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To assess accuracy of patient specific 3D printed titanium plates versus 3D milled titanium plates in genioplasty orthognathic surgery
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Experimental : genioplasty using 3D printed patient specific titanium plates (study group) The first treatment plan includes fixing the chin with 3D printed patient specific titanium plates in genioplasty orthognathic surgery |
|
| control Group | Experimental | Experimental : genioplasty using 3D milled patient specific titanium plates (study group) The second treatment plan includes fixing the chin with 3D milled patient specific titanium plates in genioplasty orthognathic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genioplasty using 3D printed patient specific titanium plates (study group) | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty | 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 | immediately postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| stability of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Soft tissue dehiscence | 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 | 2 months postoperatively |
| Patient satisfaction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mina ElHadidi Sobhi Ramzi | Contact | +201225339712 | mina.ramzi@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Mounir Shaker | Cairo University | Study Chair |
| Rofaida Atef Abaas | Cairo University | Study Director |
| Mohamed Ali Zain El Abdeen Abd El Wahab |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31262680 | Background | Hanafy M, Akoush Y, Abou-ElFetouh A, Mounir RM. Precision of orthognathic digital plan transfer using patient-specific cutting guides and osteosynthesis versus mixed analogue-digitally planned surgery: a randomized controlled clinical trial. Int J Oral Maxillofac Surg. 2020 Jan;49(1):62-68. doi: 10.1016/j.ijom.2019.06.023. Epub 2019 Jun 29. | |
| 22337427 |
| Label | URL |
|---|---|
| Related Info | View source |
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the treatment include fixing the chin in genioplasty orthognathic surgery with 3D printed patient specific titanium plates
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|
| genioplasty using 3D milled patient specific titanium plates (control group) | Procedure | 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 |
|
| 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
| at the recruitment visit and 6 months postoperative |
| Cairo University |
| Study Director |
| Levine JP, Patel A, Saadeh PB, Hirsch DL. Computer-aided design and manufacturing in craniomaxillofacial surgery: the new state of the art. J Craniofac Surg. 2012 Jan;23(1):288-93. doi: 10.1097/SCS.0b013e318241ba92. |
| 17692701 | Background | Kusnoto B. Two-dimensional cephalometry and computerized orthognathic surgical treatment planning. Clin Plast Surg. 2007 Jul;34(3):417-26. doi: 10.1016/j.cps.2007.04.005. |
| Related Info | View source |
| Related Info | View source |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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