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NCT Number: NCT06623851

Digital Versus Conventional Impression on Discomfort and Dental Anxiety Among Preschoolers

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.

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Key information

Conditions

Dental Anxiety

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location status: Recruiting

Location contact

Arwa Ghoneim, BDS

CONTACT

[email protected]

01204666655

Arwa Gohneim, BDS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Intraoral scanner

Other
  • 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

Alginate impression

Other

Conventional impressions of both arches will be made according to the manufacturer's instructions, using steel impression trays and alginate

Primary outcomes

  1. Change in child discomfort

    Time frame: intraoperative

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

  2. Change in dental anxiety

    Time frame: 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.

Secondary outcomes

  1. Gag reflex

    Time frame: post procedure

    After taking the impressions, child's gag reflex will be assessed. Gag sensitivity is ranked on a scale from 1 (least severe) to 5 (most severe) using the Gagging Severity Index (GSI)

  2. Assessment of level of child cooperation

    Time frame: intraoperative

    Venham's Behavior rating scale classifies the child's behavior into 6 categories with scores ranging from 0 to 5. A score of 0 means total cooperation and a score of 5 refers to complete absence of compliance and cooperation and the requirement of physical restraint

  3. procedure time

    Time frame: intraoperative

    Time taken from scanning and taking impression for the lower and upper jaws to the final bite registeration. Time will be recorded in minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Arwa Ghoneim, BDS

CONTACT

[email protected]

01204666655

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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