- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Mohamed, MD
- Phone Number: 01111191337
- Email: ahmedmostafa@dent.asu.edu.eg
Study Contact Backup
- Name: Ahmed Mohamed, MD
- Phone Number: 01111191337
- Email: ahmedmohameddodo85@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- edentulous patients
- last teeth extraction 6 months before the impression procedures
Exclusion Criteria:
- un cooperative patients
- Neuromotor disorders
- Parkinsonism
- Tremors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Root mean square of trueness in m.m will be reported.
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OOC-8-25-6
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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