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临床试验/NCT05507359
NCT05507359尚未招募不适用

Effect of Topical Application of Clove Gel Versus Benzocaine Gel on Pain Reduction During Application of Simple Dental Procedures in Children: A Randomized Clinical Trial.

Cairo University0 个研究点目标入组 54 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
54
主要终点
Pain perception during application of rubber dam or matrix band.

研究概览

简要总结

This study is aimed to evaluate the effectiveness of the topical application of clove gel versus topical application of 20% benzocaine gel in pain reduction in children undergoing dental treatment (rubber dam or matrix band application).

详细描述

Pain is an unpleasant sensory and emotional experience that arises from actual or potential tissue damage or described in terms of such damage. In pediatric dentistry, pain sensation is generated by stimuli like the touch of the needle at the time of local anesthetic administration and is not necessarily caused by tissue damage. Poor pain control, anxiety, and fear of the needle might interfere with the acceptance of local anesthesia and lead to inappropriate dental treatment management.

Fear and anxiety are the most common problems in pediatric dentistry. Needle phobias and fear of pain due to needle prick are very common in children, compromising their dental health. Therefore, various methods (pharmacological or non-pharmacological) have been developed to overcome this problem. Topical anesthetics are the gold standard method used to alleviate pain.

In pediatric dentistry, local anesthesia is the most common procedure that can trigger fear and anxiety in children, but it is an essential measure for pain control. Therefore, an alternative for injectable anesthesia is the use of topical anesthetics.

Rubber dam placement is one of the procedures used daily in dental practice. Unfortunately, anxiety is triggered when injectable anesthesia is applied to control the pain during rubber dam placement. Children perceive rubber dam clamp placement as a painful procedure.

Using an effective topical anesthetic can prevent pain, leading to establishing a trust-based and positive relationship between the pediatric dentist and the child, eliminating the child's fears and anxiety, and developing a positive attitude towards future dental treatments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 6-10 years.
  • Cooperative children classified with a rating 3 (positive) or 4 (definitely positive) according to Frankl's behavior rating scale.
  • Children with deep pits and fissures requiring pits and fissures sealant in lower permanent first molars.
  • Children having class II cavities in lower primary second molars indicated for restoration.

排除标准

  • Children with any systemic neurological or psychological disorders.
  • Children with known allergy to topical or local anesthetic agents or clove.
  • Parental refusal of participation.

结局指标

主要结局

Pain perception during application of rubber dam or matrix band.

时间窗: 1 day

It is measured by Wong-Baker pain rating scale Scale from (0-10)

次要结局

  • Child behavior during application of rubber dam or matrix band.(1 day)
  • Heart rate during application of rubber dam or matrix band.(1 day.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Farah Ihab Ahmed Rahmy El Sharkawy

Dr

Cairo University

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