Effectiveness of a Needle-free Local Anesthetic Technique Compared to the Traditional Syringe Technique for the Restoration of Primary Molars and Young Permanent Molars: A Single-blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of needle free system and dental needle system [Traditional syringe system] for restoration of Primary and young permanent teeth. The main questions it aims to answer are:
- To evaluate pain perception for restoration of primary and young permanent tooth with a needle free system in a pediatric population.
- To evaluate pain perception for restoration of primary and young permanent tooth with needle syringe [Traditional syringe system] method in a pediatric population
- Time required to deliver anesthesia using needle free system vs Needle syringe [ traditional syringe system]
Participants who enrolled in the study will be anesthetized according to the respective groups i,e needle free system and traditional dental needle system and restoration will be done.
详细描述
Before the start of the study a written informed consent and ascent was obtained from each parent of the children included in the study stating they accepted the treatment. Ethical clearance will be obtained before the start of the study. Patients reporting to the dental clinics, college of dentistry will be included in the study.
Sample size estimation:
the sample size was estimated to be twenty-one (21). Twenty percent of the estimated sample size was added to compensate for sampling loss if any, thus the final sample size accounted to a total of twenty-five (25) participants in each group.
study design: It was a single blinded randomized controlled trial
Randomization:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 7 - 14 years
- •Existence of deep carious Primary and Permanent molar, indicated for Indirect pup capping.
- •Complete physical and mental health without any confounding medical history
- •Parents who gave written informed consent
排除标准
- •Children below 7 years of age
- •Children complaining of irreversible pulpitis.
- •Children with Negative behaviour according to the wright's modification of Frankl
- •Behaviour Rating scale (FBRS) during initial examination
- •Children with medical or mentally compromised
结局指标
主要结局
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children
时间窗: During and immediately after the delivery of anesthesia
Wong Baker Scale. Used to self-assess and effectively communicate the severity of pain they may be experiencing
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/ syringe needle in children
时间窗: during and immediately after the delivery of anesthesia
FLACC assessment. FLACC gives an observational pain scale during the delivery of anesthesia
次要结局
- Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children(during the delivery of anesthesia)
研究者
satish vishwanathaiah
Associate professor
University of Jazan