跳至主要内容
临床试验/NCT06827223
NCT06827223尚未招募不适用

Comparative Evaluation of the Effect of Computer-controlled Starpen Automatic Injection Device Versus Traditional Syringe on Pain Perception During Nerve Block Anesthesia and Extraction of Mandibular Primary Molars: a Randomized Controlled Trial

Cairo University0 个研究点目标入组 66 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
主要终点
Subjective Pain perception during injection of local anesthesia

研究概览

简要总结

The present study aims to evaluate the effect of computer-controlled Starpen automatic injection device versus the traditional syringe on pain perception during Injection of nerve block anesthesia and extraction of mandibular primary molars.

详细描述

Pain is "An unpleasant sensory and emotional experience connected to actual or potential tissue damage or described in terms of such damage". According to the American Academy of Pediatric Dentistry, a patient may experience serious physical and psychological complications from improper pain management.

Anxiety, a fear of dental procedures, is often linked to unpleasant stimuli such as needle phobia, high vibration, noises, pain, and the smell of materials or medications. Patients who experience anxiety often exhibit complex behavior before or during dental procedures, causing additional discomfort.

In most dental procedures, Local anesthetic (LA) is crucial to alleviate pain during dental procedures enabling the dentist to complete the process. Even though LA is used to reduce pain during the procedure, but traditional methods itself can cause pain, making pediatric patients anxious and uncooperative in dental offices.

Effective pain management is crucial for children receiving dental injections to promote comfort, cooperation, and compliance. These techniques include topical analgesics, distraction, injection rates, buffering and warming the local anesthesia, speed reduction, fine needles, and precooling. Yet, no conclusive painless injection technique has been developed yet.

Finally, The Wand system, developed in 1997 by Milestone Scientific Inc., it was the first Computer-Controlled Local Anesthesia Delivery (CCLAD)discovered. Other devices like Morpheus, Calaject, Quicksleeper, and Smartject have entered the market, these systems varying in injection speed, design, weight, and shape, so, dentists can select the one that best meets their requirements.

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
None

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 aged 6-8 years
  • •Cooperative children (Rating 3 or 4 based on the Frankl behavior scale)
  • •Medically fit children (ASA I).
  • •Children are mentally capable of communication.
  • •First dental visit.
  • •Patient requiring extraction of lower primary molars due to root caries, crown fractures, periapical disease, and failed pulpotomies.

排除标准

  • •Children with a behavioral management problem.
  • •Parental refusal of participation.
  • •Children with a previous history of local anesthesia injection.
  • •Medically unfit children (other than ASA I).
  • •Uncooperative children (other than Frankl 3,4).
  • •Children under medications (antibiotics and analgesics) for the previous 48 hours that could alter the pain perception.
  • •Teeth that showed any signs of mobility, ankylosis, or root resorption affecting more than one-third of the root

研究组 & 干预措施

control group

Active Comparator

nerve block anesthesia and extraction of mandibular primary molars using a Traditional Syringe

干预措施: Traditional Syringe (Device)

intervention group

Experimental

nerve block anesthesia and extraction of mandibular primary molars using Computer-controlled Starpen Automatic Injection Device

干预措施: computer-controlled Starpen Automatic Injection Device (Device)

结局指标

主要结局

Subjective Pain perception during injection of local anesthesia

时间窗: immediately after the procedure(injection)

After injection, the child will be asked to choose a face from the Wong-Baker faces pain rating scale to express his pain experience after explaining the scale to him (Scores from 0 to 10),The scale shows a series of faces ranging from a happy face at (0) which represents "no hurt", to a crying face at (10), which represents "hurts like the worst pain imaginable . "the higher score means a worse outcome"

次要结局

  • objective pain perception during local anesthesia injection(During the procedure (injection))
  • Subjective pain perception during the extraction(immediately after the procedure(extraction))
  • objective pain perception during extraction(During the procedure (extraction))
  • Physiological parameter (heart rate)(at baseline(10 minutes before the procedure) and during both procedures (injection and extraction))
  • Physiological parameter (oxygen saturation)(at baseline(10 minutes before the procedure) and during both procedures (injection and extraction))

研究者

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

Sara Mostafa Abohashim Masoud Soliman

Principal Investigator

Cairo University

相似试验