Nasal DefectNCT06315621
Deviation Parameters of Intraorfal Scanning in Capturing Different Intraoral Defects
A study testing Scanning using intraoral scanner with markers, Scanning using intraoral scanner without markers and Physical Impression in people with Nasal Defect, run by Cairo University at 1 site in Egypt.
Trial summary
For all participants, a conventional facial impression will be done using silicone material then poured and scanned using a desktop scanner which represented the control group (Group 1). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nasal Defect
- What is being tested?
- Scanning using intraoral scanner with markers, Scanning using intraoral scanner without markers and Physical Impression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 20 Feb 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- isolated nasal defects either, total or subtotal.
- congenitally missing external nose with healthy and intact remaining facial structures.
Who cannot join
- Any debilitating medical condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deviation Parameters of Intraoral Scanning with and Without Artificial Markers Versus Conventional Impression of Total, Partial and Congenital Nasal Defects: a Pilot Non-Randomized Clinical Trial
For all participants, a conventional facial impression will be done using silicone material then poured and scanned using a desktop scanner which represented the control group (Group 1).
Group 2, involves nasal defects which will be optically scanned using IOS(medit 700 wireless) without facial markers Group 3 involves nasal defects which will be optically scanned using IOS(medit 700 wireless) with facial markers.
STL files of the facial scans and scanned cast obtained from the impression will be exported and saved to be used later for outcome assessment.
- Conditions
- Nasal Defect
- Being tested
- Scanning using intraoral scanner with markers, Scanning using intraoral scanner without markers, Physical Impression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scanning using intraoral scanner with markersDevice
Scanning different types of nasal defects using intraoral scanner with skin markers.
Scanning using intraoral scanner without markersDevice
Scanning different types of nasal defects using intraoral scanner without skin markers.
Physical ImpressionDevice
Recording different types of nasal defects using physical impressions
| Study group | Role | What they receive |
|---|---|---|
| Physical impression | Active comparator | Not described Receives: Device: Physical Impression |
| Scanning using intraoral scanner without markers | Experimental | Not described Receives: Device: Scanning using intraoral scanner without markers |
| Scanning using Intraoral scanner with markers | Experimental | Not described Receives: Device: Scanning using intraoral scanner with markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dimensional accuracy of intraoral scanners
measuring dimensional accuracy of diffrent scanning techniques using intraoral scanners
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Feb 2024
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal DefectStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Elmougi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315621
- Sponsor's protocol ID
- 36124
- Status last verified
- Sep 2024
- First submitted
- 5 Mar 2024
- Last updated
- 5 Sep 2024
- 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 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deviation Parameters of Intraoral Scanning with and Without Artificial Markers Versus Conventional Impression of Total, Partial and Congenital Nasal Defects: a Pilot Non-Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06315621
- Acronym / sponsor ID
- 36124
- Conditions
- Nasal Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 18 Mar 2024 (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.
For all participants, a conventional facial impression will be done using silicone material then poured and scanned using a desktop scanner which represented the control group (Group 1).
Group 2, involves nasal defects which will be optically scanned using IOS(medit 700 wireless) without facial markers Group 3 involves nasal defects which will be optically scanned using IOS(medit 700 wireless) with facial markers.
STL files of the facial scans and scanned cast obtained from the impression will be exported and saved to be used later for outcome assessment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical impression | Active comparator | Device: Physical Impression |
| Scanning using intraoral scanner without markers | Experimental | Device: Scanning using intraoral scanner without markers |
| Scanning using Intraoral scanner with markers | Experimental | Device: Scanning using intraoral scanner with markers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- isolated nasal defects either, total or subtotal.
- congenitally missing external nose with healthy and intact remaining facial structures.
Key exclusion criteria (1 listed)
- Any debilitating medical condition.
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 |
|---|---|---|
| Scanning using intraoral scanner with markersScanning different types of nasal defects using intraoral scanner with skin markers. | Device | Scanning using Intraoral scanner with markers |
| Scanning using intraoral scanner without markersScanning different types of nasal defects using intraoral scanner without skin markers. | Device | Scanning using intraoral scanner without markers |
| Physical ImpressionRecording different types of nasal defects using physical impressions | Device | Physical impression |
Primary outcome
Dimensional accuracy of intraoral scanners
Time frame: Day 0
measuring dimensional accuracy of diffrent scanning techniques using intraoral scanners
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scanning using intraoral scanner with markers, Scanning using intraoral scanner without markers and Physical Impression in people with Nasal Defect, 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 2 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: finished, as of the sponsor's last update on 5 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dimensional accuracy of intraoral scanners (time frame: Day 0). 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 5 Sep 2024.