OrthodonticsNCT03103802
Evaluation of the Accuracy of Digital Models Obtained Using Intraoral and Extraoral Scanners
A study testing intra-oral digital scanner and extra-oral digital scanner in people with Orthodontics, run by Cairo University at 1 site in Egypt.
Trial summary
This study is to compare the diagnostic accuracy of digital models obtained via 10 digitization techniques to the reference standard of orthodontic plaster model through dental measurements Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontics
- What is being tested?
- intra-oral digital scanner and extra-oral digital scanner
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2017to 27 Feb 2018
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult patients seeking orthodontic treatment permanent dentition
Who cannot join
- deciduous or mixed dentition cleft lip and palate patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry- Cairo University
Cairo Governorate, Cairo Governorate, 12613
Mohamed A Labib, DDS
About this study
Official title: Evaluation of the Accuracy of Digital Models Obtained Using Intraoral and Extraoral Scanners Versus Gold Standard Plaster Model (Diagnostic Accuracy Study)
This study is to compare the diagnostic accuracy of digital models obtained via 10 digitization techniques to the reference standard of orthodontic plaster model through dental measurements
- Conditions
- Orthodontics
- Being tested
- intra-oral digital scanner and extra-oral digital scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-oral digital scanner and extra-oral digital scannerDevice
intra-oral and extra-oral digital scanners used to obtain digital models
| Study group | Role | What they receive |
|---|---|---|
| Intra-oral scanning | Experimental | Not described Receives: Device: intra-oral digital scanner and extra-oral digital scanner |
| extra-oral scanning of the plaster model obtained via alginate | Experimental | Not described Receives: Device: intra-oral digital scanner and extra-oral digital scanner |
| extra-oral scanning of plaster model obtained via rubber base | Experimental | Not described Receives: Device: intra-oral digital scanner and extra-oral digital scanner |
| extra-oral scanning of the rubber base impression | Experimental | Not described Receives: Device: intra-oral digital scanner and extra-oral digital scanner |
| extra-oral scanning of the alginate impression | Experimental | Not described Receives: Device: intra-oral digital scanner and extra-oral digital scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy
evaluation of the accuracy of digital models obtained using scanners
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start30 Apr 2017 (estimated)
- Primary completion30 Oct 2017 (estimated)
- Study completion27 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moahmed Amr Labib, Cairo University
- Investigators
- Khaled Hazem, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103802
- Sponsor's protocol ID
- CEBD-CU-2017-03-24
- Status last verified
- Apr 2017
- First submitted
- 1 Apr 2017
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Digital Models Obtained Using Intraoral and Extraoral Scanners Versus Gold Standard Plaster Model (Diagnostic Accuracy Study)
- ClinicalTrials.gov ID
- NCT03103802
- Acronym / sponsor ID
- CEBD-CU-2017-03-24
- Conditions
- Orthodontics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2017 (estimated)
- Primary completion
- 30 Oct 2017 (estimated)
- Study completion
- 27 Feb 2018 (estimated)
- First posted
- 6 Apr 2017 (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.
This study is to compare the diagnostic accuracy of digital models obtained via 10 digitization techniques to the reference standard of orthodontic plaster model through dental measurements
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Intra-oral scanning | Experimental | Device: intra-oral digital scanner and extra-oral digital scanner |
| extra-oral scanning of the plaster model obtained via alginate | Experimental | Device: intra-oral digital scanner and extra-oral digital scanner |
| extra-oral scanning of plaster model obtained via rubber base | Experimental | Device: intra-oral digital scanner and extra-oral digital scanner |
| extra-oral scanning of the rubber base impression | Experimental | Device: intra-oral digital scanner and extra-oral digital scanner |
| extra-oral scanning of the alginate impression | Experimental | Device: intra-oral digital scanner and extra-oral digital scanner |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adult patients seeking orthodontic treatment permanent dentition
Key exclusion criteria (1 listed)
- deciduous or mixed dentition cleft lip and palate patients
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 |
|---|---|---|
| intra-oral digital scanner and extra-oral digital scannerintra-oral and extra-oral digital scanners used to obtain digital models | Device | Intra-oral scanning, extra-oral scanning of plaster model obtained via rubber base, extra-oral scanning of the alginate impression, extra-oral scanning of the plaster model obtained via alginate, extra-oral scanning of the rubber base impression |
Primary outcome
diagnostic accuracy
Time frame: 6 months
evaluation of the accuracy of digital models obtained using scanners
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Individual participant dataSharing planned: Yes
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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.
Khaled Hazem, PHD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-oral digital scanner and extra-oral digital scanner in people with Orthodontics, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Mohamed A Labib, DDS (00201222144339, mohamedlabib90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy (time frame: 6 months). 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 11 Apr 2017.