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).
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
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.
- Conditions
- Intraoral Scanner
- 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 group | Role | What they receive |
|---|---|---|
| Digital scanner group | Experimental | 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. Receives: Device: Intraoral Scanners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences Between Genders in Children's Responses During Measurements Made with the IteroTM
Measured: 15 minutes
Secondary outcomes (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.
- First posted4 Mar 2025
- Study start1 Nov 2024
- Primary completion15 Jan 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoral ScannerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Batman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursezen Kavasoglu, Batman University
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoral Scanners in Terms of Comfort in Pediatric Patients: A Crossover Randomized Trial
- ClinicalTrials.gov ID
- NCT06857721
- Acronym / sponsor ID
- RCT-CS / NK01
- Conditions
- Intraoral Scanner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Batman UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital scanner group | Experimental | Device: Intraoral ScannersIt 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children Children have no experience with dental measurement techniques or intraoral scanning.
Key exclusion criteria (1 listed)
- Children with craniofacial syndromes Children with systemic diseases Children with Behavioral problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoral ScannersIntraoral scanners for pediatric patients | Device | Digital scanner group |
Primary outcome
Differences Between Genders in Children's Responses During Measurements Made with the IteroTM
Time frame: 15 minutes
1 secondary outcome
Differences Between Genders in Children's Responses During Measurements Made with the 3ShapeTM
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.