Effectiveness of Intraosseus Injection Using Extra-short Needle Combined With Infiltration in Pediatric Patients With Molar Incisor Hypomineralization (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in objective pain reaction
研究概览
简要总结
Background: Effective pain control is crucial in managing pediatric dental patients. Molar-incisor hypomineralization (MIH), marked by enamel defects and dentin hypersensitivity, often hinders effective local anesthesia. Traditional injection methods may fall short, causing discomfort and complicating treatment. Combining infiltration with intraosseous injection using an extra-short 31-G needle may offer a more effective alternative.
Purpose: To compare the effectiveness of combined infiltration and intraosseous injection with an extra-short 31-G needle versus conventional techniques in eliminating pain during
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)
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy children, American Society of Anesthesiologists class I, II
- •Cooperative children during preoperative assessments according to the Frankl'
- •Behavioral Rating Scale (scores 3 or 4)
- •Patient presenting with at least one hypersensitive SCASS 2,3 [22] (Appendix III) deeply carious, MIH-affected FPM, with caries extending to the inner third of the dentin and close to the pulp, as shown in the periapical radiograph, consistent with TNI 4c classification for MIH
- •Written consent of the legal guardian.
排除标准
- •Any physical or mental disability or psychological problems.
- •Immunocompromised patients.
- •Hypersensitivity to local anesthetic drugs used.
- •Taking analgesics or other medications that alter the child's behavior or awareness of pain 12- hours pre-operatively
- •Patients requiring emergency treatment.
- •FPM with preoperative signs and symptoms of clinical failure
研究组 & 干预措施
Intraosseous
干预措施: intraosseus anesthesia (Other)
Conventional nerve block
干预措施: Conventional nerve block (Other)
结局指标
主要结局
Change in objective pain reaction
时间窗: throughout the procedure
Pain response will be assessed using Face, Legs, Activity, Cry Consolability (FLACC) scale The scale has five criteria, each assigned a score of 0, 1 or 2 (zero means no pain and 2 means severe pain). The total score scale is scored in a range of 0-10 with 0 representing no pain
Change in subjective pain scores
时间窗: throughout the procedure
It will be done by the child using Wong-Baker Faces Pain Rating Scale that ranged from 0 to 5. zero means no pain and 5 means pain is severe
次要结局
- change in child anxiety(throughout the procedure)
- Local anesthesia efficacy(throughout the procedure)