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临床试验/CTRI/2025/06/089124
CTRI/2025/06/089124尚未招募2 期

Assessment of efficacy of prewarmed anesthetic solution and buffered anesthetic solution on precooled injection site in paediatric patients for inferior alveolar nerve block- A Randomized split mouth control trial

Dr sowmiya M1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年1月11日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Injecting pre warmed or buffered local anesthetic solution on precooled injection site (less pain perception) can be a better alternative to conventional local anesthetic technique

研究概览

简要总结

Group 1: prewarmed vs conventional local anesthetic solution; Group 2: buffered vs conventional local anesthetic solution; Group 3: prewarmed vs buffered local anesthetic solution; A split mouth randomized control trial will be conducted on 120 children, 5 to 12 years of age requiring pulp therapy bilaterally on primary mandibular molars. The participants are selected from the patient reporting to the department of paediatric and preventive dentistry. The study will be carried out with the help of two  investigators. The first investigator will select the patient and the selected patient will be randomly divided into 3 equal groups (Group 1, 2, 3) having 40 patients in each group. Randomization will be done using lottery method and the child will be recruited for the study. Once the group was selected, the site for precooling the injection site and for the administration of local anesthetic solution will be selected randomly by coin toss method. This would determine which technique should be administered on first appointment. The alternate technique will be administered during second appointment. The second investigator will assess the anesthetic efficacy, pain during injection and pulp therapy

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 and Outcome Assessor Blinded

入排标准

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

入选标准

  • Patient diagnosed with symptomatic irreversible pulpitis in primary mandibular first or second molar bilaterally.
  • Patient between the age group of 5-12 years.
  • Frankel behaviour rating scale : positive and definitely positive.
  • No previous history of receiving dental injections.

排除标准

  • Children with history of medically compromising conditions.
  • Medical history suggestive of known or suspected allergies to lignocaine.
  • Patient who had taken analgesics within 24hour preceding the commencement of the endodontic procedure.
  • Any abscess or swelling involving the tooth.

结局指标

主要结局

Injecting pre warmed or buffered local anesthetic solution on precooled injection site (less pain perception) can be a better alternative to conventional local anesthetic technique

时间窗: At the time of injection

次要结局

  • early onset of pre warmed or buffered local anesthetic solution on precooled injection site & it can be a better alternative to conventional local anesthetic technique.(after 2 to 3 minutes of injection)

研究者

发起方
Dr sowmiya M
申办方类型
Other [self]

研究点 (1)

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