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临床试验/NCT05959642
NCT05959642尚未招募不适用

Comparing Controlled Flow Delivery Dentapen® Technique to Traditional Syringes on Pain Perception During the Administration of Anesthesia Among A Group of Pediatric Dental Patients: A Split-Mouth Randomized Clinical Trial

Cairo University0 个研究点目标入组 20 人开始时间: 2024年1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
20
主要终点
Pain perception during injection of local anesthesia

研究概览

简要总结

This study compares the effect of the controlled flow delivery Dentapen® technique to traditional syringes on pain perception during dental procedures among a group of pediatric dental patients

详细描述

Local anesthetic injections are usually the main reason for fear and anxiety during dental treatment. Pain management is a critical aspect of pediatric dental care. Fear associated with seeing and experiencing needle penetration, sensation of swelling soft tissues and prolonged numbness as well as allergic reactions to the anesthetic fluid, are the most common factors causing patients and dental clinicians to experience anxiety regarding the use of infiltration local anesthesia. Exploring new alternative and a traumatic method will help improving the quality of care in pediatric dentistry.

Consequently, there is a constant search for new techniques looking to avoid the invasive and often painful nature of the anaesthetic injection required for dental treatments, making it a more pleasant and less distressing experience for patients.

Even though there are no techniques available that can totally replace conventional local anaesthesia, some alternatives have been developed that are effective in a limited range of procedures. In 1997, a new method for the administration of anaesthetics was launched: the computer- controlled local anaesthesia delivery system (CCLADS). After

2006, the single tooth anaesthesia system (STA) (Milestone Scientific, Inc. Livingston, NJ, USA) was also introduced.

Currently, one of the most discouraging aspects for many patients undergoing dental procedures is the administration of anaesthesia. Consequently, there is a constant search for new techniques to avoid the invasive and painful nature of the injection. A new, cableless, motorised syringe system (Dentapen®) has recently been developed, standing out for its convenience and ease of use. The slow injection of anaesthetics at low pressure appears to reduce pain and discomfort during dental anaesthesia, and that currently does not require specific training. It has several injection settings, allowing it to be held like a syringe or pen, and is compatible with all anaesthetic needles and cartridges from all brands with an accurate control of flow and pressure of the injection can therefore mitigate the pain experienced by these patients.

研究设计

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

入排标准

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

入选标准

  • Children aged between 6 and 8 years
  • Healthy children with no systemic problems.
  • Cooperative Children
  • First dental visit
  • Children willing to provide assent and parent willing to provide informed consent
  • Bilaterally decayed primary maxillary first molars with normal radiographic findings and need restorative treatment

排除标准

  • Children with previously restored teeth
  • Children requiring emergency dental treatment (cellulitis, abscess)
  • Children's teeth with signs or symptoms of Pulpitis
  • Children whose parents refuse to sign the informed consent.

结局指标

主要结局

Pain perception during injection of local anesthesia

时间窗: in the same visit after finishing the procedure, 0 scale - no pain , 10 scale -worest

Wong-Baker faces pain rating scale; Scores (0-10)

次要结局

  • Heart rate during injection of local anesthesia(in the same visit after finishing the procedure)

研究者

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

reham salman alshakhs

Master Degree Student

Cairo University

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