The Degree of Accuracy of Patient-specific PEEK Implant to Restore Chin Deficiency
1 other identifier
interventional
20
1 country
1
Brief Summary
computer guided patient-specific PEEK implant will be used to augment patients with chin deficiency or chin asymmetry.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2018
CompletedFirst Posted
Study publicly available on registry
July 5, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedJuly 5, 2018
July 1, 2018
1 year
May 16, 2018
July 3, 2018
Conditions
Keywords
Outcome Measures
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
two weeks postoperative
Secondary Outcomes (1)
patient satisfaction with postoperative chin appearance and pain: Face-Q questionnaire
6 months postoperative
Study Arms (1)
computer-guided augmentation genioplasty
OTHERpatient-specific PEEK implant
Interventions
augmentation genioplasty with patient-specific PEEK implant
Eligibility Criteria
You may qualify if:
- Adult male or female patients.
- Patients with retruded chin or with chin asymmetry.
- Patients with good oral hygiene.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Salma Hassan
Cairo, 21111, Egypt
Related Publications (3)
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.
PMID: 26032759BACKGROUNDBertossi 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.
PMID: 26130400BACKGROUNDHsu 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.
PMID: 22695016BACKGROUND
Study Officials
- STUDY DIRECTOR
Ghada abd el-monim, phd
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
May 16, 2018
First Posted
July 5, 2018
Study Start
September 1, 2018
Primary Completion
September 1, 2019
Study Completion
October 1, 2019
Last Updated
July 5, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share