Comparison of SleeperOne® 5-Assisted Intraosseous and Conventional Local Anesthesia for Pain and Anxiety Control in Children With Molar-Incisor Hypomineralization: A Randomized Split-Mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Pain Perception During Anesthetic Administration
研究概览
简要总结
This randomized split-mouth clinical trial evaluates whether computer-controlled intraosseous anesthesia delivered with the SleeperOne® 5 system reduces pain perception and dental anxiety compared with conventional local anesthesia during restorative treatment of children with molar-incisor hypomineralization (MIH). Thirty-five children received both anesthesia techniques in separate treatment sessions. Pain perception, behavioral responses, dental anxiety, pulse rate, and oxygen saturation were assessed at predefined time points.
详细描述
Molar-incisor hypomineralization (MIH) is a developmental enamel defect that frequently presents with hypersensitivity, post-eruptive enamel breakdown, and an increased risk of restorative treatment failure. Achieving effective local anesthesia in children with MIH can be challenging because hypersensitive teeth often exhibit increased pain during anesthetic administration and restorative procedures. These factors may compromise patient cooperation and the quality of dental treatment.
Computer-controlled local anesthetic delivery systems have been developed to improve injection comfort by controlling the rate and pressure of anesthetic administration. The SleeperOne® 5 system allows computer-controlled intraosseous anesthesia and may provide more effective pain control than conventional local anesthesia during restorative treatment of MIH-affected teeth.
The purpose of this study was to compare SleeperOne® 5-assisted intraosseous anesthesia with conventional local anesthesia in children undergoing restorative treatment of permanent first molars affected by MIH.
The study was conducted as a randomized split-mouth clinical trial in which each participant received both anesthetic techniques during separate treatment sessions. The order of the interventions was determined using computer-generated randomization, allowing each participant to serve as his or her own control. All clinical procedures were performed under standardized conditions by the same operator.
The study was designed to evaluate whether computer-controlled intraosseous anesthesia could improve pain control and patient comfort during restorative treatment of children with MIH compared with conventional local anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the obvious differences between the computer-controlled intraosseous anesthesia device (SleeperOne® 5) and the conventional dental syringe, masking of the investigator and participants was not feasible. The same investigator performed both the interventions and the outcome assessments throughout the study.
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 8 to 14 years.
- •Bilateral symmetrical MIH-affected permanent first molars requiring restorative treatment.
- •MIH diagnosed according to EAPD criteria.
- •Positive or definitely positive Frankl Behavior Rating Scale.
- •Parent or guardian provided written informed consent.
排除标准
- •Acute pulpal or periapical pathology.
- •Developmental dental anomalies other than MIH.
- •Allergy to local anesthetic agents.
- •Medical contraindication to local anesthesia.
- •Analgesic or anti-inflammatory drug use within 24 hours before treatment.
- •Cognitive or communication disorders affecting study assessments.
- •Uncooperative behavior.
研究组 & 干预措施
SleeperOne® 5-Assisted Intraosseous Anesthesia
Computer-controlled intraosseous anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars.
干预措施: SleeperOne® 5 Computer-Controlled Intraosseous Anesthesia (Device)
Conventional Local Anesthesia
Conventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars.
干预措施: Conventional Local Anesthesia (Procedure)
结局指标
主要结局
Pain Perception During Anesthetic Administration
时间窗: Immediately after completion of local anesthesia administration (T1)
Pain intensity during local anesthetic administration assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
次要结局
- Behavioral Pain Response(Immediately after completion of local anesthesia administration and immediately after completion of the restorative treatment procedure.)
- Dental Anxiety(Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.)
- Pulse Rate and Peripheral Oxygen Saturation (SpO₂)(Before local anesthesia administration (T0), immediately after local anesthesia administration (T1), and immediately after restorative treatment (T2).)
- Pulse Rate(Before local anesthesia administration (T0), immediately after local anesthesia administration (T1), and immediately after restorative treatment (T2).)
- Peripheral Oxygen Saturation (SpO₂)(Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.)
研究者
Burcu Nihan Yüksel
Associate Professor
Ankara University