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NCT Number: NCT07740798

Trueness of Intra-Oral Scanners Compared to an Extra-Oral Scanner for Scanning of Mandibular Edentulous Impressions

the relative accuracy of different intraoral scanner types specifically for capturing the complex morphology of edentulous arches, including peripheral borders and mobile tissues, remains an area of investigation, with conflicting reports in the literature.

The purpose of this study is to compare the accuracy of different intraoral scanners with a laboratory scanner for digitizing impressions of edentulous mandible.

Completely edentulous patients will be gathered; final impressions will be taken for them using zinc oxide & eugenol impression material then they will be scanned with intra oral and extra oral scanners for indirect digitalization.

Scans will be superimposed and compared using a software program for analysis for accuracy in the form of trueness

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

completely edentulous patients will be recruited.

Study procedures:

Custom trays will be fabricated and checked for extension, and then definitive impressions will be made with type-1 low fusing impression compound (Tracing sticks; Kemdent, UK) for border molding and zinc oxide eugenol impression paste (Cavex Holland B.N) for the impression. Reference markers will be placed on the impressions in anterior and posterior ridge areas.

The indirect digitalization of impressions will be made with two different Intraoral scanning devices and a laboratory scanner.

  • Intra oral scanners are:
  • Aoralscan (Shining 3D Tech. Co., Ltd. Hangzhou, China): structured light-optical triangulation technology.
  • MEDIT i600 (Medit Corp. Seoul, South Korea): structured light-3d-in-motion video technology.
  • Extra oral scanner: UP3D. Scans will be exported as standard tessellation language (STL) files. The STL files then will be compared using a 3D analysis software program for analysis.

For "trueness" measurements every STL file of each experimental group will be superimposed to the extra oral scan.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • edentulous patients
  • last teeth extraction 6 months before the impression procedures

Exclusion criteria

  • un cooperative patients
  • Neuromotor disorders
  • Parkinsonism
  • Tremors

Treatment and study plan

Digital impression of the mandibular edentulous arch

Other

Digital impression of the mandibular edentulous arch will be made by MEDIT i600 scanner (Medit Corp. Seoul, South Korea) followed by another digital impression of the same arch using Aoralscan scanner (Shining 3D Tech. Co., Ltd. Hangzhou, China). Both impressions will be compared to each other in terms of trueness.

Primary outcomes

  1. trueness assessment of impression techniques for mandibular edentulous arches

    Time frame: 3 months

    Assessment of trueness of Digital impression of the mandibular edentulous arch using intra oral scanner will be made by MEDIT i600 scanner (Medit Corp. Seoul, South Korea) followed by another digital impression of the same arch using Aoralscan scanner (Shining 3D Tech. Co., Ltd. Hangzhou, China). Both impressions will be compared to each other in terms of trueness in relation to desktop scanner

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mohamed, MD

CONTACT

[email protected]

01111191337

Ahmed Mohamed, MD

CONTACT

[email protected]

01111191337

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

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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