Facial DefectsNCT06864091
Different Manufacturing Techniques of Facial Prostheses
A study testing Rapid Manufacturing, Direct Mould Making and Indirect Mould Making in people with Facial Defects, run by Cairo University at 1 site in Egypt.
Trial summary
All participants will undergo 3-dimentional facial scan and the defect site will be scanned using intraoral scanner. the data will be extracted in Standard tessellation Language (STL) and used in virtual prosthesis reconstruction. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Facial Defects
- What is being tested?
- Rapid Manufacturing, Direct Mould Making and Indirect Mould Making
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with cartilaginous facial defects, i.e: auricular and nasal defects.
- Patients between 20-60 years old.
- Post traumatic patients with facial defects.
- Patients with congenital facial defects.
- Patients with failed facial surgical construction.
- Compliant and cooperative patients.
Who cannot join
- 1 - Patients having risk of tumor recurrence in the defect area. 2- Patients undergoing radiotherapy or chemotherapy treatment. 3- Patients with any debilitating disease. 4- Patients with any type of psychosomatic disorder. 5- Patients with allergy to any of the materials used.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Fatma Elmougi, 01009242378, fatima.elmougi@gmail.com
About this study
Official title: Esthetic Evaluation of Facial Prostheses Fabricated Using Direct and Indirect Additive Manufacturing Techniques: A Pilot Randomized Crossover Clinical Trial
All participants will undergo 3-dimentional facial scan and the defect site will be scanned using intraoral scanner. the data will be extracted in Standard tessellation Language (STL) and used in virtual prosthesis reconstruction.
- (Group 1) involves direct printing of the final prosthesis using biocompatible rubber-like printable soft resin.
- Group 2, involves direct manufacturing of the negative mold, it will be virtually designed based on an inverted STL file of prosthesis prototype/ pattern.
- Group 3, involves fabrication of the negative mold indirectly by printing the prosthesis prototype from resin and then duplicating it into wax and a conventional stone mold will be fabricated.
- The negative molds of both groups 2\&3 will be used in packing medical grade silicone (to cast the final prosthesis.
- All final prostheses will be colored and characterized to match the surrounding anatomy.
- Esthetic outcomes will be assessed using VAS scale by answering operator and patient related questionnaires. The patient related questionnaire will be translated to the patients and responses will be recorded. For each patient, a score will be given from 1-5.
- Prosthesis accuracy will be assessed using Medit software, comparing the scan of the final prosthesis to the STL of the prosthesis design and the root mean square (RMS) will be recorded.
- Conditions
- Facial Defects
- Being tested
- Rapid Manufacturing, Direct Mould Making, Indirect Mould Making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid ManufacturingOther
The first intervention (I1) involves direct printing of the final prosthesis (rapid manufacturing, RM). The final prosthesis will be printed using a biocompatible rubber-like printable soft resin (Biomed Flex 80A resin, Formlabs, USA), and then will be colored and characterized to match the surrounding anatomy.
Direct Mould MakingOther
In the second intervention (I2), the negative mold will be achieved directly, will be virtually designed based on an inverted STL file of prosthesis prototype/ pattern (direct mold making, DMM).
Indirect Mould MakingOther
the negative mold will be fabricated indirectly by printing the prosthesis prototype from resin for subsequent mold fabrication (indirect mold making, IMM). The printed prototype will be tried on the patient and adjusted in terms of shape, size and marginal fit.
After the try-in stage the prototype will be duplicated into wax by using silicone rubber molding and a conventional stone mold will be fabricated.
| Study group | Role | What they receive |
|---|---|---|
| Direct Mould Making | Experimental | Not described Receives: Other: Direct Mould Making |
| Indirect Mould Making | Experimental | Not described Receives: Other: Indirect Mould Making |
| Rapid Manufacturing | Experimental | Not described Receives: Other: Rapid Manufacturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esthetic Outcomes
Esthetic outcomes will be assessed using VAS scale by answering operator and patient related questionnaires. The patient related questionnaire will be translated to the patients and responses will be recorded. For each patient, a score will be given from 1-5.
