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Digital Versus Conventional Impression on Discomfort and Dental Anxiety Among Preschoolers

ConditionDental Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorHams Hamed Abdelrahman

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Any physical or mental disability, or psychological problems.

Children with temporomandibular joint or periodontal discomfort

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intraoral scanner

    Other intervention

    * 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 intervention

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

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Digital dental ImpressionExperimental treatment 1 intervention
Group B: Conventional dental impressionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in child discomfort

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

Time frame
intraoperative
2

Change in dental anxiety

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.

Time frame
intraoperative

Secondary outcomes

1

Gag reflex

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)

Time frame
post procedure
2

Assessment of level of child cooperation

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

Time frame
intraoperative
3

procedure time

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

Time frame
intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hams Hamed Abdelrahman

Lead sponsor

Alexandria University

Sponsor institution

Source ClinicalTrials.gov
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