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Evaluation of the Scanning Accuracy of Scanners Operating With Different Scanning Technologies in Mandibular and Maxillary Edentulous Ridges

In Vivo Evaluation of the Scanning Accuracy of Scanners Operating With Different Scanning Technologies in Mandibular and Maxillary Edentulous Ridges

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07209826
Enrollment
30
Registered
2025-10-07
Start date
2025-04-10
Completion date
2026-02-28
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accuracy, Measurement Reliability

Keywords

intra-oral scanner, digital impression, Complete Edentulism

Brief 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 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.

Interventions

OTHERiTero Lumina

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.

OTHERTrios 5

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.

OTHERMedit i700

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.

OTHERE4 Lab Scanner

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.

Sponsors

Ege University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of Intraoral Scanners Compared With Reference Extraoral ScannerTwo monthsThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026