跳至主要内容
临床试验/NCT06393777
NCT06393777Unknown不适用

Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain Associated With Dental Injections (Infiltration) Prior to Extraction in 6-8 Years Old Children In Comparison to Topical Anesthesia. (RCT)

Cairo University0 个研究点目标入组 14 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
14
主要终点
Pain perception during Dental injection Dental injection Pain perception during Dental injection

研究概览

简要总结

This study aims to assess Effectiveness of Pre-administered Natural Sweet-tasting Solution (honey) for Decreasing Pain Associated with Dental Injections (infiltration) prior to dental extraction in 6-8 years old healthy Children (first dental visit) In comparison to topical anesthesia.

详细描述

The administration of local anesthetics is one of the most dreaded or anxiety-inducing triggers in a dental setup. Patients, particularly children, may be fearful of dental injections, which may prevent them from seeking dental treatment. Even though profound local anesthesia aids in the treatment of pediatric patients in terms of reducing their anxiety and pain during restorative and surgical procedures, the fear of needles has been cited as a barrier to develop proper dental care. Numerous techniques have been researched in an attempt to minimize the pain and distress associated with these dental injections, varying from localized methods to distraction techniques. The localized methods include application of topical agents, altering the rate of injection, increasing the pH of local anesthetics by buffering and pretreatment with lasers. Instruments such as CCLA System (computer-controlled local anesthetic delivery system) and dental vibe are also available to make dental injections more comfortable. Studies have found that sweet flavored solutions, mainly 30% sucrose, given orally prior to cutaneous procedures can reduce discomfort in neonates undergoing heel sticks and venipuncture. Effectiveness of sucrose in the treatment of, procedural pain in newborns and babies has been verified in a Cochrane reviews.

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
Double (Participant, Outcomes Assessor)

盲法说明

This research will be a double blinded study, where the patient (participant) and the statistician will be blind to the treatment groups.

入排标准

年龄范围
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children within the age group 6 to 8 years were selected since the cognitive skills necessary for the use of visual analogue scale for pain assessment have not developed in children younger than 6 years of age.
  • •Mobile deciduous second molars bilaterally that could be treated under infiltration anesthesia.

排除标准

  • •History of allergy to any components of local anesthetic agents used during the study.
  • •Dental or dentoalveolar abscess.
  • •Presence of any underlying systemic disease.
  • •Immunocompromised patients.

研究组 & 干预措施

topical anesthesia

Other

benzocaine 20% gel was applied to the test sites on side of the jaw with a cotton tip applicator which was completely soaked for a period of 5 minutes.

干预措施: honey (Dietary Supplement)

Effect of Pre-administered honey for Decreasing Pain of Dental Injections

Experimental

The participants were asked to drink 5 mL of honey solution before injecting on the experimental side, the patient was asked to hold the solution in the mouth for a minute and then to spit it out .

干预措施: honey (Dietary Supplement)

结局指标

主要结局

Pain perception during Dental injection Dental injection Pain perception during Dental injection

时间窗: 1 year

Wong-Baker ratting scale 0 happy ,2 hurts a little bit,4 "hurts a little more"6 hurts even more,8 hurts a whole lot"10hurts worst" Rating scale Wong-Baker Rating scale

次要结局

  • Child behavior during dental injection(1 year)

研究者

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

Alaa Ahmed Lotfy Mohamed Saleh

principle investigator

Cairo University

相似试验