Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Child dental anxiety
研究概览
简要总结
To evaluate the effectiveness of intra-osseous anesthesia using Quicksleepr5 in pain elimination during dental treatment in maxillary and mandibular primary molars, compared to conventional anesthesia.
详细描述
The study will be an eight-armed randomized controlled trial, parallel design. A total of 120 pediatric dental patients aged from 5 to 9 years with good health, will be selected from the Pediatric Dentistry and Dental Public Health Department clinic, Faculty of Dentistry, Alexandria University, Egypt. They will be recruited among those who need local anesthesia to perform either quadrant restorative treatment or extraction of their primary molars. Participants will be allocated into 2 groups according to the local anesthetic technique to be used. Children in the test group will receive intraosseous anesthesia using QuickSleeper5, while inferior alveolar nerve block or infiltration anesthesia will be used for those who are in the control group. All the procedures will be videotaped. Pain response upon needle prick and dental treatment will be assessed subjectively using the visual analogue scale, and objectively using Face, Leg, Activity, cry, Consolability scale. Physiological parameters will also be recorded to determine pain reaction. Efficacy, latency period and duration of anesthesia will be recorded for both injection techniques. Child behaviour toward dental treatment in both injection techniques will be evaluated using Frankl rating scale. Dental anxiety of pediatric patients will be evaluated from the videotapes using VENHAM Clinical Anxiety Scale. Postoperative assessment for the occurrence of any adverse events is planned.
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
- Single (Participant)
盲法说明
participants are blinded to the group assignment, as their visual field is blocked during needle adminstration in both groups, and the Audible sounds of the QuickSleeper5 will be mimicked in the control group.
The operator will not be blinded to the type of the anesthesia administered due to different devices to be used.
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cooperative children during preoperative assessments.
- •Patients selected in the restorative group: presenting with at least one primary molar indicated for restorative treatment or vital pulp therapy, after thorough clinical and radiographic examination.
- •Patients selected in the extraction group: presenting with at least one primary molar indicated for extraction.
排除标准
- •Any physical or mental disability, or psychological problems.
- •Immunocompromised patients.
- •Hypersensitivity to local anesthetic drugs used
- •History of previous dental local anesthesia.
- •Taking analgesics or other medications that would alter the child behavior or awareness of pain 12- hours pre-operative
结局指标
主要结局
Child dental anxiety
时间窗: 1-Preoperative phase (baseline) 2- During local anesthesia administration 3-During dental treatment (restorative or extraction)
It will be assessed using VENHAM Clinical Anxiety Scale
Assessment of Pain Reaction objectively
时间窗: 1- Preoperatively phase (baseline) 2- During LA administration. 3-During dental treatment: Rubber dam placement and tooth preparation Or tooth extraction
Pain response will be assessed using Face, Legs, Activity, Cry Consolability (FLACC) scale
Assessment of Pain Reaction subjectively
时间窗: 1-Post injection phase (1- minute). 2- Post treatment phase (10 minutes)
it will done by the child using Face version of Visual Analogue Scale.
次要结局
- Local anesthesia effect(30 minutes postoperatively)
- Assessment of occurrence of adverse events(follow up 24 hour postoperatively)