents/guardians will be instructed to record pain on the scale at 24, 48, and 72 h, which will be given to them along with the patient’s information sheet. All the pain scores will be recorded telephonically and the collection of the Patient information sheet will be done on the subsequent follow up visit. Postoperative instructions will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Children in the age group of 4-9 years • Children with Frankl’s behavior rating scale of definitely positive (++) and positive (+) • Tooth with the history of spontaneous pain • Tooth with irreversible pulpitis • Primary molars with at least remaining two third of the root length.
排除标准
- •Children with systemic diseases and special health care needs
- •Non-vital teeth having signs of abscess, sinus and fistula
- •Primary molars with pathologic mobility and evidence of root fracture, trauma
- •Primary molars having furcation radiolucency
- •Primary molars with calcified root canals
- •Primary molars with more than two third root resorption, internal resorption and developmental anomalies
- •Patients who are not willing to undergo treatment.
结局指标
主要结局
Obturation Quality
时间窗: Obturation Quality
次要结局
- Postoperative Pain
- Instrumentation Time
研究者
Dr Snehal Kumthekar
KAHERs KLE V.K. Institute of Dental Sciences, Belagavi