Patient Loss His Ear and Need Auricular ProsthesisNCT04893902
Digital VS. Conventional Ear Impression
A study testing medit intra oral scanner in people with Patient Loss His Ear and Need Auricular Prosthesis, run by Mohamed Mahmoud Dohiem at 1 site in Egypt.
Trial summary
What is known: Ear impressions are made in conventional manner by impression materials which may affect the accuracy of the obtained data and consume time and effort . What this study adds: Predesigned ear markers facilitate ear scanning using an intraoral scanner that decreases the probability of in-accuracies using… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient Loss His Ear and Need Auricular Prosthesis
- What is being tested?
- medit intra oral scanner
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2021to 17 May 2021
- 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
- any normal patient
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohamed Mahmoud dohiem
Cairo, 11742
Mohamed M dohiem, lecturer, 00201002411965, mdohiem@zu.edu.eg
About this study
Official title: An Innovative Approach for Auricular Rehabilitation Using Two Types Digital Impression Versus Conventional Techniques:
What is known:
Ear impressions are made in conventional manner by impression materials which may affect the accuracy of the obtained data and consume time and effort .
What this study adds:
Predesigned ear markers facilitate ear scanning using an intraoral scanner that decreases the probability of in-accuracies using the conventional manner with less time and effort
Read the detailed description
Prosthodontic maxillofacial rehabilitation of acquired or congenital ear defects is considered a challenging procedure. This clinical trial introduces a novel approach for digital scanning of the unaffected contralateral ear using an intraoral scanner in comparison to the conventional impression techniques. CAD/CAM is a very promising design and fabrication of an auricular prosthesis for patients with unilateral ear defects.
Purpose: This study aims to compare digital impression technique using an intra-oral digital scanner IOSfor the unaffected ear with markers /without markers versus traditional techniques with hydro colloidal impression materials.
- Being tested
- medit intra oral scanner
- Keywords
- Ear impression -Ear scanning-intraoral scanner-scannin marker-ear prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medit intra oral scannerDevice
ear scanning with intra oral scanner
| Study group | Role | What they receive |
|---|---|---|
| conventional ear impression | Active comparator | Not described Receives: Device: medit intra oral scanner |
| digital auricular impression without marker using intra oral scanner | Experimental | Not described Receives: Device: medit intra oral scanner |
| digital auricular impression with marker using intra oral scanner | Experimental | Not described Receives: Device: medit intra oral scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
total deviation between Conventional auricular impression and two types of digital impression
Measured: 1 day
Secondary outcomes (1)
total deviation between two types of digital impression
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start15 May 2021 (estimated)
- Primary completion16 May 2021 (estimated)
- Study completion17 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient Loss His Ear and Need Auricular ProsthesisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- control clinical rial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Mahmoud Dohiem
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Mohamed Mahmoud Dohiem, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893902
- Sponsor's protocol ID
- dohiem md
- Status last verified
- May 2021
- First submitted
- 14 May 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dohiem MM, Emam NS, Abdallah MF, Abdelaziz MS. Accuracy of digital auricular impression using intraoral scanner versus conventional impression technique for ear rehabilitation: A controlled clinical trial. J Plast Reconstr Aesthet Surg. 2022 Nov;75(11):4254-4263. doi: 10.1016/j.bjps.2022.08.002. Epub 2022 Aug 5.
PubMed 36117136
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Approach for Auricular Rehabilitation Using Two Types Digital Impression Versus Conventional Techniques:
- ClinicalTrials.gov ID
- NCT04893902
- Acronym / sponsor ID
- dohiem md
- Keywords
- Ear impression -Ear scanning-intraoral scanner-scannin marker-ear prosthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Mohamed Mahmoud DohiemOther government
- Study start
- 15 May 2021 (estimated)
- Primary completion
- 16 May 2021 (estimated)
- Study completion
- 17 May 2021 (estimated)
- First posted
- 20 May 2021 (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.
What is known:
Ear impressions are made in conventional manner by impression materials which may affect the accuracy of the obtained data and consume time and effort .
What this study adds:
Predesigned ear markers facilitate ear scanning using an intraoral scanner that decreases the probability of in-accuracies using the conventional manner with less time and effort
Detailed description
Prosthodontic maxillofacial rehabilitation of acquired or congenital ear defects is considered a challenging procedure. This clinical trial introduces a novel approach for digital scanning of the unaffected contralateral ear using an intraoral scanner in comparison to the conventional impression techniques. CAD/CAM is a very promising design and fabrication of an auricular prosthesis for patients with unilateral ear defects.
Purpose: This study aims to compare digital impression technique using an intra-oral digital scanner IOSfor the unaffected ear with markers /without markers versus traditional techniques with hydro colloidal impression materials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- control clinical rial
| Arm | Type | Receives |
|---|---|---|
| conventional ear impression | Active comparator | Device: medit intra oral scanner |
| digital auricular impression without marker using intra oral scanner | Experimental | Device: medit intra oral scanner |
| digital auricular impression with marker using intra oral scanner | Experimental | Device: medit intra oral scanner |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- any normal patient
Key exclusion criteria (1 listed)
- no exclusion criteria
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 |
|---|---|---|
| medit intra oral scannerear scanning with intra oral scanner | Device | conventional ear impression, digital auricular impression with marker using intra oral scanner, digital auricular impression without marker using intra oral scanner |
Primary outcome
total deviation between Conventional auricular impression and two types of digital impression
Time frame: 1 day
1 secondary outcome
total deviation between two types of digital impression
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Derived from this study: PubMed 36117136Dohiem MM, Emam NS, Abdallah MF, Abdelaziz MS. Accuracy of digital auricular impression using intraoral scanner versus conventional impression technique for ear rehabilitation: A controlled clinical trial. J Plast Reconstr Aesthet Surg. 2022 Nov;75(11):4254-4263. doi: 10.1016/j.bjps.2022.08.002. Epub 2022 Aug 5.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medit intra oral scanner in people with Patient Loss His Ear and Need Auricular Prosthesis, run by Mohamed Mahmoud Dohiem 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 20 May 2021. 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 M dohiem, lecturer (01002411965, mdohiem@zu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total deviation between Conventional auricular impression and two types of digital impression (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04893902, which also lists 1 linked publication.
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 20 May 2021.