Comfort Assessment of Intraoral Scanners in Children (RCT-CS)

Evaluation of Intraoral Scanners in Terms of Comfort in Pediatric Patients: A Crossover Randomized Trial

With the advancement of the digital age, dentistry has been one of the fields that has benefited most from technological innovations. Among these advancements, digital intraoral scanners, which precisely capture the three-dimensional geometry of objects, have become widely used, particularly in prosthodontics and orthodontics. The increasing integration of digitalization in pediatric dentistry has also improved treatment processes, making them more efficient and comfortable for both patients and clinicians.

Previous studies comparing conventional and digital impression techniques suggest that patients generally prefer digital scanning due to improved comfort and reduced procedural time. However, research on pediatric patients remains limited, with most studies focusing on general performance rather than specific patient experiences. Given the unique anatomical and psychological characteristics of children, a comprehensive evaluation of comfort perception in different intraoral scanners is necessary.

This study aims to assess the effects of two different intraoral scanners on pediatric patients' comfort perception. It is designed as a single-center, randomized controlled crossover study, approved by the Ethics Committee of the Faculty of Dentistry at Batman University. A total of 68 children meeting the inclusion criteria were recruited and randomly assigned to undergo intraoral scanning with two different devices (IteroTM and 3ShapeTM) at separate visits. Comfort levels were assessed using the Animale Emoji Scale (AES), a validated tool for measuring children's emotional responses to procedures.

By comparing the comfort perception of different intraoral scanners in pediatric patients, this study aims to provide evidence-based guidance for clinicians in selecting the most patient-friendly digital impression techniques, ultimately improving patient experience and clinical workflow in pediatric dentistry.

To prevent bias during the procedure, the intraoral scan was performed using either the Itero™ or 3Shape™ device, determined by simple randomization. Since the sample consisted of consecutive cases, random selection was performed by coin toss.

At the first appointment, parents or legal guardians were informed about the study, a consent form was provided, and they were informed that they would be contacted again if they wished to participate. The first scan was performed using the Itero Element 2D (Align Technology, San Jose, CA, USA) device.

The second appointment was scheduled 7 to 30 days after the initial appointment to avoid affecting children's comfort, in accordance with previous studies. The second scan was planned using the 3Shape Trios 3 (3Shape, Copenhagen, Denmark) device.

All intraoral scans were performed by the principal investigator of the study. According to the manufacturer's instructions, the patient was scanned in a supine position following the same sequence (lower jaw, upper jaw, and bite registration).

To increase the reliability of the results, all measurements were taken by a single experienced researcher who took at least 100 measurements with both scanning devices. To ensure standardization, all patients were positioned at 11 o'clock relative to the unit and the scanning device was positioned at 1 o'clock for all scans.

The primary outcome of the study was patient comfort. Participants' comfort was measured using the Animated Emoji Scale (AES) based on questions prepared during the procedure. Children were asked to select the face that best reflected their feelings after the procedure (Figure 1). For younger children, the AES scale was completed under the supervision of the operator and with guiding questions. The AES scale includes 6 different facial expressions ranging from "no pain" to "worst pain," and each face is scored from 0-2-4-6-8-10. These measurements were always taken by the same observer.

Sample size was calculated using G*Power, and data analysis was performed using IBM SPSS 21® Software (Armonk, NY, USA). The normality of the data was evaluated using the Shapiro-Wilk's and/or Kolmogorov Smirnov tests. The significance level was set at p<0.05. In case of deviation from the normal distribution, differences between groups were examined using the Mann Whitney U and Kruskal Wallis-H tests. In case of a significant difference in the Kruskal Wallis-H test, a Post-Hoc multiple comparison test was applied. Differences between two dependent variables were analyzed using the Wilcoxon test.

Study Overview

• Status: Completed
• Conditions: Intraoral Scanner
• Intervention / Treatment: Device: Intraoral Scanners

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Diyarbakir, Turkey, 21070
    • Dental In Oral and Dental Health Polyclinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Healthy children Children have no experience with dental measurement techniques or intraoral scanning.

Exclusion Criteria:

Children with craniofacial syndromes Children with systemic diseases Children with Behavioral problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital scanner group; It consists of children whose digital measurements were taken with the Itero scanner in the first appointment and with the 3Shape scanner in the second appointment.	Device: Intraoral Scanners; Intraoral scanners for pediatric patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Differences Between Genders in Children's Responses During Measurements Made with the IteroTM	15 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Differences Between Genders in Children's Responses During Measurements Made with the 3ShapeTM	15 minutes

Collaborators and Investigators

• Sponsor: Batman University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): February 15, 2025

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NK01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: only IPD used in the results publication
• IPD Sharing Time Frame: Start Date: 04.2025 End Date: 07.2025
• IPD Sharing Access Criteria: Dentists
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No