Digital Versus Conventional Impression on Discomfort and Dental Anxiety Among Preschoolers

Официальное название

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

Обзор

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.

Вмешательства

• Другое Intraoral scanner
  * The digital impressions will be made with the intraoral scanner following the procedure reported by the manufacturer. * The intraoral scanning process is divided into the lower jaw scan, upper jaw scan, and bite scan stages
• Другое Alginate impression
  Conventional impressions of both arches will be made according to the manufacturer's instructions, using steel impression trays and alginate

Первичные конечные точки

• Change in child discomfort [Срок оценки: intraoperative]
• Change in dental anxiety [Срок оценки: intraoperative]

Вторичные конечные точки (3)

• Gag reflex [Срок оценки: post procedure]
• Assessment of level of child cooperation [Срок оценки: intraoperative]
• procedure time [Срок оценки: intraoperative]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Египет · 1 центр

• Alexandria Faculty of Dentistry — Alexandria

Публикации

• Ghoneim AM, Dowidar KML, Talaat DM. Effectiveness of Digital Versus Conventional Impression on Discomfort and Dental Anxiety in Preschool Children (Randomised Controlled Clinical Trial). Int J Paediatr Dent. 2026 Jul;36(4):540-548. doi: 10.1111/ipd.70088. Epub 2026 Mar 31. PMID 41917676

Идентификаторы

NCT: NCT06623851 · 0863-2/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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