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NCT Number: NCT07209826

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Accuracy Measurement Reliability

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University,Faculty of Dentistry,Department of Prosthodontics,Izmir

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trios 5

Other

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 Lumina

Other

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 i700

Other

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 Scanner

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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