Comparison of Needle-Free Injection and Conventional Syringe in Tooth Extractions in Children: Effects on Pain, Anxiety, and Vital Signs
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Anxiety level measured by Face Image Scale
研究概览
简要总结
The goal of this clinical trial is to learn whether a needle-free injection system can make tooth extraction less stressful for children than a conventional dental syringe. The study will include healthy children 6 to 12 years old who need a primary tooth extraction with buccal and lingual local anesthesia. The main questions are whether the needle-free method can lower anxiety, lower pain, and reduce changes in vital signs compared with the conventional syringe.
Researchers will randomly assign participants to 1 of 2 groups. One group will receive local anesthesia with a needle-free jet injection system. The other group will receive local anesthesia with a conventional syringe and a 27-gauge dental needle. In both groups, a topical lidocaine spray will be used before the injection, and the same anesthetic solution will be given. All tooth extractions will be performed by the same clinician using standard clinical procedures.
Participants' anxiety, pain, and vital signs will be checked before the procedure, after anesthesia, and after tooth extraction. Anxiety will be measured with the Face Image Scale (FIS). Pain will be measured with the Face, Legs, Activity, Cry, Consolability (FLACC) scale and the Wong-Baker Faces Pain Rating Scale (WBS). Vital signs will include systolic and diastolic blood pressure, heart rate, and oxygen saturation. No blood, saliva, or tissue samples will be collected, and no audio or video recording will be made.
详细描述
Purpose: The aim of this study is to compare the clinical efficacy of the needle-free jet injection system and the conventional syringe used during tooth extractions in pediatric patients aged 6-12 years. In the study, it is aimed to make a scientific contribution to the development of more comfortable and acceptable anesthesia options in pediatric dentistry by evaluating the effects of both methods on children's pain perception, anxiety level, and physiological responses.
Scope: The study includes healthy pediatric patients aged 6-12 years who have an indication for extraction. Patients will be divided into two groups by randomization; in one group, a needle-free jet injection system will be used, and in the other group, buccal and lingual infiltrative anesthesia will be administered with a conventional syringe.
For the evaluation of pain and anxiety, the Face Image Scale (FIS), Wong-Baker Scale (WBS), and FLACC scale will be used, while systolic and diastolic blood pressure, pulse rate, and oxygen saturation will be used for monitoring physiological responses. Measurements will be performed at predetermined times before the intervention, after anesthesia, and after tooth extraction.
In light of the data to be obtained, the study aims to demonstrate the applicability, reliability, and contribution of the needle-free anesthesia method to patient compliance in children.
General Information Anxiety and pain experienced during dental treatment are among the most important factors that negatively affect compliance with treatment, especially in pediatric patients. Although local anesthesia is the most frequently used method for pain control in pediatric dentistry, needle application is one of the most important causes of anxiety and fear in children. In particular, injections administered to palatal and lingual regions with a dense nerve network are considered among the most painful procedures by children.
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
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between 6-12 years of age
- •Having a primary tooth to be extracted with buccal and lingual anesthesia
- •Being in category 2, 3, or 4 according to the Frankl Behavior Scale
- •Being systemically healthy
- •No known history of allergy to local anesthetics
- •No antibiotic use in the last month and no analgesic use in the last 12 hours
- •Not having acute dental pain
- •Having sufficient cognitive ability to understand the anxiety assessment scales
- •Voluntary participation with written parental consent
排除标准
- •Being under 6 years of age or over 12 years of age
- •Displaying category 1 behavior according to the Frankl scale
- •Presence of severe acute dental infection or a condition requiring emergency intervention
- •Presence of a requirement for surgical extraction in the tooth indicated for extraction
- •Incomplete root development of the underlying permanent tooth
- •History of systemic disease (for example heart disease, uncontrolled asthma, epilepsy, diabetes)
- •Inability to use pain/anxiety scales due to neurological or developmental disorder
- •History of allergic reaction to local anesthetics or other drugs used
- •Presence of hypersensitivity to odors or inhalation intolerance
- •Refusal of participation by the child or parent
研究组 & 干预措施
Needle-Free Jet Injection
articipants will receive local anesthesia with a needle-free jet injection system for tooth extraction.
干预措施: Needle-Free Jet Injection System (Device)
Conventional Syringe
Participants will receive local anesthesia with a conventional syringe and a 27-gauge dental needle for tooth extraction.
干预措施: Conventional Syringe Injection (Procedure)
结局指标
主要结局
Anxiety level measured by Face Image Scale
时间窗: Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.
Anxiety will be assessed using the Face Image Scale (FIS), a 5-face visual anxiety scale with scores ranging from 1 to 5. Higher scores indicate greater anxiety (worse outcome).
Pain level measured by Wong-Baker Faces Pain Rating Scale (WBS)
时间窗: Immediately after completion of local anesthesia administration and immediately after tooth extraction during the same visit.
Self-reported pain will be assessed using the Wong-Baker Faces Pain Rating Scale, a 6-face scale with scores ranging from 0 to 10. Higher scores indicate greater pain (worse outcome).
Pain level measured by Face, Legs, Activity, Cry, Consolability (FLACC) scale
时间窗: Immediately after completion of local anesthesia administration and immediately after tooth extraction during the same visit.
Observed pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, with total scores ranging from 0 to 10. Higher scores indicate greater pain or distress (worse outcome).
次要结局
- Diastolic blood pressure(Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.)
- Systolic blood pressure(Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.)
- Heart rate(Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.)
- Oxygen saturation(Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.)
研究者
Semih Ercan Akgun
Lecturer
Ondokuz Mayıs University