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临床试验/CTRI/2023/04/051479
CTRI/2023/04/051479尚未招募不适用

Effect of Diode Laser Photobiostimulation on Reversal of Oral Soft Tissue Local Anesthesia in Pediatric Patients – A Split-mouth Randomized Clinical Trial.

Vishnu Dental College1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
duration of LA reversal

研究概览

简要总结

Local anesthesia (LA) is a major mode of pain control in pediatric dental practice, but it comes with the drawback of prolonged duration of action even after the completion of dental treatment procedure. This unwanted prolonged action of LA may cause lip and cheek bites in children. There are very few methods to reverse the LA effect, this present study is to explore the use of Laser photobiostimulation for this purpose.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
8.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 1.Children with Frankel’s positive and definitely positive behavior are included.
  • 2.Children aged 8 to 12 years with the ability to understand and respond to the sensation of soft tissue.
  • Patients who require infiltration anesthesia bilaterally in two different sessions (1ml to 1.5ml /session).
  • Non-allergic to local anesthesia and its components.
  • Patients who are not under any analgesic drugs at least 24 h before treatment.

排除标准

  • Presence of any systemic conditions preventing dental treatment under local anesthesia.
  • Failure of the child to appreciate the response to soft tissue anesthesia, during the training.
  • Children receiving more than one shot of local anesthetic drug.
  • Duration of treatment exceeding 30 minutes from time LA administration.

结局指标

主要结局

duration of LA reversal

时间窗: 1 week intervel

次要结局

  • heart rate(incidence of any adverse effects)

研究者

申办方类型
Other [private dental college]

研究点 (1)

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