Evaluation of the Effectiveness of the Comfort-In Needle-Free Injector System During Palatal Infiltrative Anesthesia in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Pain Perception of Wong-Baker Scale
研究概览
简要总结
The goal of this randomized clinical trial is to compare two different injection methods in children. The main question it aims to answer is:
Is the needle-free injection method more painless than the traditional dental method?
Two different methods will be used for children to perform anesthesia for extraction permanent molars.
详细描述
Study Groups and Study Design: 56 volunteer children between the ages of 6-15 who applied to Faculty of Dentistry Department of Pedodontics clinic with their parents were included in our study. Volunteer children with an indication for maxillary permanent first molar tooth extraction were randomly divided into two groups and included in the study. For randomization, methods were written on two different envelopes and the child was allowed to choose the envelope. The child was assigned to the selected method. Group Control: Application of Traditional Dental Injection Method Palatal injection; It was applied 5-10 mm below the palatal gingival margin*, on the attached gum, and with a 45-degree needle angle. After needle entry, 0.2-0.3 mL of anesthetic solution was stored when bone contact was removed (3-5 mm). 1 mL Articaine Hydrochloride (Ultracaine D-S forte, Hoechst, Canada) containing 1/100,000 epinephrine and a 27 G dental needle were used as local anesthetic agents for injections. 25 patients were included in this group and the procedure was performed. After waiting for 5 minutes, the anesthetized area was probed with the help of a probe (probing gingiva) to check whether the anesthesia had taken effect. Afterwards, buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed. Group Experimental: Application of Comfort-in Jet Injection Method Comfort-in jet injection method was used for palatal anesthesia of the permanent 1st molar. Using a silicone flat cap, it was placed 5 mm below the palatal gingival margin, close to the free gingiva, and with a steep angle. 0.3 ml of anesthetic solution was administered by pressing the jet injection system button. 1 mL Articaine Hydrochloride (Ultracaine D-S forte, Hoechst, Canada) containing 1/100,000 epinephrine was used as a local anesthetic agent in the injections. 31 patients were included in this group and the procedure was performed. After waiting for 2 minutes, the anesthetized area was probed with the help of a probe (probing gingiva) to check whether the anesthesia had taken effect. Afterwards, buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed.
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
- None
盲法说明
When giving data to the statistician, he will not be told which group the data is in. The data will be changed to a and b to try to prevent bias.
入排标准
- 年龄范围
- 6 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child patient between the ages of 6-16, Requiring extraction of maxillary permanent molars and premolars with bilateral palatal infiltration anesthesia, Showing "positive" and "definitely positive" behavior during examination according to the Frankl scale, Family volunteers, No medical or developmental disease
排除标准
- •If there are medical or developmental disorders, If there is a chronic disease, If there is an allergy to anesthetic solutions, If there is any pathology in the anesthesia area, If the Frankl scale is "negative" and "definitely negative", If the mouth opening is not sufficient, If there is no need for symmetrical treatment in the teeth
结局指标
主要结局
Pain Perception of Wong-Baker Scale
时间窗: After the anesthesia method is applied, the patient is asked to score the pain they feel
The investigators expect the comfort-in jet injection method to produce a lower score on the Wong-Baker pain scale than the traditional anesthesia method.The Wong-Baker pain scale is scored between 0-10. 0 means the patient has no pain and 10 means they feel very severe pain.
Pain Perception of The Face, Legs, Activity, Cry, and Consolability (FLACC) scale
时间窗: The video taken to look at the patients body reactions during the application of the anesthesia method is evaluated and scored after the procedure is completed.
The investigators expect the comfort-in jet injection method to produce a lower score on the FLACC scale applied to pain acceptance in pediatric patients compared to the traditional anesthesia method. The FLACC pain scale is scored between 0-10. 0 means that the patients pain acceptance is good and 10 means that the pain acceptance is low.
次要结局
未报告次要终点
研究者
Halenur Altan
Associated professor
Necmettin Erbakan University
