AccuracyNCT07209826
Evaluation of the Scanning Accuracy of Scanners Operating With Different Scanning Technologies in Mandibular and Maxillary Edentulous Ridges
A study testing Trios 5, iTero Lumina and Medit i700 in people with Accuracy and Measurement Reliability, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the scanning accuracy of scanners equipped with Active Triangulation, Confocal Microscopy, and Multi-Direct-Capture technologies. Department of Prosthetic Dentistry, Faculty of Dentistry, Ege University , 30 patients who applied for a complete removable denture and met the inclusion… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Accuracy, Measurement Reliability
- What is being tested?
- Trios 5, iTero Lumina and Medit i700
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 to 80
- Upper and lower edentulous ridges
- Individuals who have not received radiation therapy or chemotherapy
- Individuals who have not been diagnosed with dry mouth
- Individuals without active mouth sores due to systemic diseases
- Patients who accept the study conditions will be included in the study.
Who cannot join
- Patients whose extraction site has not yet healed or whose last tooth extraction was less than 2 months ago
- Individuals who have undergone radiation therapy and chemotherapy
- Individuals diagnosed with dry mouth
- Individuals with active mouth sores due to systemic diseases
- Patients who do not agree to the study conditions will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University,Faculty of Dentistry,Department of Prosthodontics,Izmir
Izmir
About this study
Official title: In Vivo Evaluation of the Scanning Accuracy of Scanners Operating With Different Scanning Technologies in Mandibular and Maxillary Edentulous Ridges
This study aims to evaluate the scanning accuracy of scanners equipped with Active Triangulation, Confocal Microscopy, and Multi-Direct-Capture technologies.
Department of Prosthetic Dentistry, Faculty of Dentistry, Ege University , 30 patients who applied for a complete removable denture and met the inclusion criteria will have conventional impressions taken. The resulting master model (reference scan) will be scanned using an industrial scanner with high scanning accuracy (E4 lab scanner, 3shape, Denmark) to obtain digital data. Edentulous ridges; Active Triangulation (Medit i700, Seoul, South Korea), Confocal Microscopy (Trios 5, Henry Schein Dental, Gillingham, Kent, UK), and Multi-Direct-Capture technologies (iTero Lumina, Align Technologies, San Jose, California, USA) will be scanned three times using the scanning protocols recommended by the manufacturers and digitized. All digital data obtained will be evaluated using Geomagic (Studio 2015; 3D Systems Inc., Darmstadt, Germany) 3D analysis software to match the reference data and verify its accuracy according to the accepted reference measurement.
Read the detailed description
At Ege University Faculty of Dentistry Department of Prosthodontics, Type 4 (hard) plaster will be used to obtain models by taking impressions with Type A silicone impression material from 30 patients undergoing treatment for lower and/or upper complete (total) dentures who meet the inclusion criteria for the study. The model will be scanned using an industrial EOS scanner (E4 lab scanner, 3shape, Denmark). Three digital scans will be taken from each patient using three different IOS scanners (Trios 5 (Henry Schein Dental, Gillingham, Kent, UK), Medit i700 (Seoul, South Korea), and iTero Lumina (Align Technologies, San Jose, California, USA)), with each patient scanned three times using each scanner. The obtained data will be evaluated with a 3D analysis software program (Geomagic Studio 2015; 3D Systems Inc., Darmstadt, Germany) to match the traditional plaster model (reference) data.
For normally distributed data, one-way ANOVA and post hoc Bonferroni test will be performed; for non-normally distributed data, Bonferroni and Kruskal-Wallis tests will be performed. Intergroup comparisons will be tested using the Tukey HSD test. All statistical analyses will be performed using statistical software (IBM SPSS Statistics, v22.0; IBM Corp., USA). It will be investigated whether there is a statistically significant difference in scanning accuracy between the three intraoral scanners.
