Accuracy of CBCT Imaging and Intraoral Scanner in Dental... | NCT05817552

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

NCT05817552

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Apr 19, 2023Actual

Enrollment

17Estimated

Phase

Not provided

Conditions

Dental Cast Digitization

Interventions

Geomagic Control X

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Estimated

Primary Completion Date

Sep 1, 2023Estimated

Completion Date

May 1, 2024Estimated

First Submitted Date

Apr 5, 2023

First Submission Date that Met QC Criteria

Apr 5, 2023

First Posted Date

Apr 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2023

Last Update Posted Date

Apr 19, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
CBCT	Casts STLs generated from CBCT planmeca Pro Max	Diagnostic Test: Geomagic Control X
Intraoral Scanner	Casts STLs generated from intraoral scanner Haron from 3DISC	Diagnostic Test: Geomagic Control X
Desktop Optical Scanner	Casts STLs generated from desktop optical scanner Medit T710	Diagnostic Test: Geomagic Control X

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Geomagic Control X	Diagnostic Test	3D Surface matching and compare	CBCT Desktop Optical Scanner Intraoral Scanner

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Dental Plaster Casts

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided