CClinicalTrials.gg
Status unknownNCT03577210Updated Jul 5, 2018

The Degree of Accuracy of Patient-specific PEEK Implant to Restore Chin Deficiency

An interventional study of augmentation genioplasty in Chin Microgenia, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-05.

Sponsored by Cairo University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chin Microgenia

Keywords

  • chin deficiency
  • chin asymmetry
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult male or female patients.
  • Patients with retruded chin or with chin asymmetry.
  • Patients with good oral hygiene.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    computer-guided augmentation genioplasty

    patient-specific PEEK implant

    Procedure: augmentation genioplasty

Interventions

  • Procedureaugmentation genioplasty

    augmentation genioplasty with patient-specific PEEK implant

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: 6 months postoperative

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 26032759 ↗
  • Bertossi 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 26130400 ↗
  • Hsu 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03577210
Lead sponsor
Cairo University
Responsible party
Salma Hassan Abd el-Aty (Assistant lecturer, Cairo University) — Principal investigator
First posted
Jul 5, 2018
Start date
Sep 2018 (estimated)
Primary completion
Sep 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Jul 5, 2018

Study contacts

salma h Abd el-Aty, MSc
Contact
salmadent@gmail.com
0201113999772
salma h Abd el-Aty, MSc
Contact
s7_86@hotmail.com
0201005113060
Ghada abd el-monim, phd
study director · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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