Ear Deformity ExternalNCT05708339
Adaptation of Conventional Versus Virtually Fabricated Ear Prosthesis in Patients With Auricular Defects
A study testing virtually fabricated ear prosthesis and conventionally fabricated ear prosthesis in people with Ear Deformity External, run by Fatima Elmougi at 1 site in Egypt.
Trial summary
: patients were recruited for auricular prosthetic reconstruction. Preoperative data was collected including personal and medical history, plain photographs and CT scans. Pre-operative prosthetic and implant planning were carried out. Three endosseous implants were placed in a two-stage surgical technique. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ear Deformity External
- What is being tested?
- virtually fabricated ear prosthesis and conventionally fabricated ear prosthesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2019to 15 Aug 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with missing or severely deformed ears.
- Patients with failed autogenous reconstruction.
- Compliant and cooperative patients.
- Patients committed to maintain the prosthesis.
- Patients willing to attend the follow up appointments.
Who cannot join
- Patients undergoing radiotherapy or chemotherapy treatment.
- Patients taking corticosteroids or bisphosphonates.
- Patients with contraindications for CT scanning.
- Patients with any debilitating medical condition.
- Patients with any type of psychosomatic disorder.
- Patients allergic to any of the materials used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation of Conventional Versus Virtually Fabricated Ear Prosthesis in Patients With Auricular Defects: a Randomized Controlled Trial.
: patients were recruited for auricular prosthetic reconstruction. Preoperative data was collected including personal and medical history, plain photographs and CT scans. Pre-operative prosthetic and implant planning were carried out. Three endosseous implants were placed in a two-stage surgical technique. Patients were assigned into two groups with allocation ratio 1:1. In control group, Implant level impression was recorded, and a stone model of the defect was cast. waxing up of the ear was done on the stone cast followed by flasking, wax elimination, packing of heat cured acrylic resin and curing. In intervention group, CT scanning was done to the full head and optical scanning was done to the defect site with scan bodies screwed to the implants. Using Exocad software a model of the defect site with implant analogues and ear model with abutment extensions were planned and printed using SLA printing technology. A placement jig was done for ear models of both groups and adaptation was measured on the patient using silicon replica technique. The silicone replica was sectioned and the gap, represented in light consistency polyvinyl siloxane impression material was measured using digital microscope.
- Conditions
- Ear Deformity External
- Being tested
- virtually fabricated ear prosthesis, conventionally fabricated ear prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtually fabricated ear prosthesisOther
virtually designed ear prosthesis
conventionally fabricated ear prosthesisOther
conventionally fabricated ear prosthesis
| Study group | Role | What they receive |
|---|---|---|
| conventionally fabricated ear prosthesis | Active comparator | Not described Receives: Other: conventionally fabricated ear prosthesis |
| virtually fabricated ear prosthesis | Experimental | Not described Receives: Other: virtually fabricated ear prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthesis adaptation using Silicon replica measuring technique.
measuring gap between prosthesis and defect
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start20 Dec 2019
- Primary completion12 May 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear Deformity ExternalStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Elmougi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatima Elmougi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708339
- Sponsor's protocol ID
- 19115
- Status last verified
- Jan 2023
- First submitted
- 29 Dec 2022
- Last updated
- 1 Feb 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 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Conventional Versus Virtually Fabricated Ear Prosthesis in Patients With Auricular Defects: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05708339
- Acronym / sponsor ID
- 19115
- Conditions
- Ear Deformity External
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fatima ElmougiUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 1 Feb 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.
: patients were recruited for auricular prosthetic reconstruction. Preoperative data was collected including personal and medical history, plain photographs and CT scans. Pre-operative prosthetic and implant planning were carried out. Three endosseous implants were placed in a two-stage surgical technique. Patients were assigned into two groups with allocation ratio 1:1. In control group, Implant level impression was recorded, and a stone model of the defect was cast. waxing up of the ear was done on the stone cast followed by flasking, wax elimination, packing of heat cured acrylic resin and curing. In intervention group, CT scanning was done to the full head and optical scanning was done to the defect site with scan bodies screwed to the implants. Using Exocad software a model of the defect site with implant analogues and ear model with abutment extensions were planned and printed using SLA printing technology. A placement jig was done for ear models of both groups and adaptation was measured on the patient using silicon replica technique. The silicone replica was sectioned and the gap, represented in light consistency polyvinyl siloxane impression material was measured using digital microscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventionally fabricated ear prosthesis | Active comparator | Other: conventionally fabricated ear prosthesis |
| virtually fabricated ear prosthesis | Experimental | Other: virtually fabricated ear prosthesis |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with missing or severely deformed ears.
- Patients with failed autogenous reconstruction.
- Compliant and cooperative patients.
- Patients committed to maintain the prosthesis.
- Patients willing to attend the follow up appointments.
Key exclusion criteria (6 listed)
- Patients undergoing radiotherapy or chemotherapy treatment.
- Patients taking corticosteroids or bisphosphonates.
- Patients with contraindications for CT scanning.
- Patients with any debilitating medical condition.
- Patients with any type of psychosomatic disorder.
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 |
|---|---|---|
| virtually fabricated ear prosthesisvirtually designed ear prosthesis | Other | virtually fabricated ear prosthesis |
| conventionally fabricated ear prosthesisconventionally fabricated ear prosthesis | Other | conventionally fabricated ear prosthesis |
Primary outcome
Prosthesis adaptation using Silicon replica measuring technique.
Time frame: Day 1
measuring gap between prosthesis and defect
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 1 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Ear Deformity External
Recruiting
Evaluation of the Auryzon™ EAR 2.0 System in Ear Reconstruction
Microtia, Congenital, Microtia
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 virtually fabricated ear prosthesis and conventionally fabricated ear prosthesis in people with Ear Deformity External, run by Fatima Elmougi 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 5 inclusion and 6 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 1 Feb 2023. 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?
Prosthesis adaptation using Silicon replica measuring technique. (time frame: Day 1). 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 1 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.