NCT06623851

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 25, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
Last Updated

October 2, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

July 25, 2024

Last Update Submit

October 1, 2024

Conditions

Dental Anxiety

Keywords

Dental impressionDigital impression

Outcome Measures

Primary Outcomes (2)

  • Change in child discomfort

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

    intraoperative

  • 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.

    intraoperative

Secondary Outcomes (3)

  • Gag reflex

    post procedure

  • Assessment of level of child cooperation

    intraoperative

  • procedure time

    intraoperative

Study Arms (2)

Digital dental Impression

EXPERIMENTAL
Other: Intraoral scanner

Conventional dental impression

ACTIVE COMPARATOR
Other: Alginate impression

Interventions

Intraoral scannerOTHER

* 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

Digital dental Impression
Alginate impressionOTHER

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

Conventional dental impression

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

RECRUITING

Central Study Contacts

Arwa Ghoneim, BDS

CONTACT

01204666655arwaghoneim1992@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

First Submitted

July 25, 2024

First Posted

October 2, 2024

Study Start

June 23, 2024

Primary Completion

September 29, 2024

Study Completion

October 1, 2024

Last Updated

October 2, 2024

Record last verified: 2024-10

Locations

EG(1)