Assessment of Accuracy and Aesthetics Following Automated Mandibular Defect Reconstruction Using AI
1 other identifier
interventional
4
0 countries
N/A
Brief Summary
The Aim of the study is to evaluate Accuracy of automated mandibular defect reconstruction using Artificial intelligence and assessing impact on aesthetic and occlusion outcomes using patient-specific reconstruction plates.
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 May 2025
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
April 10, 2025
CompletedFirst Posted
Study publicly available on registry
April 25, 2025
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedApril 25, 2025
April 1, 2025
11 months
April 10, 2025
April 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Accuracy Of the virtually Generated 3D model using AI
The measuring device is the AI model using the Percentage as a unit
baseline
Accuracy of AI generated model clinically
The measuring device is by Superimposition of both virtual 3-d generated model and real patient CT post operative using software ( blender ) . ( Structural Similarity Index) (SSIM)
baseline
Secondary Outcomes (2)
Aethetic outcome
baseline
Occlusion
baseline
Study Arms (1)
Patient specific reconstruction plates
EXPERIMENTALPatients with benign lesions indicated for resection and resulting in mandibular continuity defects treated with patient specific reconstruction plates.
Interventions
Use of patient specific reconstruction plates on the 3-D virtually-generated defect using Artificial Intelligence.
Eligibility Criteria
You may qualify if:
- Patients with mandibular tumors, cysts or any benign disease resulting in mandibular continuity defect.
- Age group: from 18 - 55 years old.
- No sex predilection.
- CTs or CBCTs of only healthy mandibles from an online database and real data.
You may not qualify if:
- Patients with mandibular malignant lesions.
- Children age group from 2-17.
- CTs Of maxilla.
- Elderly patients to be excluded due to the normal physiologic bony change.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (2)
Liang Y, Huan J, Li JD, Jiang C, Fang C, Liu Y. Use of artificial intelligence to recover mandibular morphology after disease. Sci Rep. 2020 Oct 2;10(1):16431. doi: 10.1038/s41598-020-73394-5.
PMID: 33009429BACKGROUNDvan Baar GJC, Forouzanfar T, Liberton NPTJ, Winters HAH, Leusink FKJ. Accuracy of computer-assisted surgery in mandibular reconstruction: A systematic review. Oral Oncol. 2018 Sep;84:52-60. doi: 10.1016/j.oraloncology.2018.07.004. Epub 2018 Jul 20.
PMID: 30115476BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Moustafa, MSc.
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer, oral and maxillofacial surgery department, Ahram Canadian University, PHD Student at Cairo university.
Study Record Dates
First Submitted
April 10, 2025
First Posted
April 25, 2025
Study Start
May 1, 2025
Primary Completion
April 1, 2026
Study Completion
May 1, 2026
Last Updated
April 25, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share