Clinical Trials Directory

Trials / Completed

CompletedNCT06146153

Intra Oral Scanning of Edentulous Arches

Impact of Various Palatal Vault Configurations of Edentulous Arches on Scan Accuracy. An Invivo Clinical Study

Status
Completed
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
October University for Modern Sciences and Arts · Academic / Other
Sex
All
Age
50 Years – 75 Years
Healthy volunteers
Accepted

Summary

the aim of this study is to compare the influence of different palatal vault configurations on the accuracy and scan speed of IO scans in cases of completely edentulous arches. The null hypothesis is that there is no difference in scanning time, and trueness and precision of IO scans between class I, II and III palatal vault configurations.

Detailed description

A reference model will be created for each of the three groups with different palatal vault configurations. PVS material (DMG Silagum, Germany) will be used for impressions in a one-step process by an experienced operator, and type IV plaster (Heraeus, Germany) will be used to produce the models. These models will then bedigitized by an experienced operator using an extraoral scanner (Trios 3; 3Shape, Copenhagen, Denmark). The STL scan file of the maxillary model will be imported into CAD software (Meshmixer; Autodesk, San Rafael, CA, USA) to generate a reference file. Reference markers will then be added to the digital files to aid the superimposition process during digital subtraction operations.For intraoral scans, the entire maxilla of each patient will be digitally captured using an intraoral scanner (TRIOS POD, 3Shape, Copenhagen, Denmark).According to ISO standards, specifically ISO 5725-1, the accuracy of digital impressions obtained with intraoral scanners (IOS) will be evaluated according to two main parameters: trueness and precision.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTdigital impressionintra oral scanning

Timeline

Start date
2023-11-01
Primary completion
2024-01-01
Completion
2024-01-15
First posted
2023-11-24
Last updated
2024-04-02

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06146153. Inclusion in this directory is not an endorsement.