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Intraoral ScannerRCT-CSNCT06857721

Comfort Assessment of Intraoral Scanners in Children

A study testing Intraoral Scanners in people with Intraoral Scanner, run by Batman University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Intraoral Scanner
What is being tested?
Intraoral Scanners
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2024to 15 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Dental In Oral and Dental Health Polyclinic

    Diyarbakır, 21070

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Being tested
Intraoral Scanners

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraoral ScannersDevice

    Intraoral scanners for pediatric patients

Study groups in NCT06857721
Study groupRoleWhat they receive
Digital scanner groupExperimentalIt 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.
Receives: Device: Intraoral Scanners

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences Between Genders in Children's Responses During Measurements Made with the IteroTM

    Measured: 15 minutes

Secondary outcomes (1)
  1. Differences Between Genders in Children's Responses During Measurements Made with the 3ShapeTM

    Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2025
  2. Study start1 Nov 2024
  3. Primary completion15 Jan 2025
  4. Study completion15 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06857721
Sponsor's protocol ID
NK01
Acronym
RCT-CS
Status last verified
Mar 2025
First submitted
27 Feb 2025
Last updated
7 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: only IPD used in the results publication

Questions about this trial

What is this clinical trial studying?

A study testing Intraoral Scanners in people with Intraoral Scanner, run by Batman University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences Between Genders in Children's Responses During Measurements Made with the IteroTM (time frame: 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.

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