Comparative evaluation of Low Level Laser Therapy (LLLT)and topical LA spray in reducing needle prick pain during inferior alveolar nerve block in pediatric patients- a randomized control trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Low Level Laser Therapy reduces needle prick pain during inferior alveolar nerve block in children
研究概览
简要总结
This is as split mouth design study involving 30 children aged 7to 11 years requiring bilateral extraction of mandibular teeth. After obtaining informed consent eligible participants will be randomly allocated using the SNOSE technique. One side will receive Low Level Laser Therapy with 810 nm radiation at the local anesthesia site and the other side will serve as control receiving inactive laser and topical anesthetic spray. A placebo cotton pellet dipped in cold water will mimic the spray effect on the experimental side. Standardized extraction procedures and postoperative analgesics will be given. Pain perception will be evaluated immediately after LA administration using a 10 cm Visual Analog Scale, ranging from 0 with no pain to 10 with severe pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 11.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients whose parents assent to participate in the study voluntarily Patients of age group between 7 to 11 years Patients indicated for bilateral extraction of lower teeth and requiring same LA technique Patients with Frankles positive and definitely positive behaviour rating Patients undergoing the treatment of extraction for the first time Children who are not on any medication Patients who are not suffering from any systemic illness.
排除标准
- •Patients who are allergic to LA Patients who are showcasing local inflammation or tenderness at the site of LA Patients who are suffering from systemic illness and are on any drugs Patients who are not willing to participate in the study Patients with Frankle negative and definitely negative behaviour rating Patients who have already undergone the treatment of extraction before Patients who are unfit to meet any of the above mentioned criteria.
结局指标
主要结局
Low Level Laser Therapy reduces needle prick pain during inferior alveolar nerve block in children
时间窗: immediately after giving LA
次要结局
- positive behaviour and faster and successful dental treatment for child(baseline 2 visits)
研究者
Dr Sadanand Kulkarni
Martha Mandals N G H Institute of Dental Sciences and Research Centre