The study will evaluate three different scanning technologies: Active Triangulation (Medit i700, Seoul, South Korea), Confocal Microscopy technologies (Trios 5, Henry Schein Dental, Gillingham, Kent, UK), and Multi-unit-capture technologies (iTero Lumina, Align Technologies, San Jose, California, USA). A review of the literature reveals that there are few studies evaluating scanners with different technologies in terms of scanning technologies. The aim of this study is to evaluate the accuracy of scanners with different scanning technologies in completely edentulous arches.
- Conditions
- Accuracy, Measurement Reliability
- Being tested
- Trios 5, iTero Lumina, Medit i700, E4 Lab Scanner
- Keywords
- intra-oral scanner, digital impression, Complete Edentulism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trios 5Other
Each patient's edentulous ridges are planned to be scanned three times with Trios 5.To ensure optimum accuracy, scans were performed in a standard dark environment in accordance with the manufacturer's scanning protocols.
iTero LuminaOther
Each patient's edentulous ridges are planned to be scanned three times with iTero Lumina.To ensure optimum accuracy, scans were performed in a standard dark environment in accordance with the manufacturer's scanning protocols.
Medit i700Other
Each patient's edentulous ridges are planned to be scanned three times with Medit i700.To ensure optimum accuracy, scans were performed in a standard dark environment in accordance with the manufacturer's scanning protocols.
E4 Lab ScannerOther
Conventional measurements will be taken from each patient, and the resulting master model (reference scan) will be scanned using an industrial scanner with high scanning accuracy (E4 lab scanner, 3shape, Denmark) to obtain digital data.
| Study group | Role | What they receive |
|---|---|---|
| Trios 5 Intra-oral scanner | Experimental | It is an intraoral scanner that works with confocal microscopy scanning technology. The purpose of using the intraoral scanner in our work is to take intraoral digital measurements by scanning edentulous ridges. They record the patient's intraoral images in high resolution. Receives: Other: iTero Lumina; Other: Medit i700; Other: E4 Lab Scanner |
| Medit i700 Intra-oral Scanner | Experimental | It is an intraoral scanner that works with active triangulation scanning technology. In our study, the purpose of using the intraoral scanner is to take intraoral digital measurements by scanning edentulous ridges. They record the patient's intraoral images in high resolution. Receives: Other: Trios 5; Other: iTero Lumina; Other: E4 Lab Scanner |
| iTero Lumina Intra-oral Scanner | Experimental | It is an intraoral scanner that works with multi-unit-capture scanning technology. In this study, using the new generation digital scanning technology of iTero Lumina, intraoral digital measurements are taken by scanning edentulous ridges. They record the patient's intraoral images in high resolution. Receives: Other: Trios 5; Other: Medit i700; Other: E4 Lab Scanner |
| E4 Lab Scanner Extra-oral Scanner | Active comparator | The 3Shape E4 laboratory scanner (EOS) is a desktop laboratory scanner with an indirect scanning procedure. It features fast and accurate scanning technology. With 3Shape E4 scanners, the scanning process begins as soon as you place the model inside the scanner. It records the digital measurement data of the model.
In our study, the primary model (reference scan) obtained by taking conventional measurements from the patient is scanned using a laboratory scanner, and digital data is obtained. Receives: Other: Trios 5; Other: iTero Lumina; Other: Medit i700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Intraoral Scanners Compared With Reference Extraoral Scanner
The primary outcome is the trueness (accuracy) of three intraoral scanners (Trios 5, Medit i700, iTero Lumina) in capturing edentulous maxillary and mandibular arches. Accuracy will be assessed by comparing the surface deviation of intraoral scan data to the reference dataset obtained from the extraoral laboratory scanner of a conventional stone cast. Mean root-mean-square (RMS) error values (measured in micrometers, µm) will be calculated for each scanner relative to the reference to quantify the deviation.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start10 Apr 2025
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AccuracyStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Sule NAZLIGUL, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209826
- Sponsor's protocol ID
- Ege-DHF-ASN-01
- Status last verified
- Apr 2025
- First submitted
- 30 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Evaluation of the Scanning Accuracy of Scanners Operating With Different Scanning Technologies in Mandibular and Maxillary Edentulous Ridges
- ClinicalTrials.gov ID
- NCT07209826
- Acronym / sponsor ID
- Ege-DHF-ASN-01
- Conditions
- Accuracy, Measurement Reliability
- Keywords
- intra-oral scanner, digital impression, Complete Edentulism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 7 Oct 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.
