Trueness of Intra-Oral Scanners Compared to an Extra-Oral Scanner for Scanning of Mandibular Edentulous Impressions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital impression of the mandibular edentulous arch.
- Who it may be relevant to
- Registry conditions: Edentulous Jaw. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed description
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:
1. Aoralscan (Shining 3D Tech. Co., Ltd. Hangzhou, China): structured light-optical triangulation technology. 2. 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.
Interventions
- Other Digital impression of the mandibular edentulous arch
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 outcome measures
- trueness assessment of impression techniques for mandibular edentulous arches [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- edentulous patients
- last teeth extraction 6 months before the impression procedures
Exclusion criteria
- un cooperative patients
- Neuromotor disorders
- Parkinsonism
- Tremors
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07740798 · OOC-8-25-6