Effectiveness of INJEX Versus Traditional Syringe During Restoration of Primary Teeth: A Randomized Split-mouth 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
- 1
- 主要终点
- The Face, Legs, Activity, Cry, and Consolability (FLACC) Scale
研究概览
简要总结
The main purpose of this study is to make a comparison between pain perception levels and the behavior of patients during the restoration process in children between a needleless local anesthetic system (INJEX) and the conventional syringe technique. The main purpose of this study is to make a comparison between pain perception levels and the behavior of patients during the restoration process in children between a needleless local anesthetic system (INJEX) and the conventional syringe technique.
. The main questions it aims to answer are:
- To evaluate pain perception for restoration of primary molars with a needle free system in a pediatric population.
- To evaluate pain perception for restoration of Primary molars 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 INJEX (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 determined using the following formula, based on a difference in mean Face, Legs, Activity, Cry, and Consolability (FLACC) scores of 1.2 and a pooled standard deviation of 1.89. Sample Size (n) = 2Sp2 (Z 1-α/2+Z1-β) 2 µd2 where, Z (1-α/2) = 1.96 for a 95% confidence interval Z1-β = 0.84 for 80% power Sp2 = pooled standard deviation µd = 1.2 (difference in mean between groups) Substituting these values, the sample size was estimated to be 21. An additional 20% of the estimated sample size was added to account for any potential sampling loss, bringing the final sample size to a total of 25 teeth in each group.
study design: It was a split mouth 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 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 7 - 10 years
- •Existence of deep carious Primary 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
研究组 & 干预措施
INJEX
Needle less device
干预措施: INJEX [ Needle less anesthesia] (Device)
Needle syringe
traditional dental needle
干预措施: INJEX [ Needle less anesthesia] (Device)
结局指标
主要结局
The Face, Legs, Activity, Cry, and Consolability (FLACC) Scale
时间窗: during and immediately after the delivery of anesthesia
FLACC gives an observational pain scale during the delivery of anesthesia
次要结局
- Frankel Behaviour Rating Scale ( FBRS)(before the delivery of anesthesia, during the delivery of anesthesia and after the delivery of anesthesia)
- Pulse rate(Before the delivery of anesthesia, immediately after the delivery of anesthesia, and 1 minute after the delivery of anesthesia)
- Wong Baker Scale(During and immediately after the delivery of anesthesia)
- Time of local anesthesia administration(during the delivery of anesthesia)
研究者
satish vishwanathaiah
Associate Professor
University of Jazan