This study aims to evaluate the scanning accuracy of scanners equipped with Active Triangulation, Confocal Microscopy, and Multi-Direct-Capture technologies.
Department of Prosthetic Dentistry, Faculty of Dentistry, Ege University , 30 patients who applied for a complete removable denture and met the inclusion criteria will have conventional impressions taken. The resulting master model (reference scan) will be scanned using an industrial scanner with high scanning accuracy (E4 lab scanner, 3shape, Denmark) to obtain digital data. Edentulous ridges; Active Triangulation (Medit i700, Seoul, South Korea), Confocal Microscopy (Trios 5, Henry Schein Dental, Gillingham, Kent, UK), and Multi-Direct-Capture technologies (iTero Lumina, Align Technologies, San Jose, California, USA) will be scanned three times using the scanning protocols recommended by the manufacturers and digitized. All digital data obtained will be evaluated using Geomagic (Studio 2015; 3D Systems Inc., Darmstadt, Germany) 3D analysis software to match the reference data and verify its accuracy according to the accepted reference measurement.
Detailed description
At Ege University Faculty of Dentistry Department of Prosthodontics, Type 4 (hard) plaster will be used to obtain models by taking impressions with Type A silicone impression material from 30 patients undergoing treatment for lower and/or upper complete (total) dentures who meet the inclusion criteria for the study. The model will be scanned using an industrial EOS scanner (E4 lab scanner, 3shape, Denmark). Three digital scans will be taken from each patient using three different IOS scanners (Trios 5 (Henry Schein Dental, Gillingham, Kent, UK), Medit i700 (Seoul, South Korea), and iTero Lumina (Align Technologies, San Jose, California, USA)), with each patient scanned three times using each scanner. The obtained data will be evaluated with a 3D analysis software program (Geomagic Studio 2015; 3D Systems Inc., Darmstadt, Germany) to match the traditional plaster model (reference) data.
For normally distributed data, one-way ANOVA and post hoc Bonferroni test will be performed; for non-normally distributed data, Bonferroni and Kruskal-Wallis tests will be performed. Intergroup comparisons will be tested using the Tukey HSD test. All statistical analyses will be performed using statistical software (IBM SPSS Statistics, v22.0; IBM Corp., USA). It will be investigated whether there is a statistically significant difference in scanning accuracy between the three intraoral scanners.
