Skip to content

Intra Oral Scanning of Edentulous Arches

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06146153
Enrollment
30
Registered
2023-11-24
Start date
2023-11-01
Completion date
2024-01-15
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Jaw

Brief 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.

Interventions

DIAGNOSTIC_TESTdigital impression

intra oral scanning

Sponsors

October University for Modern Sciences and Arts
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* 1\. Full tooth loss in the maxilla; 2. Absence of infectious diseases; 3. Systemic good health; 4. Age between 50 and 75 years; 5. Willingness to cooperate throughout the data collection process

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Trueness15 daysTrueness is the degree of agreement between the digital impression and the reference scan. To assess trueness, we will measure the deviation between the reference and scanned files

Secondary

MeasureTime frameDescription
precision15 daysPrecision, is a statistical measure that quantifies the level of similarity between repeated samples within the same group. In the context of this study, the IOS impression STL files will be compared to each other in a manner similar to the previous comparisons

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026