Comparative evaluation of the effectiveness of straight elevator v/s twisted elevator in children during extraction of primary grossly decayed teeth and root stumps.
概览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- Kunal Audichya
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Extraction time
概览
简要总结
This randomized controlled trial aims to evaluate and compare the effectiveness of a newly designed twisted elevator versus the conventional straight elevator in pediatric patients requiring extraction of grossly decayed primary teeth and root stumps. Eligible children will be randomly assigned to two groups: Group A (straight elevator) and Group B (twisted elevator). The study will assess extraction time, soft tissue trauma (modified Laskin criteria), intraoperative complications (root or bone fracture), postoperative pain and swelling, and physiological parameters (heart rate and oxygen saturation). It is hypothesized that the twisted elevator may reduce procedure time, tissue trauma, and postoperative discomfort, offering a safe and effective alternative to the conventional straight elevator in pediatric extractions.
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 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Deciduous teeth indicated for extraction due to being grossly decayed or presenting as root stumps.
- •Tooth extractable using elevation/luxation technique without surgical sectioning.
- •ASA I or II physical status.
- •Cooperative behavior allowing extraction under local anesthesia.
- •Parental/guardian consent obtained; child assent where appropriate.
- •Available for postoperative follow-up (24 hours).
排除标准
- •Children with special healthcare needs Frankl behavior rating 1 or 2 Pre-shedding mobility or pathological mobility of teeth Teeth with half root length Teeth with crown fracture extending sub-gingivally.
结局指标
主要结局
Extraction time
时间窗: Extraction time
Soft tissue trauma
时间窗: Extraction time
Intra operative complications
时间窗: Extraction time
次要结局
- Post operative pain & swelling(Heart Rate)
研究者
Kunal Audichya
Pacific dental college and hospital