NCT Number: NCT07344441
To assess accuracy of patient specific 3D printed titanium plates versus 3D milled titanium plates in genioplasty orthognathic surgery
Trial opening soon.
Get Notified19 year–50 year
All sexes
Interventional
Not applicable
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Accuracy of Patient Specific 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgeries. A Randomized Controlled Clinical Trial
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