Accuracy of CBCT Imaging and Intraoral Scanner in Dental Plaster Casts Digitization: A Validity and Reliability Study

April 17, 2023 updated by: Mahmoud Sayed Badry, Cairo University
The Objective of this study is to evaluate the accuracy of CBCT and intraoral scanner, in digitization of dental plaster casts, by comparing them to desktop optical scanner as a gold standard.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The Objective of this study is to evaluate the accuracy of CBCT and intraoral scanner, in digitization of dental plaster casts, by comparing them to desktop optical scanner as a gold standard.

Planmeca CBCT Modality, Haron 3DISC intraoral scanner will be used as index tests, and Medit T710 desktop optical scanner will be used as the gold standard.

STL files from test scanning modalities will be compared using the surface matching software (Geomagic control X). The surface matching software will automatically register the two compared STL files together using the best-fit alignment tool and will generate the 3D compare for the surface comparison between them.

Study Type

Observational

Enrollment (Anticipated)

17

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Dental Plaster Casts

Description

Inclusion Criteria:

  • Adult dental casts with complete dentition and/or partially edentulous regions.
  • Maxillary and mandible casts are both included.
  • Intact casts without voids, cracks, or visible porosities

Exclusion Criteria:

  • Casts of pediatric patients.
  • Completely edentulous casts.
  • Casts with hypodontia, supernumerary teeth or fractured teeth.
  • Casts with retainers, metallic appliances, or partial dentures.
  • Casts with voids, fractures, cracks or visible porosities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CBCT
Casts STLs generated from CBCT planmeca Pro Max
Diagnostic test: Geomagic Control X
3D Surface matching and compare
Intraoral Scanner
Casts STLs generated from intraoral scanner Haron from 3DISC
Diagnostic test: Geomagic Control X
3D Surface matching and compare
Desktop Optical Scanner
Casts STLs generated from desktop optical scanner Medit T710
Diagnostic test: Geomagic Control X
3D Surface matching and compare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trueness
Time Frame: 1 year
Trueness of the CBCT and intraoral scanner to generate digital model compared to desktop optical scanner
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Precision
Time Frame: 1 year
Precision of the CBCT and intraoral scanner to generate digital models
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ORAD3-3-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information identifier: ORAD3-3-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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