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Digital Versus Conventional Impression on Discomfort and Dental Anxiety Among Preschoolers

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06623851
Enrollment
66
Registered
2024-10-02
Start date
2024-06-23
Completion date
2024-10-01
Last updated
2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety

Keywords

Dental impression, Digital impression

Brief summary

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.

Interventions

* 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

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

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in child discomfortintraoperativeChildren's discomfort will be evaluated using a 100-mm modified VAS index supported with facial emojis.
Change in dental anxietyintraoperativeDental 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

MeasureTime frameDescription
Gag reflexpost procedureAfter 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)
Assessment of level of child cooperationintraoperativeVenham'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
procedure timeintraoperativeTime taken from scanning and taking impression for the lower and upper jaws to the final bite registeration. Time will be recorded in minutes

Countries

Egypt

Contacts

Primary ContactArwa Ghoneim, BDS
arwaghoneim1992@gmail.com01204666655

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026