Intra Oral Scanning of Edentulous Arches

NCT ID: NCT06146153

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-01-15

Brief Summary

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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

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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

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Edentulous Jaw

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Class I

(medium U-vault)

digital impression

Intervention Type DIAGNOSTIC_TEST

intra oral scanning

Class II

(deep-vault)

digital impression

Intervention Type DIAGNOSTIC_TEST

intra oral scanning

Class III

flat vault

digital impression

Intervention Type DIAGNOSTIC_TEST

intra oral scanning

Interventions

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digital impression

intra oral scanning

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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October University for Modern Sciences and Arts

OTHER

Sponsor Role lead

Responsible Party

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Dina ElAwady

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina Elawady, A.Prof

Role: PRINCIPAL_INVESTIGATOR

MSA University

Locations

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MSA University

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MSA University

Identifier Type: -

Identifier Source: org_study_id

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