Measured: 3 months
Secondary outcomes (1)
Prosthesis Accuracy
Prosthesis accuracy will be assessed using Medit software, comparing the scan of the final prosthesis to the STL of the prosthesis design and the root mean square (RMS) will be recorded.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Oct 2024
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial DefectsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (estimated)
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
- NCT06864091
- Sponsor's protocol ID
- 1024
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 7 Mar 2025
- 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 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Evaluation of Facial Prostheses Fabricated Using Direct and Indirect Additive Manufacturing Techniques: A Pilot Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT06864091
- Acronym / sponsor ID
- 1024
- Conditions
- Facial Defects
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 7 Mar 2025 (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.
All participants will undergo 3-dimentional facial scan and the defect site will be scanned using intraoral scanner. the data will be extracted in Standard tessellation Language (STL) and used in virtual prosthesis reconstruction.
- (Group 1) involves direct printing of the final prosthesis using biocompatible rubber-like printable soft resin.
- Group 2, involves direct manufacturing of the negative mold, it will be virtually designed based on an inverted STL file of prosthesis prototype/ pattern.
- Group 3, involves fabrication of the negative mold indirectly by printing the prosthesis prototype from resin and then duplicating it into wax and a conventional stone mold will be fabricated.
- The negative molds of both groups 2\&3 will be used in packing medical grade silicone (to cast the final prosthesis.
- All final prostheses will be colored and characterized to match the surrounding anatomy.
- Esthetic outcomes will be assessed using VAS scale by answering operator and patient related questionnaires. The patient related questionnaire will be translated to the patients and responses will be recorded. For each patient, a score will be given from 1-5.
- Prosthesis accuracy will be assessed using Medit software, comparing the scan of the final prosthesis to the STL of the prosthesis design and the root mean square (RMS) will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Direct Mould Making | Experimental | Other: Direct Mould Making |
| Indirect Mould Making | Experimental | Other: Indirect Mould Making |
| Rapid Manufacturing | Experimental | Other: Rapid Manufacturing |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with cartilaginous facial defects, i.e: auricular and nasal defects.
- Patients between 20-60 years old.
- Post traumatic patients with facial defects.
- Patients with congenital facial defects.
- Patients with failed facial surgical construction.
Key exclusion criteria (1 listed)
- 1 - Patients having risk of tumor recurrence in the defect area. 2- Patients undergoing radiotherapy or chemotherapy treatment. 3- Patients with any debilitating disease. 4- Patients with any type of psychosomatic disorder. 5- Patients with allergy to any of the materials used.
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 |
|---|---|---|
| Rapid ManufacturingThe first intervention (I1) involves direct printing of the final prosthesis (rapid manufacturing, RM). The final prosthesis will be printed using a biocompatible rubber-like printable soft resin (Biomed Flex 80A resin, Formlabs, USA), and then will be colored and characterized to match the surrounding anatomy. | Other | Rapid Manufacturing |
| Direct Mould MakingIn the second intervention (I2), the negative mold will be achieved directly, will be virtually designed based on an inverted STL file of prosthesis prototype/ pattern (direct mold making, DMM). | Other | Direct Mould Making |
| Indirect Mould Makingthe negative mold will be fabricated indirectly by printing the prosthesis prototype from resin for subsequent mold fabrication (indirect mold making, IMM). The printed prototype will be tried on the patient and adjusted in terms of shape, size and marginal fit. After the try-in stage the prototype will be duplicated into wax by using silicone rubber molding and a conventional stone mold will be fabricated. | Other | Indirect Mould Making |
Primary outcome
Esthetic Outcomes
Time frame: 3 months
Esthetic outcomes will be assessed using VAS scale by answering operator and patient related questionnaires. The patient related questionnaire will be translated to the patients and responses will be recorded. For each patient, a score will be given from 1-5.
1 secondary outcome
Prosthesis Accuracy
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Manufacturing, Direct Mould Making and Indirect Mould Making in people with Facial Defects, 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 6 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: looking for participants now, as of the sponsor's last update on 7 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma M Elmougi (+201009242378, fatima.elmougi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esthetic Outcomes (time frame: 3 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 7 Mar 2025.