Comparative evaluation of Pro AF Baby Gold files, Kids E files (Rainbow NiTi), and hand K-files (NiTi Flex) on instrumentation time and postoperative pain following pulpectomy in primary mandibular molars of children aged 4 to 8 years: a randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The study aims to compare instrumentation time and postoperative pain during pulpectomy in primary mandibular molars of children aged 4–8 years using three file systems: Hand K-files (NiTi Flex), Pro AF Baby Gold files, and Kids E-files, with pain assessed up to one week using a four-point Verbal Rating Scale.
研究概览
简要总结
This randomized clinical study will include 75 primary mandibular molars in children aged 4–8 years, divided into three groups based on instrumentation technique: Hand K-files (NiTi Flex), Pro AF Baby Gold files, and Kids E-files (Rainbow NiTi). Pulpectomy will be performed using standard procedures including cleaning, shaping, disinfection, and obturation with a resorbable material. Instrumentation time will be recorded using a digital stopwatch from the start to completion of canal preparation. Postoperative pain will be evaluated at 6, 24, and 72 hours, and at 1 week using a four-point Verbal Rating Scale. Parents or caregivers will be trained to record pain scores
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Primary mandibular molars with irreversible pulpitis or with non-vital pulp
- •Children with no history of analgesic usage within 12 hours prior to the procedure
- •The child should be in good health with no history of major systemic illness or allergies.
- •Patient should be between 4 and 8 years of age.
- •Patients exhibiting Frankl’s behavior rating scale score of 3 (positive (+)) and 4 definitely positive (++).
- •Absence of internal or cervical pathologic root resorption.
- •A minimum of two-thirds of the remaining root length
- •A tooth structure strong enough to hold a rubber dam.
- •Co-operative children and parents willing to follow the instructions and report for follow-up.
排除标准
- •1.Children with systemic illness such as congenital or rheumatic heart disease, hepatitis, and leukemia etc.
- •Clinically, mobile tooth, discolored tooth, and a tooth with sinus opening, fistula, or abscess.
- •Children lacking the cooperative ability.
- •Teeth with internal or external root resorption.
- •Teeth exhibiting pulpal floor perforation.
- •Radiolucent area in the furcation or peri radicular region 7.
结局指标
主要结局
The study aims to compare instrumentation time and postoperative pain during pulpectomy in primary mandibular molars of children aged 4–8 years using three file systems: Hand K-files (NiTi Flex), Pro AF Baby Gold files, and Kids E-files, with pain assessed up to one week using a four-point Verbal Rating Scale.
时间窗: At baseline till seventy two hpurs
次要结局
未报告次要终点
研究者
DHANASHRI SATISH HOLEY
swargiya Dadasaheb Kalmegh Dental College and Hospital