Digital Versus Conventional Impression on Discomfort and Dental Anxiety Among Preschoolers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-23

Study Completion Date

2024-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Acceptability of Digital Impression Compared to Conventional Technique in Children

NCT07002138

Dental Anxiety Gagging Dental Impression Techniques +1 more

COMPLETED NA

Comparative Evaluation of Pediatric Patient Comfort, Time, and Preference Between Digital Scans and Rubber Base Impressions. Crossover Study Randomized Controlled Trial

NCT06833385

Pediatric Patient With Early Loss of Primary Teeth

ACTIVE_NOT_RECRUITING NA

Dental Anxiety Among Children Pre and Post COVID 19 Pandemic

NCT04815759

Dental Anxiety

UNKNOWN

Comparing Dental Impression Methods for Children

NCT06422611

Dental Impression, Pediatric Dentistry, Satisfaction

COMPLETED

Dental Game Impact on Kids' Pulpotomy Pain and Anxiety

NCT07072559

Pulpotomies Primary Teeth Anxiety Pain

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Digital dental Impression

Group Type EXPERIMENTAL

Intraoral scanner

Intervention Type 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

Conventional dental impression

Group Type ACTIVE_COMPARATOR

Alginate impression

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Alginate impression

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.