Dental Cast DigitizationNCT05817552
Accuracy of CBCT Imaging and Intraoral Scanner in Dental Plaster Casts Digitization: A Validity and Reliability Study
An observational study of Dental Cast Digitization, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Cast Digitization
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Dental Plaster Casts
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Dental Cast Digitization
- Being tested
- Geomagic Control X
- Keywords
- CBCT - Intraoral scanner - Cast digitization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geomagic Control XDiagnostic test
3D Surface matching and compare
| Study group | Role | What they receive |
|---|---|---|
| CBCT | Casts STLs generated from CBCT planmeca Pro Max Receives: Diagnostic Test: Geomagic Control X | |
| Intraoral Scanner | Casts STLs generated from intraoral scanner Haron from 3DISC Receives: Diagnostic Test: Geomagic Control X | |
| Desktop Optical Scanner | Casts STLs generated from desktop optical scanner Medit T710 Receives: Diagnostic Test: Geomagic Control X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trueness
Trueness of the CBCT and intraoral scanner to generate digital model compared to desktop optical scanner
Measured: 1 year
Secondary outcomes (1)
Precision
Precision of the CBCT and intraoral scanner to generate digital models
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Cast DigitizationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Sayed Badry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817552
- Sponsor's protocol ID
- ORAD3-3-1
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of CBCT Imaging and Intraoral Scanner in Dental Plaster Casts Digitization: A Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT05817552
- Acronym / sponsor ID
- ORAD3-3-1
- Conditions
- Dental Cast Digitization
- Keywords
- CBCT - Intraoral scanner - Cast digitization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBCT | – | Diagnostic Test: Geomagic Control XCasts STLs generated from CBCT planmeca Pro Max |
| Intraoral Scanner | – | Diagnostic Test: Geomagic Control XCasts STLs generated from intraoral scanner Haron from 3DISC |
| Desktop Optical Scanner | – | Diagnostic Test: Geomagic Control XCasts STLs generated from desktop optical scanner Medit T710 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Dental Plaster Casts
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geomagic Control X3D Surface matching and compare | Diagnostic test | CBCT, Desktop Optical Scanner, Intraoral Scanner |
Primary outcome
Trueness
Time frame: 1 year
Trueness of the CBCT and intraoral scanner to generate digital model compared to desktop optical scanner
1 secondary outcome
Precision
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Cast Digitization, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trueness (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.