跳至主要内容
临床试验/NCT06623851
NCT06623851招募中不适用

Effectiveness of Digital Versus Conventional Impression on Discomfort and Dental Anxiety in Preschool Children (A Randomized Controlled Clinical Trial)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年6月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
66
试验地点
1
主要终点
Change in child discomfort

研究概览

简要总结

Background: Taking alginate impressions for preschoolers is challenging and might be disturbing for them. Therefore, intraoral scanners are suggested as a better alternative to the conventional alginate impression.

Objectives: The present study aims to evaluate and compare the level of patients' discomfort, dental anxiety, gag reflex, behavior and time required for taking alginate impressions with that of intraoral scanning.

Materials and methods: The study will be a randomized, controlled clinical trial, parallel design. A total of 666 pediatric dental patients aged from 4-6 years will be selected from the outpatient clinic of the of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University. Participants will be allocated into 2 groups. Children in the first group will receive digital impressions by an intraoral scanner, while those of the second group will receive conventional alginate impressions. Patients' discomfort will be evaluated by a modified VAS index supported with emojis. Dental anxiety will be evaluated using Facial Image Scale (FIS). Gag reflex will be assessed by Gag Severity Index (GSI). Child's behavior towards the impression technique in the 2 groups will be evaluated using Venham's Behavior rating scale. Time taken to complete the procedures will be recorded using a digital stopwatch.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Children with scores of 3 or 4 during preoperative assessments according to the Frankl Behavioral Rating Scale.
  • •No previous dental experience.
  • •Patient's parents signed an informed consent before participating in the trial.

排除标准

  • •Any physical or mental disability, or psychological problems.
  • •Children with temporomandibular joint or periodontal discomfort

研究组 & 干预措施

Digital dental Impression

Experimental

干预措施: Intraoral scanner (Other)

Conventional dental impression

Active Comparator

干预措施: Alginate impression (Other)

结局指标

主要结局

Change in child discomfort

时间窗: intraoperative

Children's discomfort will be evaluated using a 100-mm modified VAS index supported with facial emojis.

Change in dental anxiety

时间窗: intraoperative

Dental anxiety will be recorded using the Facial Image Scale (FIS) Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling.

次要结局

  • Gag reflex(post procedure)
  • Assessment of level of child cooperation(intraoperative)
  • procedure time(intraoperative)

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant Lecturer of Dental Public Health and biostatistical consultanat

Alexandria University

研究点 (1)

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