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临床试验/NCT07156032
NCT07156032尚未招募不适用

Evaluation of the Effect of Computer Controlled Starpen Automatic Injection Device Versus Conventional Syringe on Pain Perception During Infiltration Anesthesia and Extraction of Maxillary Primary Molars : A Randomized Clinical Trial

Cairo University0 个研究点目标入组 38 人开始时间: 2026年1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
38
主要终点
Subjective pain during injection

研究概览

简要总结

To evaluate the effect of Starpen device on pain perception during anesthesia and extraction of maxillary primary molars.

详细描述

After enrollment of the patients according to the eligibility criteria, taking full medical , dental history and informed consents from the parents. Clinical and radiographic examination will be done for the tooth to be extracted. A diagnostic chart with personal, medical and dental history will be filled out . Also preoperative psychological management of the child through positive reinforcement techniques should be done . Then the two parallel groups will have local anesthesia using an infiltration technique in the upper jaw ; one group with conventional syringe and the other group by Starpen automatic injection device . Both groups will have the site of injection well prepared before injection by the same way and technique. In Addition, procedures as anesthesia injection and extraction will be done according to the guidelines set by the American Academy of Pediatric Dentistry . After the procedure is done , the participants and their parents will be instructed about post-operative care and the need of a space maintainer will be taken into account. Moreover subjective and objective pain will be assessed and scored during procedure of anesthesia injection and extraction.

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
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
否

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 mentally capable of communication
  • •First dental visit
  • •Patient requiring extraction of upper primary molars due to root caries , crown fractures, periapical disease and failed pulpotomies
  • •No acute dental pain

排除标准

  • •Children with a behavioral management problem
  • •Parental refusal of participation
  • •Children with 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 the root
  • •Acute dental pain

研究组 & 干预措施

Starpen automatic injection device

Experimental

effect of computer controlled Starpen device on pain perception during infiltration anesthesia and extraction of maxillary primary molars

干预措施: Starpen automatic injection device (Device)

Conventional syringe

Active Comparator

Conventional syringe on pain perception during infiltration anesthesia and extraction of maxillary primary molars

干预措施: conventional syringe (Procedure)

结局指标

主要结局

Subjective pain during injection

时间窗: during procedure

Subjective pain perception during injection of infiltration anesthesia using Wong Baker Scale which represents a series of faces from 0-value happy face that represents lack of pain to a 10-value crying face which represents the worst possible face . On this basis , the patient chooses the face that best describes his/her level of pain.

次要结局

  • Objective pain during infiltration(during procedure)
  • Subjective pain during extraction(during procedure)
  • Objective pain during extraction(during procedure)
  • Physiological parameters ( heart rate )(Readings will be taken before and during anesthesia injection and during extraction.)
  • Physiological parameter ( oxygen saturation)(Readings will be taken before and during anesthesia injection and during extraction.)

研究者

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

Ghadeer Mohamed Sayed

Principal Investigator

Cairo University

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