Chin MicrogeniaNCT04817930
Patient-specific Alloplastic Chin Implant Versus Computer Guided Genioplasty: Soft Tissue Assessment After One Year Follow up
A study testing Polyetheretherketone patient specific implant and Computer guided advancement genioplasty in people with Chin Microgenia, run by Cairo University at 1 site in Egypt.
Trial summary
Two groups with retruded chin skeletal deformity. one treated with patient specific alloplastic implant and the other was treated with computer guided advancement genioplasty. soft tissue assessment was executed after one year Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chin Microgenia
- What is being tested?
- Polyetheretherketone patient specific implant and Computer guided advancement genioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jan 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients whose clinical features revealed possible correction of their facial deformity using chin surgery only
- No prior surgery involving the chin
Who cannot join
- Patients whose clinical features revealed possible correction of their facial deformity using mandibular surgeries.
- Patients with systemic diseases that carried high risk for general anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Two groups with retruded chin skeletal deformity. one treated with patient specific alloplastic implant and the other was treated with computer guided advancement genioplasty. soft tissue assessment was executed after one year
- Conditions
- Chin Microgenia
- Being tested
- Polyetheretherketone patient specific implant, Computer guided advancement genioplasty
- Keywords
- Chin microgenia, Orthognathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyetheretherketone patient specific implantDevice
a customized peek patient specific implant is place to augment the chin
Computer guided advancement genioplastyDevice
advancement genioplasty using patient specific cutting and positioning surgical stents
| Study group | Role | What they receive |
|---|---|---|
| Patient specific chin implant | Experimental | A patient specific chin peek implant was used for chin augmentation Receives: Device: Polyetheretherketone patient specific implant |
| computer guided advancement genioplasty | Experimental | Computer guided advancement genioplasty using patient specific cutting and positioning guides Receives: Device: Computer guided advancement genioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
soft tissue effect
The impact of the interventions on the soft tissue gain after one year
Measured: after one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chin MicrogeniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shawky, Cairo University
- Investigators
- Mohamed Shawky, Principal investigator, Assistant lecturer. OMFS. Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817930
- Sponsor's protocol ID
- OMFS 3-3-6
- Status last verified
- Mar 2021
- First submitted
- 21 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: intervention and effect and demographic data
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-specific Alloplastic Chin Implant Versus Computer Guided Genioplasty: Soft Tissue Assessment After One Year Follow up
- ClinicalTrials.gov ID
- NCT04817930
- Acronym / sponsor ID
- OMFS 3-3-6
- Conditions
- Chin Microgenia
- Keywords
- Chin microgenia, Orthognathic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 26 Mar 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.
Two groups with retruded chin skeletal deformity. one treated with patient specific alloplastic implant and the other was treated with computer guided advancement genioplasty. soft tissue assessment was executed after one year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient specific chin implant | Experimental | Device: Polyetheretherketone patient specific implantA patient specific chin peek implant was used for chin augmentation |
| computer guided advancement genioplasty | Experimental | Device: Computer guided advancement genioplastyComputer guided advancement genioplasty using patient specific cutting and positioning guides |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients whose clinical features revealed possible correction of their facial deformity using chin surgery only
- No prior surgery involving the chin
Key exclusion criteria (2 listed)
- Patients whose clinical features revealed possible correction of their facial deformity using mandibular surgeries.
- Patients with systemic diseases that carried high risk for general anesthesia.
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 |
|---|---|---|
| Polyetheretherketone patient specific implanta customized peek patient specific implant is place to augment the chin | Device | Patient specific chin implant |
| Computer guided advancement genioplastyadvancement genioplasty using patient specific cutting and positioning surgical stents | Device | computer guided advancement genioplasty |
Primary outcome
soft tissue effect
Time frame: after one year
The impact of the interventions on the soft tissue gain after one year
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 26 Mar 2021.
- Individual participant dataSharing planned: No. intervention and effect and demographic data
Related trials for Chin Microgenia
Recruiting
Clinical Evaluation of Patient-Specific 3D-Printed Titanium Implants for Facial Reconstruction.
Hemifacial Microsomia, Mucormycosis
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.
Mohamed Shawky principal investigator
Assistant lecturer. OMFS. 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 Polyetheretherketone patient specific implant and Computer guided advancement genioplasty in people with Chin Microgenia, 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 2 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 26 Mar 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?
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?
soft tissue effect (time frame: after one year). 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 26 Mar 2021.