Intra Oral Scanning of Edentulous Arches

Completed

• Conditions: Edentulous Jaw
• Interventions: Diagnostic Test: digital impression

• Registration Number: NCT06146153
• Lead Sponsor: October University for Modern Sciences and Arts

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.

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2023-11-18
• Study First Submitted QC: 2023-11-18
• Study First Posted: 2023-11-24
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Exclusion criteria included: 1. Presence of any remaining teeth; 2. Inability to comprehend the study's objectives and procedures; 3. Palatal defect or lesion; 4. Postoperative scarring on the palate; 5. Limitations in mouth opening.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Class I	digital impression	(medium U-vault)
Class III	digital impression	flat vault
Class II	digital impression	(deep-vault)

Primary Outcome Measures

Name	Time	Method
Trueness	15 days	Trueness 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 Outcome Measures

Name	Time	Method
precision	15 days	Precision, 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

Trial Locations

Locations (1)

MSA University; 🇪🇬 Giza, Egypt