The study will evaluate three different scanning technologies: Active Triangulation (Medit i700, Seoul, South Korea), Confocal Microscopy technologies (Trios 5, Henry Schein Dental, Gillingham, Kent, UK), and Multi-unit-capture technologies (iTero Lumina, Align Technologies, San Jose, California, USA). A review of the literature reveals that there are few studies evaluating scanners with different technologies in terms of scanning technologies. The aim of this study is to evaluate the accuracy of scanners with different scanning technologies in completely edentulous arches.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Trios 5 Intra-oral scanner | Experimental | Other: iTero Lumina, Other: Medit i700, Other: E4 Lab ScannerIt is an intraoral scanner that works with confocal microscopy scanning technology. The purpose of using the intraoral scanner in our work is to take intraoral digital measurements by scanning edentulous ridges. They record the patient's intraoral images in high resolution. |
| Medit i700 Intra-oral Scanner | Experimental | Other: Trios 5, Other: iTero Lumina, Other: E4 Lab ScannerIt is an intraoral scanner that works with active triangulation scanning technology. In our study, the purpose of using the intraoral scanner is to take intraoral digital measurements by scanning edentulous ridges. They record the patient's intraoral images in high resolution. |
| iTero Lumina Intra-oral Scanner | Experimental | Other: Trios 5, Other: Medit i700, Other: E4 Lab ScannerIt is an intraoral scanner that works with multi-unit-capture scanning technology. In this study, using the new generation digital scanning technology of iTero Lumina, intraoral digital measurements are taken by scanning edentulous ridges. They record the patient's intraoral images in high resolution. |
| E4 Lab Scanner Extra-oral Scanner | Active comparator | Other: Trios 5, Other: iTero Lumina, Other: Medit i700The 3Shape E4 laboratory scanner (EOS) is a desktop laboratory scanner with an indirect scanning procedure. It features fast and accurate scanning technology. With 3Shape E4 scanners, the scanning process begins as soon as you place the model inside the scanner. It records the digital measurement data of the model. In our study, the primary model (reference scan) obtained by taking conventional measurements from the patient is scanned using a laboratory scanner, and digital data is obtained. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals aged 18 to 80
- Upper and lower edentulous ridges
- Individuals who have not received radiation therapy or chemotherapy
- Individuals who have not been diagnosed with dry mouth
- Individuals without active mouth sores due to systemic diseases
Key exclusion criteria (5 listed)
- Patients whose extraction site has not yet healed or whose last tooth extraction was less than 2 months ago
- Individuals who have undergone radiation therapy and chemotherapy
- Individuals diagnosed with dry mouth
- Individuals with active mouth sores due to systemic diseases
- Patients who do not agree to the study conditions will not be included in the study.
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 |
|---|---|---|
| Trios 5Each patient's edentulous ridges are planned to be scanned three times with Trios 5.To ensure optimum accuracy, scans were performed in a standard dark environment in accordance with the manufacturer's scanning protocols. | Other | E4 Lab Scanner Extra-oral Scanner, Medit i700 Intra-oral Scanner, iTero Lumina Intra-oral Scanner |
| iTero LuminaEach patient's edentulous ridges are planned to be scanned three times with iTero Lumina.To ensure optimum accuracy, scans were performed in a standard dark environment in accordance with the manufacturer's scanning protocols. | Other | E4 Lab Scanner Extra-oral Scanner, Medit i700 Intra-oral Scanner, Trios 5 Intra-oral scanner |
| Medit i700Each patient's edentulous ridges are planned to be scanned three times with Medit i700.To ensure optimum accuracy, scans were performed in a standard dark environment in accordance with the manufacturer's scanning protocols. | Other | E4 Lab Scanner Extra-oral Scanner, Trios 5 Intra-oral scanner, iTero Lumina Intra-oral Scanner |
| E4 Lab ScannerConventional measurements will be taken from each patient, and the resulting master model (reference scan) will be scanned using an industrial scanner with high scanning accuracy (E4 lab scanner, 3shape, Denmark) to obtain digital data. | Other | Medit i700 Intra-oral Scanner, Trios 5 Intra-oral scanner, iTero Lumina Intra-oral Scanner |
Primary outcome
Accuracy of Intraoral Scanners Compared With Reference Extraoral Scanner
Time frame: Two months
The primary outcome is the trueness (accuracy) of three intraoral scanners (Trios 5, Medit i700, iTero Lumina) in capturing edentulous maxillary and mandibular arches. Accuracy will be assessed by comparing the surface deviation of intraoral scan data to the reference dataset obtained from the extraoral laboratory scanner of a conventional stone cast. Mean root-mean-square (RMS) error values (measured in micrometers, µm) will be calculated for each scanner relative to the reference to quantify the deviation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
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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 Trios 5, iTero Lumina and Medit i700 in people with Accuracy and Measurement Reliability, run by Ege 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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Accuracy of Intraoral Scanners Compared With Reference Extraoral Scanner (time frame: Two months). 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 Oct 2025.