Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty, Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgery, Patient Specific Genioplasty
Conditions
Keywords
accuracy of 3D printed titanium plates versus 3D milled titanium plates in genioplasty, patient specific genioplasty, patient specific 3D printed titanium plates genioplasty, patient specific 3D milled titanium plates genioplasty, genioplasty orthognathic surgery
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
Interventions
PROCEDUREgenioplasty using 3D printed patient specific titanium plates (study group)
genioplasty using 3D printed patient specific titanium plates (study group) the treatment plan includes fixing the chin with 3D printed patient specific titanium plates in genioplasty orthognathic surgery
PROCEDUREgenioplasty using 3D milled patient specific titanium plates (control group)
genioplasty using 3D milled patient specific titanium plates (control group) The treatment plan includes fixing the chin with 3D milled patient specific titanium plates in genioplasty orthognathic surgery
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
the treatment include fixing the chin in genioplasty orthognathic surgery with 3D printed patient specific titanium plates
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries. 2. Patients with no signs or symptoms of active TMDs. 3. Highly motivated patients.
Exclusion criteria
1. Patients who refused to be included in the research. 2. Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia. 3. Patients with intra-bony lesions or infections that may retard the osteotomy healing. 4. Patients with systemic condition contraindicating with the surgical procedure as uncontrolled diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty | 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
| Measure | Time frame | Description |
|---|---|---|
| stability of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty | 6 months postoperative | stability 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 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 6 months post-operative CBCT scans. the measurement tool is CBCT scans superimposition in mm |
Other
| Measure | Time frame | Description |
|---|---|---|
| Soft tissue dehiscence | 2 months postoperatively | measurement of the amount of dehiscence and exposure of the plate and bone vertically and horizontally by periodontal probe the measurement tool is periodontal probe |
| Patient satisfaction | at the recruitment visit and 6 months postoperative | by Condition specific questionnaire asking the patient with score for satisfaction of the result and to assess the quality of life A self-administered OQLQ translated into Arabic will be used to assess quality of life at the recruitment visit and six months after the surgery. Questions 1, 7, 10, 11, and 14 will be about facial aesthetics and appearance, questions 2 to 6 will be about oral function, questions 8, 9, 12, and 13 will be about the awareness of the deformity, and questions 15 to 22 will about the social aspect of the deformity. The questionnaire contains 22 questions, and each question has score from 1 to 4, so each patient will have a score from 22 to 88. the measument tool is questionaire chart |
Contacts
Primary ContactMina ElHadidi Sobhi Ramzi
Outcome results
None listed