Accuracy of Patient Specific 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgeries. A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 26
- Primary Endpoint
- Accuracy of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty
Study Overview
Brief Summary
To assess accuracy of patient specific 3D printed titanium plates versus 3D milled titanium plates in genioplasty orthognathic surgery
Detailed Description
the first treatment include treating patients with 3D printed titanium plates while the second treatment include treating patients with 3D milled titanium plates in genioplasty orthognathic surgery and assess the accuracy between the two treatments
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
- •Patients with no signs or symptoms of active TMDs.
- •Highly motivated patients.
Exclusion Criteria
- •Patients who refused to be included in the research.
- •Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
- •Patients with intra-bony lesions or infections that may retard the osteotomy healing.
- •Patients with systemic condition contraindicating with the surgical procedure as uncontrolled diabetes
Outcomes
Primary Outcomes
Accuracy of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty
Time Frame: immediately postoperative
Accuracy of manufacturing of the patient specific customized 3D printed titanium plates in the study group versus milled titanium plates in the control group in genioplasty measure The skull base in the virtual surgical plan was superimposed using point-based matching ICP registration using anatomical reference points, followed by manual surface-based registration to surface best fit with the skull base in the actual post-operative CBCT scans. the measurement tool is CBCT scans superimposition in mm
Secondary Outcomes
- stability of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty(6 months postoperative)
Investigators
Mina ElHadidi Sobhi Ramzi Michael
Principal Investigator
Cairo University