Chin MicrogeniaNCT03577210
The Degree of Accuracy of Patient-specific PEEK Implant to Restore Chin Deficiency
A study testing augmentation genioplasty in people with Chin Microgenia, run by Cairo University at 1 site in Egypt.
Trial summary
computer guided patient-specific PEEK implant will be used to augment patients with chin deficiency or chin asymmetry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chin Microgenia
- What is being tested?
- augmentation genioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2018to Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female patients.
- Patients with retruded chin or with chin asymmetry.
- Patients with good oral hygiene.
Who cannot join
- Patients that need skeletal procedure in the mandible, other than genioplasty, at the same time of surgery or was done within time period less than 6 months.
- Patients with medical condition that may compromise the healing process.
- Patients with medical condition that is contraindicated for general anaesthesia.
- Presence of pathological lesion related to chin area.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Salma Hassan
Cairo, 21111
salma hassan, MSc, 0201113999772, salmadent86@gmail.com
Ghada Abd el-Monim, Phd, 0201005113060, ghada.abdelmonim@dentistry.cu.edu.eg
About this study
Official title: The Degree of Accuracy of Patient-specific PEEK Implant to Restore Chin Deficiency. Accuracy Study
computer guided patient-specific PEEK implant will be used to augment patients with chin deficiency or chin asymmetry.
Read the detailed description
augmentation genioplasty will be done to patients with chin deficiency or asymmetry. using cone beam CT for each patient and special soft ware "MIMICS 15" , patient-specific implant design can be done. PEEK will be milled as CAD-CAM technique to finally get patient specific PEEK implant. with patient is under General anesthesia, the implant will inserted and fixed with titanium screws. closure in two layers will be done.
- Conditions
- Chin Microgenia
- Being tested
- augmentation genioplasty
- Keywords
- chin deficiency, chin asymmetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
augmentation genioplastyProcedure or surgery
augmentation genioplasty with patient-specific PEEK implant
| Study group | Role | What they receive |
|---|---|---|
| computer-guided augmentation genioplasty | Other | patient-specific PEEK implant Receives: Procedure: augmentation genioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm
degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm
Measured: two weeks postoperative
Secondary outcomes (1)
patient satisfaction with postoperative chin appearance and pain: Face-Q questionnaire
degree of patient satisfaction using Face-Q questionnaire with score from 0-100 where 0 shows least degree of satisfaction and 100 shows best degree of satisfaction.
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study startSep 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Hassan Abd el-Aty, Cairo University
- Investigators
- Ghada abd el-monim, phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577210
- Sponsor's protocol ID
- Salma Hassan
- Status last verified
- Jul 2018
- First submitted
- 16 May 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alonso-Rodriguez E, Cebrian JL, Nieto MJ, Del Castillo JL, Hernandez-Godoy J, Burgueno M. Polyetheretherketone custom-made implants for craniofacial defects: Report of 14 cases and review of the literature. J Craniomaxillofac Surg. 2015 Sep;43(7):1232-8. doi: 10.1016/j.jcms.2015.04.028. Epub 2015 May 8.
PubMed 26032759Bertossi D, Galzignato PF, Albanese M, Botti C, Botti G, Nocini PF. Chin Microgenia: A Clinical Comparative Study. Aesthetic Plast Surg. 2015 Oct;39(5):651-8. doi: 10.1007/s00266-015-0518-4. Epub 2015 Jul 1.
PubMed 26130400Hsu SS, Gateno J, Bell RB, Hirsch DL, Markiewicz MR, Teichgraeber JF, Zhou X, Xia JJ. Accuracy of a computer-aided surgical simulation protocol for orthognathic surgery: a prospective multicenter study. J Oral Maxillofac Surg. 2013 Jan;71(1):128-42. doi: 10.1016/j.joms.2012.03.027. Epub 2012 Jun 12.
PubMed 22695016
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Degree of Accuracy of Patient-specific PEEK Implant to Restore Chin Deficiency. Accuracy Study
- ClinicalTrials.gov ID
- NCT03577210
- Acronym / sponsor ID
- Salma Hassan
- Conditions
- Chin Microgenia
- Keywords
- chin deficiency, chin asymmetry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 5 Jul 2018 (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.
computer guided patient-specific PEEK implant will be used to augment patients with chin deficiency or chin asymmetry.
Detailed description
augmentation genioplasty will be done to patients with chin deficiency or asymmetry. using cone beam CT for each patient and special soft ware "MIMICS 15" , patient-specific implant design can be done. PEEK will be milled as CAD-CAM technique to finally get patient specific PEEK implant. with patient is under General anesthesia, the implant will inserted and fixed with titanium screws. closure in two layers will be done.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| computer-guided augmentation genioplasty | Other | Procedure: augmentation genioplastypatient-specific PEEK implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male or female patients.
- Patients with retruded chin or with chin asymmetry.
- Patients with good oral hygiene.
Key exclusion criteria (4 listed)
- Patients that need skeletal procedure in the mandible, other than genioplasty, at the same time of surgery or was done within time period less than 6 months.
- Patients with medical condition that may compromise the healing process.
- Patients with medical condition that is contraindicated for general anaesthesia.
- Presence of pathological lesion related to chin area.
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 |
|---|---|---|
| augmentation genioplastyaugmentation genioplasty with patient-specific PEEK implant | Procedure or surgery | computer-guided augmentation genioplasty |
Primary outcome
degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm
Time frame: two weeks postoperative
degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm
1 secondary outcome
patient satisfaction with postoperative chin appearance and pain: Face-Q questionnaire
Time frame: 6 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Background: PubMed 26032759Alonso-Rodriguez E, Cebrian JL, Nieto MJ, Del Castillo JL, Hernandez-Godoy J, Burgueno M. Polyetheretherketone custom-made implants for craniofacial defects: Report of 14 cases and review of the literature. J Craniomaxillofac Surg. 2015 Sep;43(7):1232-8. doi: 10.1016/j.jcms.2015.04.028. Epub 2015 May 8.
- Background: PubMed 26130400Bertossi D, Galzignato PF, Albanese M, Botti C, Botti G, Nocini PF. Chin Microgenia: A Clinical Comparative Study. Aesthetic Plast Surg. 2015 Oct;39(5):651-8. doi: 10.1007/s00266-015-0518-4. Epub 2015 Jul 1.
- Background: PubMed 22695016Hsu SS, Gateno J, Bell RB, Hirsch DL, Markiewicz MR, Teichgraeber JF, Zhou X, Xia JJ. Accuracy of a computer-aided surgical simulation protocol for orthognathic surgery: a prospective multicenter study. J Oral Maxillofac Surg. 2013 Jan;71(1):128-42. doi: 10.1016/j.joms.2012.03.027. Epub 2012 Jun 12.
- Individual participant dataSharing planned: No
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.
Ghada abd el-monim, phd study director
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 augmentation 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 3 inclusion and 4 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 5 Jul 2018. 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 salma h Abd el-Aty, MSc (0201113999772, salmadent@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of accuracy of patient specific peek implant in chin augmentation as virtually planned using Mimics software, measuring unit (mm) mm (time frame: two weeks postoperative). 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 NCT03577210, which also lists 3 linked publications.
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 Jul 2018.